Catheterization Lab Equipment

273 vendors serving US medical buyers

Browse vendors of catheterization lab equipment (Cardiology) serving hospitals, clinics, laboratories, and other medical buyers across the United States. MedIndexer connects procurement and clinical-engineering teams with verified vendors supplying catheterization lab equipment. Browse detailed profiles, compare service areas, and contact vendors directly — free for buyers.

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Featured catheterization lab equipment

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TZ MEDICAL, INC.

TZ Medical, Inc. is a Portland, Oregon-based medical device manufacturer specializing in innovative solutions for cardiac monitoring, interventional cardiology, labor and delivery, and operating room applications. The company designs and produces devices including cardiac monitoring systems (TZ Monitoring Solutions), radial access procedural equipment (Cobra Board, Pannus Retention System, Runway Pro Wrist Stabilization System), and labor induction devices (Adjustable Tensioning System for cervical dilation). TZ Medical operates under a "Sparked By Your Ideas" philosophy, partnering with clinical professionals to develop practical, patient-focused solutions. The company serves acute care hospitals, cath labs, interventional radiology departments, electrophysiology labs, ICUs, and operating rooms across the United States. TZ Medical emphasizes customer support, competitive pricing, and tailored solutions for procurement needs. The company has been recognized as one of Oregon's 100 Best Companies to Work For (2017–2026). While specific regulatory certifications are not detailed on the primary homepage, the company manufactures Class II and Class III medical devices subject to FDA oversight. Products are distributed through hospital purchasing and materials management channels.

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Centerline Biomedical

Centerline Biomedical develops intraoperative navigation technology for endovascular and interventional procedures. The company's flagship product, IOPS® (Intra-Operative Positioning System), is a 510(k)-cleared navigation platform that provides real-time 3D color image guidance as an alternative to conventional X-ray fluoroscopy. IOPS® is designed to mitigate occupational and patient radiation exposure in interventional cardiology, vascular surgery, and complex endovascular procedures. The system offers interactive navigation, high-quality 3D imaging, and portability compared to traditional 2D fluoroscopy-based guidance. Clinical evidence presented on the site documents significant occupational hazards associated with fluoroscopy exposure, including radiation-induced cataracts, brain tumors, and orthopedic issues among interventionalists. IOPS® targets procedures estimated at 4 million annually in the United States. The company collaborates with major medical institutions including Cleveland Clinic, the U.S. Air Force 59th Medical Wing, and the U.S. Army Institute of Surgical Research, indicating validation in both civilian and military surgical settings. The technology is positioned for vascular surgeons, interventional cardiologists, and trauma surgeons performing endovascular therapy, aortic procedures, and complex case management where radiation dose is a clinical and occupational concern.

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FMD Co., Ltd. (株式会社エフエムディ)

FMD Co., Ltd. is a Japanese medical device manufacturer specializing in minimally invasive catheter-based therapeutic equipment, particularly guidewires for peripheral vascular interventions. The company conducts research, development, and manufacturing of guidewires essential for low-invasiveness catheter therapy. FMD operates multiple facilities including headquarters in Tokyo, a Saitama manufacturing plant, an Okinawa facility, and an R&D center. The company manufactures both OEM products for major medical device partners (including an exclusive U.S. distribution agreement with Medtronic for peripheral guidewires in 0.014" and 0.018" diameters) and proprietary branded products. Product lines include guidewire systems such as the F-14 and F-18 series, as well as electrode catheters including EPSkinny and EPLumy (lumen-bearing electrode catheter). FMD maintains quality assurance systems and serves interventional cardiology and peripheral vascular intervention markets globally, with particular focus on transradial access procedures. The company was founded in 2015 according to copyright information and maintains active partnerships with major multinational medical device companies for distribution and co-development.

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SentiAR, Inc.

SentiAR, Inc. develops holographic augmented reality (AR) and mixed reality software solutions for minimally-invasive interventional procedures, primarily in cardiology and electrophysiology. The company's flagship product, CommandEP, creates interactive 3D visualizations in real-time by integrating data from cardiac catheters and 3D electroanatomic mapping systems to display cardiac anatomy during interventional procedures. The system provides physicians with a 360-degree, interactive view of treatment delivery while maintaining sterile conditions—operators control the display via gesture-based interfaces without direct contact. CommandEP is designed for electrophysiologists, cardiologists, radiologists, and anesthetists performing catheter-based interventions. The technology addresses limitations of current imaging and visualization workflows by consolidating multiple data sources into a unified 3D representation, improving procedural accuracy, efficiency, training, and patient communication. SentiAR's AR platform enables real-time guidance during complex interventions, supports peer and resident education, and facilitates post-procedure patient explanation through holographic visualization. The company markets its solutions to interventional centers, cardiac catheterization laboratories, and teaching institutions seeking to enhance procedural precision and outcomes in minimally-invasive cardiology.

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DynaFlex Technologies Inc.

DynaFlex Technologies Inc. is a medical device manufacturer specializing in catheter design, polymer solutions, and automated manufacturing equipment for interventional cardiology and neurovascular applications. The company provides comprehensive solutions spanning catheter development (braided, coiled, deflectable, steerable, and micro-catheters), advanced polymer extrusion with medical-grade materials including multi-layer extrusion and low-durometer polymers, and semi-automated to AI-driven equipment for catheter production and rapid prototyping. DynaFlex serves neurovascular, cardiovascular, structural heart, vascular therapy, and stimulation therapy markets. The company manufactures PFAS-free polymer alternatives, including their proprietary EverGlide+ series, which is E-beam sterilizable and designed for delamination-free performance in critical clinical applications. Headquarters operations are located in Irvine, California, with additional polymer solutions facility in Yorba Linda, California, rapid prototyping laboratory in Fremont, California, and production facility in Taiwan. The company is ISO 13485:2016 certified and supports both rapid prototyping and full-scale production with seamless technology integration for OEM partners and medical device manufacturers.

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AtriCure, Inc.

AtriCure, Inc. is a medical device manufacturer specializing in surgical solutions for atrial fibrillation (Afib) management and post-operative pain management. The company's primary product portfolio centers on left atrial appendage (LAA) exclusion and surgical ablation devices. The AtriClip device family represents the company's flagship offering, with over 750,000 procedures performed worldwide and 672,000 devices sold globally. AtriClip variants include AtriClip FLEX-Mini, AtriClip Mini, and EnCompass, designed to support diverse surgical approaches from minimally invasive procedures to complex anatomies. The BoxX surgical ablation system enables comprehensive Afib treatment during cardiac procedures such as coronary artery bypass grafting (CABG). AtriCure also offers Hybrid AF Therapy, combining percutaneous and surgical approaches for long-standing persistent Afib patients. Additionally, the company manufactures cryoICE and cryoXT technologies for cryo nerve block procedures, providing non-opioid post-amputation pain management solutions. Clinical evidence supporting the product portfolio includes over 100 published studies demonstrating 100% LAA closure rates with zero leaks and zero serious adverse events at 30 days. The company serves cardiac surgeons, electrophysiologists, and general cardiologists across hospital and surgical center settings globally. Products are designed for use in operating rooms and cardiac catheterization laboratories.

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CIRCA Scientific, Inc.

CIRCA Scientific is a medical device manufacturer specializing in innovative cardiac solutions for electrophysiologists and interventional cardiologists. Founded in 2009 and headquartered in Englewood, Colorado, the company is recognized as a leader in esophageal temperature monitoring systems. CIRCA has supported over 400,000 atrial fibrillation procedures with products deployed in more than 300 U.S. hospitals and used in over 300,000 procedures worldwide. The company holds 11 patents related to cardiac anatomy and maintains FDA clearances for its products. Core offerings include the CIRCA Temperature Monitoring System™, S-CATH™ Esophageal Temperature Probe, MATRIX12 M, CrossWise™ RF Transseptal Access System, and PeriCross™ Pericardial Access Solution. These products deliver rapid and accurate temperature detection, advanced access solutions, and real-time procedural monitoring designed to reduce complications and improve patient outcomes. CIRCA's CardioCentric™ philosophy emphasizes procedural safety and clinical excellence in cardiac interventions.

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Penumbra, Inc.

Penumbra, Inc. is a global medical device company headquartered in Alameda, California, with manufacturing and service facilities in Livermore, CA and Salt Lake City, UT. The company specializes in innovative catheter-based systems for minimally invasive treatment of acute ischemic stroke, pulmonary embolism (PE), and venous thromboembolism (VTE). Primary product lines include the Penumbra System (mechanical thrombectomy platform) and the Lightning Flash series (aspiration catheter technology for PE and clot management). The Penumbra System RED comprises reperfusion catheters, separators, aspiration tubing, and aspiration pump components designed for interventional neuro-endovascular procedures treating large vessel occlusion within the intracranial circulation (internal carotid, middle cerebral M1/M2, basilar, and vertebral arteries) within 8 hours of symptom onset. Lightning Flash 3.0 represents the latest generation CAVT (Controlled Aspiration and Vacuum Thrombectomy) technology for acute PE and venous thrombus management. Products are indicated for patients ineligible for or refractory to intravenous thrombolytic therapy. The company maintains global distribution through offices in Europe, Latin America, and Canada. Penumbra devices are single-use, sterile systems requiring specialized physician training in interventional endovascular techniques. Manufacturing capabilities include precision catheter coating, sterile packaging, and quality systems supporting regulatory requirements for FDA-cleared and CE-marked devices. The company serves interventional radiology, neurovascular, and vascular surgery specialties in hospital and interventional center settings.

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Infraredx, Inc.

Infraredx, Inc., a subsidiary of NIPRO Corporation, is a vascular imaging company specializing in intravascular diagnostic systems. The company develops and markets advanced intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) imaging platforms for coronary and peripheral vascular applications. Primary products include Makoto®, a combined intravascular imaging platform that integrates high-resolution structural imaging with plaque compositional analysis for treatment planning; Clarispro® HD-IVUS, a high-definition vessel structure visualization system; and Dualpro® IVUS+ NIRS, which identifies unstable lipid-core plaques associated with major adverse cardiac events. The company also provides essential accessories including the GM-30 and NIPRO OKAY II systems. These solutions are designed for use in catheterization laboratories and interventional cardiology procedures. Infraredx serves interventional cardiologists and vascular specialists seeking advanced diagnostic capabilities for atherosclerotic disease assessment and treatment guidance. The company operates as part of NIPRO Corporation's U.S. vascular division, with organizational consolidation of U.S. subsidiaries effective April 1, 2026.

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Radiaction Medical

Radiaction Medical develops scatter radiation protection systems for interventional cardiology, electrophysiology, and fluoroscopy-guided procedures. The company's primary product, the Radiaction Smart Shield, is a dynamic barrier system that deploys at the C-arm fluoroscopy system rather than requiring personnel to wear lead aprons, reducing occupational radiation exposure by over 90% according to clinical testimonials. The system deploys and retracts in 2–3 seconds, maintaining workflow efficiency in high-volume interventional labs. Radiaction's technology is designed for use in cardiac catheterization laboratories, electrophysiology labs, and operating rooms where C-arm guidance is employed. The company has clinical validation from major academic medical centers including Assuta Ashdod University Medical Center, with endorsements from interventional cardiologists and electrophysiologists. The Smart Shield addresses a documented occupational health concern: cumulative scatter radiation exposure linked to increased risk of brain tumors, breast cancer, cataracts, cognitive degradation, thyroid disease, and orthopedic injury among interventional staff. Radiaction has established a medical advisory board and has been featured in peer-reviewed and clinical trade publications including Cardiac Interventions Today and TCT (Transcatheter Cardiovascular Therapeutics). The company targets hospital systems seeking to improve occupational safety compliance while maintaining procedural volume and staff retention in high-radiation environments.

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Innova Vascular, Inc.

Innova Vascular, Inc. is a medical device company headquartered in Irvine, California, specializing in minimally invasive solutions for treating vascular thromboembolism and peripheral vascular disease. The company develops and commercializes thrombectomy devices targeting acute pulmonary embolism and peripheral arterial occlusions. Core product line: the Laguna Thrombectomy System, which comprises the Laguna Clot Retriever™ System and Malibu Aspiration Catheter™ System. Both devices received FDA 510(k) clearance in June 2023 for use in the peripheral vasculature. Early commercial deployment has been reported at UCLA Medical Center (Los Angeles) and Providence St. Joseph (Orange, California) as of February 2024. The company is actively enrolling clinical sites for the TRUST (Treating Pulmonary Embolism With Laguna Thrombectomy System) study to evaluate the system's safety and efficacy in pulmonary embolism treatment. Founded by Dr. Sanjay Shrivastava, who brings over 20 years of medical device development and commercialization experience from senior roles at Johnson & Johnson, Medtronic, BTG plc, and Covidien/ev3. The leadership team includes board members with expertise in orthopedics, business development, and venture capital, and commercial leadership includes VP of Sales Paul Mullen and Commercial Advisor John Zehren. Regulatory: FDA 510(k) cleared. Founder holds 30+ issued US patents and numerous international patents in medical device design and materials. Markets served: interventional cardiology, peripheral vascular intervention, and acute vascular disease management at teaching hospitals and regional medical centers.

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UreSil, LLC

UreSil, LLC is a medical device development, manufacturing, and distribution company specializing in minimally invasive procedure devices and fluid drainage solutions. The company serves interventional radiology, urology, surgical/OR, CT, ultrasound, and emergency medicine markets globally. UreSil manufactures an extensive line of drainage and specialty catheters, including the NEPHRO-CATH™ nephrostomy catheter, CHOLE-CATH® biliary catheter, and NEPHRO-STENT™ nephro-ureteral stent for interventional radiology applications. In surgical settings, UreSil produces the Thora-Vent® Pneumothorax kit for air removal from the chest and the TCS300D suction wound drainage system. The company has expanded its portfolio to address emerging needs in CT, ultrasound, and emergency medicine, positioning itself as a leader in the fluid drainage market and a primary resource for complex procedural device solutions. UreSil maintains a global distribution network across six continents and provides comprehensive product documentation including instructions for use (IFUs), product sales sheets, and a global catalog. The company emphasizes innovation, quality, and relationships to improve patient care while reducing overall treatment costs. Manufacturing and distribution capabilities support both direct sales and distributor channels internationally.

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SureAx Medical Corp.

SureAx Medical Corp. is a San Diego-based manufacturer of specialized vascular access devices for lymphatic interventions and imaging procedures. The company designs and manufactures in-house innovative needles and access tools for lymphatic system procedures. Primary product lines include the SureAx-HOOK™ needle, designed for lymph node anchoring during lymphography and interstitial lymphatic embolization, and the SureAx-CURVE™ needle, engineered for accessing the cisterna chyli and thoracic duct with improved navigation and catheterization capabilities. The curved distal end and bevel-rotation design of the CURVE™ needle facilitate precise targeting and reduce procedure time. SureAx Medical serves interventional radiologists and physicians specializing in lymphatic interventions across US hospitals and international facilities. The company emphasizes close collaboration with physicians to develop tools that improve procedural efficiency and patient outcomes. Beyond product manufacturing, SureAx offers comprehensive 2-day hands-on training courses covering lymphatic imaging theory, anatomical and physiological principles, and practical applications including intranodal lymphangiography, thoracic duct access, duct embolization, and lymphoplasty techniques. The company has expanded from its initial needle focus into broader surgical applications and continues to develop new products addressing unmet clinical needs in lymphatic interventional procedures.

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HeartFlow, Inc.

HeartFlow develops AI-driven software for coronary artery disease (CAD) diagnosis and management, transforming Coronary Computed Tomography Angiography (CCTA) imaging into personalized 3D cardiac models. The company's flagship platform, Heartflow One, combines CCTA imaging with proprietary FFR_CT (fractional flow reserve) analysis to assess coronary blood flow, identify plaque characteristics, and guide treatment decisions without invasive catheterization. The Heartflow One platform comprises three core analytical modules: Roadmap™ Analysis (CAD detection and anatomy assessment), FFR_CT Analysis (functional assessment of coronary stenosis to determine revascularization benefit), and Plaque Analysis (quantitative plaque characterization for risk stratification). Additionally, HeartFlow offers PCI Navigator for pre-procedural planning in percutaneous coronary intervention. The company serves over 1,800 healthcare institutions across the United States and internationally, with coverage reaching 99.5% of the US population. HeartFlow's technology is supported by over 600 peer-reviewed publications and has been endorsed by clinical statements from the American College of Cardiology and American Heart Association for personalized CAD management. The platform addresses significant diagnostic gaps in conventional methods (stress testing, PET, SPECT), which exhibit 20–30% false negatives and 55% false positives. HeartFlow provides institutional support beyond software, including clinical, operational, technical, and financial resources for CCTA program development and scaling.

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ABK Biomedical Inc.

ABK Biomedical is a clinical-stage medical device company specializing in radioembolization and embolization technologies for cancer treatment, particularly hepatocellular carcinoma and hypervascular tumors. The company develops and commercializes proprietary imageable microsphere products designed for interventional radiology procedures. Key product lines include Eye90 microspheres, a novel yttrium-90 radioembolization technology with proprietary glass composition enabling in-procedure visualization for unresectable liver cancer, and Easi-Vue embolic microspheres, an imageable bland embolization product cleared by FDA 510(k) for treating arteriovenous malformations and hypervascular tumors. ABK Biomedical is currently conducting the Route90 pivotal clinical study evaluating Eye90 in unresectable hepatocellular cancer; enrollment was recently completed. The company holds ISO 13485 certification for medical device quality management and maintains partnerships with leading academic institutions and research organizations including Dalhousie University, NC State University, MD Anderson Cancer Center, Northwestern University, and the University of Missouri Research Reactor (MURR). Manufacturing partnerships include agreements with COR Development and Paragon Medical. The company operates as a research and development organization with headquarters in Halifax, Nova Scotia, Canada, and a development office in Orange County, California. Eye90 microspheres remain investigational and are not FDA-approved for commercial use.

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SoftLink International

SoftLink International is a healthcare IT company headquartered in India, founded in 1997, specializing in software solutions for hospital automation, clinical informatics, patient workflow management, and analytics. The company serves over 450 healthcare institutions across 15 countries, with significant deployments in the USA, Middle East, India, and Far East. Core product offerings include PANACEA (Hospital Information Management System/HIMS), a comprehensive EHR/EMR platform supporting full hospital digitization and paperless operations; Cardiology Solutions (CVIS—Cardiovascular Information System) providing multimodality viewing, cath lab inventory management, and research tools; Radiology Solutions delivering end-to-end PACS (Picture Archiving and Communication Systems) from single clinics to enterprise deployments; and TeleHealth Solutions functioning as standalone or integrated remote consultation platforms. The company maintains compliance certifications including FDA, HIPAA, ISO 9001, ISO 27001, DICOM, HL7, ICD-10, and IHE standards. SoftLink provides custom engineering, system integration, and data migration services. Known strengths include deep EHR/EMR integration experience (compatibility with EPIC, Cerner, and proprietary systems), support for non-DICOM modalities, and agile product innovation. The firm operates on a turnkey model, reducing dependency on third-party vendors. Clientele includes major hospital chains (Apollo, Fortis, Max Healthcare, Mount Sinai), government medical institutions (JIPMER), and specialty centers across multiple disciplines.

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Imricor Medical Systems

Imricor Medical Systems is a US-based medical device manufacturer specializing in MRI-compatible ablation and diagnostic catheters for interventional cardiac magnetic resonance (iCMR) procedures. Founded in 2006 and headquartered in Burnsville, Minnesota, the company pioneered safe MRI-guided cardiac catheter ablation technology. The company's flagship product, the Vision-MR Ablation Catheter 2.0, operates under real-time MRI guidance to treat cardiac arrhythmias, particularly ventricular tachycardia, with improved safety and efficiency compared to traditional X-ray fluoroscopy methods. Imricor's product portfolio also includes the Vision-MR Diagnostic Catheter, Advantage-MR EP Recorder/Stimulator for electrophysiology recording and cardiac stimulation, and the NorthStar Mapping System for cardiac substrate visualization and ablation guidance within the MRI environment. The company holds CE Mark approval in Europe and has recently obtained FDA clearance in the United States. Imricor serves approximately 15 European sites and has established partnerships including a sales agreement with Philips for broader market distribution.

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Allwin Medical Devices

Allwin Medical Devices is a leading manufacturer of specialized medical devices headquartered in Anaheim, California, with manufacturing facilities in India. The company specializes in four primary product categories: Women's Health (IVF/assisted reproduction), Urology, Gastroenterology, and Interventional Radiology. Founded by executives with over 30 years of combined experience in the medical device industry, Allwin is committed to delivering high-quality devices at affordable prices to healthcare providers globally. The company currently serves customers across multiple continents and actively participates in major medical conferences including ASRM (American Society for Reproductive Medicine), ESHRE (European Society of Human Reproduction and Embryology), and REDLARA. Recent certifications include ISO 13485 (2025), demonstrating compliance with international quality management standards for medical device manufacturers. Allwin's product pipeline includes specialty micropipettes and denuding pipettes designed for oocyte and embryo manipulation during IVF procedures, with emphasis on minimizing oocyte degeneration. The company serves fertility clinics, urology departments, gastroenterology facilities, and interventional radiology centers, positioning itself as an accessible alternative to premium-priced competitors while maintaining clinical quality standards.

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Norfolk Medical Products, Inc.

Norfolk Medical Products, Inc. is a pioneer in vascular access port (VAP) design and manufacturing, with a documented history dating to the first human implant of a vascular access port in 1982 and the first omni-directional access port in 1991. The company specializes in the development and manufacture of high-quality, cost-effective implantable access systems and solutions for interventional cardiology and oncology applications. Their flagship product, the TidalPort™, represents the company's latest innovation in dynamic vascular access port technology. Norfolk Medical provides healthcare professionals, patients, and medical facilities with implantable access devices designed to enhance patient comfort and clinical outcomes. The company operates direct sales and customer support operations across the United States and most European countries, serving hospitals, interventional centers, and healthcare systems. Their products are engineered to meet the needs of physicians, nurses, and clinical technicians who perform vascular access procedures and device management. Norfolk Medical maintains a focus on quality assurance, regulatory compliance, and user-friendly design in all product lines. The company offers direct technical and sales support, order processing, and customer information services.

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Curatia Medical

Curatia Medical is a FDA, CE MDR, and CFDA-approved interventional disposables manufacturer headquartered in Sunnyvale, CA, with manufacturing operations in Suzhou, China. Founded in 2015, the company specializes in designing, manufacturing, and distributing single-use catheters and vascular access devices for cardiac, peripheral, neuro, and pulmonary interventional procedures. The product portfolio includes angiographic catheters (URSA®), guiding catheters (XCESS®), balloon dilatation catheters (Vela™, Bilia, Navajo®), introducer sheath sets (EXTesia), distal access catheters (HW-Flex), aspiration catheters (Laredo Plus), hemostasis valve kits (AutoSeal™), and long sheath sets (Crosera). EXTesia introducer sheath received FDA approval in April 2022; Crosera long sheath set obtained NMPA approval in August 2024. The company maintains ISO 13485:2016 certification, meets FDA 21 CFR Part 820, EU MDR (2017/745), NMPA YY/T 0287-2017, and Korea GMP standards. Curatia operates a global sales network spanning more than 30 countries across North America, Europe, South America, and Asia. The company also provides OEM manufacturing services for customers. Multiple unannounced FDA and TÜV SÜD on-site audits have resulted in zero findings, demonstrating compliance with quality and regulatory requirements.

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Omega Medical Imaging, LLC

Omega Medical Imaging, LLC manufactures AI-enabled interventional imaging systems designed to reduce radiation exposure in cardiology and gastroenterology procedures. The company's core technology platform, FluoroShield™, functions as a secondary collimator using artificial intelligence to establish a Region of Interest (ROI), reducing unnecessary radiation to peripheral anatomy while maintaining image quality. Products include Soteria.AI for cardiac catheterization labs and E-View.AI for endoscopy systems, both incorporating real-time AI image guidance. The company reports radiation dose reductions up to 84% compared to conventional fluoroscopy. Omega Medical Imaging is FDA-approved for their AI-enabled X-ray systems and manufactures equipment in the United States. The company serves interventional cardiologists, gastroenterologists, and hospital interventional labs. Product lines include cardiac systems (fluoroscopy for catheterization procedures), endoscopy systems (GI/ERCP), electrophysiology labs, and surgical displays. The company emphasizes workflow integration, enabling seamless AI detection without interrupting clinical procedures. Additionally featured are TruBlock™ technology for ROI concentration and advanced image processing for both cine and fluoroscopy modes.

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ALN Implants Chirurgicaux

ALN Implants Chirurgicaux manufactures inferior vena cava (IVC) filters for temporary and permanent placement in vascular interventional procedures. Their product line includes the OATF Optional Vena Cava Filter, designed for both permanent and temporary use, with support for popliteal approach insertion. The company offers a 2-in-1 removal and repositioning kit (RK-2010) enabling filter retrieval via jugular approach and repositioning capability if clinically indicated. Clinical evidence demonstrates successful retrieval of ALN filters at 25.6 months post-placement, supporting both acute and extended-dwell applications. The company markets to interventional radiologists and vascular surgeons globally, with FDA approval indicated on their website. Products are designed with emphasis on safe handling, procedural efficiency, and retrieval reliability. The website indicates regulatory compliance and quality engagement protocols aligned with medical device manufacturing standards.

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QMD

QMD is a full-service medical device contract manufacturer specializing in silicone and elastomeric components, precision subassemblies, and finished device manufacturing. The company serves original equipment manufacturers (OEMs) across cardiology, critical care, infusion therapy, and surgical/respiratory applications. QMD's core capabilities include end-to-end manufacturing from component design through finished-device assembly, custom molded silicone and polyisoprene components (tubing, seals, valves, stoppers, duckbills), device assembly in ISO Class 7 & 8 cleanrooms, and packaging/sterilization services (ETO and gamma sterilization). Product portfolio includes coronary and peripheral vascular catheters (PTCA, PTA, aspiration), urinary catheters, enteral feeding tubes, central venous catheters, invasive blood pressure monitoring systems, chest and wound drainage products, and custom fluid management/respiratory/surgical subassemblies. The company holds FDA approvals, CE marking, 510(k) clearances, and Canadian regulatory licenses. Manufacturing capabilities span component-level customization through validated NPI processes, with private labeling and branded product transformation services. QMD operates Class 7 & 8 ISO-certified assembly facilities and provides comprehensive engineering and regulatory support to facilitate market entry for medical devices.

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Transit Scientific, LLC

Transit Scientific, LLC manufactures minimally invasive vascular intervention devices focused on peripheral vasculature and dialysis access applications. The company's primary product platform is the XO Score® Sheath Platform, an FDA 510(k) and CE Mark cleared device designed for use with percutaneous transluminal angioplasty (PTA) balloons to facilitate dilation and vessel wall apposition in treating stenotic lesions across multiple vascular territories. Indicated applications include iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, as well as obstructive lesions in native or synthetic arteriovenous dialysis fistulae. The company also offers the XO Cross® Catheter Platform, similarly FDA 510(k) and CE Mark cleared, designed to guide and support guidewires during peripheral vascular access, enable wire exchanges, and serve as a delivery conduit for saline solutions or diagnostic contrast agents. The XO Cath microcatheter line extends the portfolio for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into peripheral vessels, with demonstrated clinical use in transradial embolic delivery procedures. All products are cleared for peripheral vascular intervention but explicitly contraindicated for coronary and neuro-vascular applications. Transit Scientific positions itself within the interventional cardiology and peripheral vascular device sector, targeting interventionalists and vascular surgeons managing stenotic disease and dialysis access complications.

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Liquet Medical Inc.

Liquet Medical Inc. is a medical device company specializing in innovative vascular drug delivery solutions. The company's flagship product is the Versus Catheter, a patent-protected dual-tip infusion catheter designed for localized vascular drug delivery in the treatment of vascular disease. The device features real-time pressure monitoring and a flow-directed placement balloon to optimize catheter positioning and drug delivery accuracy. Liquet Medical's mission focuses on transforming vascular disease treatment through localized drug delivery approaches that emphasize improved patient outcomes and healthcare sustainability. The company positions itself in the interventional cardiology and vascular intervention space, addressing the need for more precise and effective drug delivery methods in catheterization-based procedures.

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ADVANCED VASCULAR DYNAMICS

Advanced Vascular Dynamics (AVD) designs, manufactures, and markets non-invasive medical devices for vascular access procedures and post-procedure hemostasis. Founded in 1998 by Dr. Herbert Semler, a pioneering interventional cardiologist, AVD specializes in devices used in Cardiac Catheterization Labs, Interventional Radiology Labs, EP Labs, critical care units, and anesthesiology settings. The company's product portfolio includes the CompressAR (used on over 15 million patients globally), ArmBoard™, ClampEase®, ComfortPress™, ExpressAR™, FlexBoard™, mBrace™, PressureMate™, RadAR™, SuperClip™, WristAssist™, Zephyr®, and surgical drapes designed for femoral and radial artery hemostasis management. All products are FDA cleared; many are CE marked for European use. AVD operates from its U.S. headquarters in Tigard, OR, and maintains an active innovation pipeline. The company also engages in partnerships with entrepreneurs and clinicians to develop new medical device solutions. Services include product distribution partnerships, custom device development, and employment opportunities in sales, regulatory, QA, and operations.

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JAM-Labs Corp

JAM-Labs Corp is a medical technology company specializing in AI-powered surgical environment solutions and operating room integration systems. The company designs and manufactures hardware, software, FPGA, embedded systems, and mechanical solutions for perioperative environments. Their product portfolio includes advanced OR recording and visualization devices, integration systems, and intelligent digital platforms that enhance surgical workflows, patient safety, and OR efficiency. JAM-Labs serves hospitals and surgical centers with solutions designed for surgeons, nursing staff, trainees, and healthcare administrators. The company emphasizes real-time data insights, automation through AI algorithms, error prevention systems, and seamless integration with existing perioperative workflows. Their offerings address OR performance optimization, staff collaboration, surgical documentation, and procedure recording with high-resolution 4K visualization. JAM-Labs targets institutional healthcare markets and has demonstrated presence in catheterization labs and surgical suite environments, with customer testimonials from hospital networks and specialized surgical centers.

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SCANLAN INTERNATIONAL, INC.

Scanlan International, Inc. is a family-owned manufacturer of precision handcrafted surgical instruments established in 1921 and based in Saint Paul, Minnesota. Operating in their fourth generation, the company specializes in cardiovascular, microsurgical, minimally invasive, and temporary occlusion surgical instruments. Scanlan manufactures reusable and single-use surgical instruments including forceps, needle holders, scissors, clamps, retractors, suction instruments, and specialized tools for VATS/MIS procedures. The company is renowned for its proprietary products such as VASCU-STATT® bulldog clamps, Reliance Bulldog clamps, and the SCANTURIAN® minimally invasive surgical instrument line. All instruments are handcrafted using premium medical-grade stainless steel and titanium with advanced coatings for enhanced durability and performance. Scanlan offers comprehensive support services including instrument restoration, modification, cleaning and sterilization guidance, warranty coverage, and custom modifications. The company collaborates closely with surgeons across specialties to design and refine instruments for evolving procedural needs, serving hospital operating rooms and surgical teams globally.

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CathWorks

CathWorks is a medical device company specializing in AI-driven interventional cardiology software and systems. The company's flagship product is the FFRangio® System, a non-invasive physiologic assessment platform used in cardiac catheterization laboratories. The FFRangio System combines artificial intelligence and advanced computational science to derive fractional flow reserve (FFR) measurements directly from routine angiographic images, eliminating the need for invasive pressure wires and drug stimulation (adenosine). The system provides real-time physiologic data at multiple points along the coronary tree, enabling interventional cardiologists to assess lesion severity and ischemia non-invasively during coronary angiography procedures. Key features include simulated pullback curves for functional CAD pattern differentiation, Lesion Impact analysis for residual ischemia assessment post-intervention, and integrated sizing tools for non-invasive lesion measurements. The CathWorks FFRangio System is deployed across major U.S. health systems including Northwell Health, Hackensack Meridian Health, Lehigh Valley Health Network, and AdventHealth, with documented adoption milestones such as Lenox Hill Hospital reaching 1,000 cases. The technology is positioned for interventional cardiologists and interventional radiologists performing coronary angiography and percutaneous coronary intervention (PCI) procedures. The company emphasizes workflow efficiency, procedural planning optimization, and improved clinical decision-making through comprehensive hemodynamic and morphologic data integration.

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ExThera Medical Corporation

ExThera Medical Corporation develops and commercializes the Seraph® 100 Microbind® Affinity Blood Filter, a single-use, extracorporeal blood filtration device designed to reduce pathogen levels in the bloodstream for patients with life-threatening bloodstream infections, sepsis, and related critical care conditions. The Seraph 100 employs proprietary microbead adsorption media with chemically-bonded modified heparin to selectively bind and remove pathogens—including bacteria, viruses, and endotoxins—from circulating blood while leaving the blood itself intact in the filter. The technology has been studied for COVID-19 treatment and is now advancing into clinical trials for broader infectious disease applications and oncology-related conditions through pipeline programs including ONCObind®. The company is advancing Phase I clinical trials (OSCAR I) for bloodstream infection management and exploring applications in pancreatic cancer treatment. ExThera's extracorporeal blood purification approach addresses a critical unmet need in intensive care settings where pathogenic load reduction can improve outcomes in sepsis, severe infections, and related hemodynamic compromise. The company maintains regulatory development pathways and publishes peer-reviewed clinical and preclinical data. Manufacturing and quality systems support single-use, sterile device production for hospital and critical care deployment.

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MiRus, LLC

MiRus is a medical device company developing proprietary implants and procedural solutions leveraging its proprietary Molybdenum-Rhenium (MoRe®) alloy technology. The company focuses on cardiovascular and orthopedic applications with an integrated platform spanning pre-operative, intra-operative, and post-operative solutions. MiRus' core technology, MoRe®, represents over 15 years of R&D and offers advantages over traditional medical materials (titanium, cobalt chromium) including smaller implant profiles, improved durability, enhanced biocompatibility, and significantly lower metal ion release. The company's cardiovascular portfolio includes the Siegel™ Transcatheter Aortic Valve (TAVR) system, currently in the STAR randomized controlled trial for symptomatic severe aortic stenosis. The orthopedic portfolio includes the IO™ Expandable Wedge Osteotomy System (FDA 510(k) cleared February 2026) and the EUROPA™ Posterior Cervical Fusion System (recipient of FDA New Technology Add-on Payment, NTAP). MiRus is headquartered in Marietta, Georgia, and was founded by experienced entrepreneurs with a track record of developing disruptive medical technologies. The company maintains an active clinical development program with multi-center trials and regulatory engagement with the FDA.

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OrbusNeich Medical Co. Ltd

OrbusNeich Medical is a Hong Kong-based manufacturer of innovative vascular intervention devices for the treatment of coronary and peripheral vascular disease. The company specializes in designing and delivering high-performance balloon catheters, stents, and specialty catheters for interventional cardiology and peripheral vascular procedures. OrbusNeich operates two primary product portfolios: Coronary (for treating heart vessel disease) and Peripheral (for treating non-coronary vascular conditions). The company emphasizes physician partnership in product development and clinical application, positioning itself as a leader in vascular device innovation. OrbusNeich maintains active engagement in international cardiology conferences and medical societies, including EuroPCR, the Oriental Congress of Cardiology, and regional vascular surgery meetings. The company demonstrates commitment to patient education and long-term quality-of-life outcomes. Products are designed for interventional cardiologists and vascular surgeons. No specific regulatory certifications (FDA 510(k), ISO, CE Mark) are explicitly mentioned on the homepage, though such devices typically require FDA clearance and CE marking for European distribution.

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Norman Noble, Inc.

Norman Noble is a Class III medical device contract manufacturer specializing in vascular and orthopedic implants. With 80 years of manufacturing experience, the company serves as a single-source solution for complex nitinol implant design and production, including vascular stents, heart valve components, heart pump devices, and neurovascular systems. For orthopedic applications, Norman Noble manufactures extremity screws, bone plates, and spine cages using precision 5-axis micro milling and turning capabilities. The company offers comprehensive services spanning design through high-volume production, with particular expertise in rapid prototyping and advanced manufacturing technologies. Core technological capabilities include proprietary Stealth athermal laser machining (HAZ-free processing), dry electropolishing, and Synchro Flash Swiss turning combined with laser machining. As the world's largest laser contract manufacturer of nitinol implants, Norman Noble develops custom manufacturing solutions for novel product designs. The company maintains state-of-the-art facilities with advanced EDM and laser processing equipment. Manufacturing services address device developers and OEMs requiring expertise in material science (particularly shape-memory alloys), precision machining, and regulatory pathway support for FDA-cleared and Class III medical devices. Norman Noble operates as a 24/7 manufacturing facility with demonstrated capability in both prototype development and commercial-scale production runs.

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Radformation, Inc.

Radformation is a healthcare technology company specializing in AI-driven automation software for radiation oncology workflows. Founded in 2016 and based in New York, the company develops intelligent tools that enhance efficiency, reduce errors, and improve cancer treatment planning across oncology clinics. Radformation's integrated platform supports the complete treatment lifecycle—from automated contouring and planning to quality assurance, treatment monitoring, and billing automation. Key offerings include AutoContour (480+ deep-learning anatomical structures), EZFluence (3D automated planning), ClearCheck (plan evaluation), ClearCalc (independent dose calculation), RadMonteCarlo (Monte Carlo calculations), ChartCheck (real-time treatment monitoring), ChartCheck Adaptive (adaptive dose tracking), QuickCode (billing QA), and RadMachine (machine QA). The platform seamlessly integrates with Eclipse™ TPS and supports photon, electron, proton, and brachytherapy modalities. With over 1,400 clinic installations and multiple regulatory clearances, Radformation enables cancer treatment centers to standardize workflows, increase patient throughput, and deliver safer, higher-quality radiation treatments.

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Nordson MEDICAL (CA), LLC

Nordson MEDICAL is a global leader in designing, developing, and manufacturing complex medical device components and technologies. The company serves interventional, surgical, and specialized medical markets, focusing on innovations that enhance patient care. As a division of Nordson Corporation, it operates facilities in the US, Mexico, and Ireland. Founded in 1968 in Colorado, Nordson MEDICAL has evolved over more than 50 years into a comprehensive provider of medical solutions. The company specializes in a wide range of products, including high-performance catheter components, fluid management solutions, and advanced surgical devices. Its offerings include medical balloons, tubing, catheters, and cannulae, delivered through trusted brands like Value Plastics, Halkey-Roberts, LinkTech, and Quest MPS®. Nordson MEDICAL emphasizes quality and precision in its products, supporting medical device developers in various sectors including cardiovascular, neurovascular, and surgical applications.

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Inquis Medical, Inc.

Inquis Medical, Inc. is a clinical-stage medical device company specializing in interventional solutions for venous thromboembolic (VTE) diseases, including pulmonary embolism (PE) and deep vein thrombosis (DVT). The company develops the AVENTUS Precision Thrombectomy System, a catheter-based device engineered for precise clot removal while minimizing blood loss during endovascular interventions. The AVENTUS system incorporates proprietary TrueClot™ Sensing technology for real-time tissue differentiation, directional aspiration for targeted clot retrieval, and integrated autologous blood return to optimize procedural efficiency and patient outcomes. The device received FDA 510(k) clearance for PE treatment in June 2025 and has completed successful clinical trials. Founded in 2019, Inquis Medical is based in Menlo Park, California, with a mission to deliver "care without compromise" in interventional cardiology and peripheral vascular medicine.

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Seigla Medical, Inc.

Seigla Medical manufactures the liquID® Guide Catheter Extension, a specialized interventional cardiology device designed for percutaneous coronary intervention (PCI) procedures. The product features an 18% larger lumen and 45% thinner wall (0.0030″ vs. 0.0050″) compared to conventional guide catheters, enabling physicians to navigate complex coronary anatomy with improved access and reduced trauma. The liquID® is available in radial-access-compatible 6Fr and 7Fr configurations, supporting both femoral and radial vascular access approaches without requiring access conversion. The company holds ISO 13485:2016 certification under the MDSAP framework and maintains CE marking in Europe. Products are distributed internationally through a global network of medical device distributors. Seigla Medical serves interventional cardiologists and cardiac catheterization laboratories in both US and international markets.

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Cardiac Dimensions, Inc.

Cardiac Dimensions, Inc. is a medical device company focused on transcatheter treatment of functional mitral regurgitation (FMR) and heart failure. The company develops and commercializes the Carillon Mitral Contour System, a percutaneous, minimally invasive device designed to treat FMR by working with the heart's natural structure and function via coronary sinus-based mitral annuloplasty. The Carillon system is delivered through a catheter-based procedure typically lasting about one hour, without preventing access to other cardiac therapies. The device is CE-marked (0344) and commercially available in Europe and other jurisdictions. In the United States, the Carillon system is currently investigational, limited to clinical trials including the EMPOWER trial, which is enrolling heart failure patients with large ventricles and FMR. Multiple published European clinical studies demonstrate improvements in patient quality of life, mitral regurgitation severity, and left ventricular volume. The company serves interventional cardiologists, heart failure specialists, and hospital cardiology programs. As of 2025, Cardiac Dimensions has completed Series E financing ($53 million raised in March 2025) and appointed William T. Abraham, MD as Chief Medical Officer. The organization maintains headquarters in Kirkland, Washington, with operations in Europe (Offenbach, Germany) and Australia (Sydney). Clinical evidence includes multiple peer-reviewed publications in European Heart Journal, JACC: Cardiovascular Interventions, and other cardiology journals documenting long-term outcomes and mechanistic benefits of the Carillon therapy.

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BALT EXTRUSION

Balt is a global medical device manufacturer specializing in neurovascular and peripheral vascular interventions. Founded in 1977 in France, the company has established itself as a premier innovator in interventional neuroradiology, employing over 800 dedicated team members across 13 offices worldwide. Balt develops a comprehensive portfolio of devices for treating ischemic and hemorrhagic strokes, as well as peripheral embolization applications. The company's product line includes balloon expandable and self-expanding intracranial stents, flow diverter stents, thrombectomy devices, and microcatheters designed with physician input. With 40+ years of excellence and distribution in 100+ countries, Balt collaborates with leading healthcare institutions and physicians to advance neurovascular intervention techniques and patient outcomes.

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Embolx Inc.

Embolx Inc. is a medical device company specializing in advanced microcatheters for arterial embolization procedures. As a subsidiary of Edwards Lifesciences, the company develops innovative solutions for interventional oncology and related specialties, including treatments for cancerous tumors, benign prostatic hyperplasia (BPH), and uterine fibroids. The flagship product, Sniper® Balloon Occlusion Microcatheter, enables precise delivery of embolic agents with controlled blood flow pressure management. The latest generation, Sniper G3 (launched July 2025), offers improved efficiency and ease of use for healthcare providers. Embolx products are available in US and European markets and serve interventional radiologists and specialists performing minimally invasive embolization procedures.

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South53

South53 is a medical device startup developing innovative solutions for vascular access procedures. The company is focused on improving safety, speed, and effectiveness of interventional radiology and interventional cardiology applications through proprietary guide wire control technology and enhanced needle visualization systems. Currently in stealth-mode development with recent seed funding, South53 is advancing toward first-in-human studies and regulatory submissions. The company's product platform emphasizes first-attempt success rates, intuitive control mechanisms, and integrated needle-guide wire designs optimized for clinical efficiency in vascular access procedures.

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STELLARTECH RESEARCH CORP.

Stellartech Research Corporation is an ISO 13485:2016-registered contract manufacturer and product development partner specializing in sophisticated medical devices utilizing radiofrequency, ultrasound, and other energy-delivery sources. The company designs and manufactures complex medical systems that typically combine disposable patient-contact devices with microprocessor-controlled instruments featuring advanced electronics for sensor feedback and controlled therapeutic energy delivery. Core competencies include catheter-based systems (including balloon electrode catheters), surgical probes, diagnostic instruments, and minimally invasive therapy devices. Stellartech operates a 68,000 sq. ft. facility capable of manufacturing Class II and Class III devices under FDA QSR compliance and ISO 13485:2016 quality management systems. Beyond contract manufacturing, the company provides full-spectrum product development services—from concept and proof-of-principle through clinical evaluation, regulatory approval, and market introduction. Stellartech partners with device companies of all sizes, medical entrepreneurs, physicians, and investment groups, offering incubation services for new medical device enterprises using its manufacturing infrastructure and regulatory expertise. The company brings integrated capabilities in RF and ultrasound energy systems, complex electronics design, catheter technology, and regulatory pathway management, positioning it as a strategic partner for medical device innovators seeking to navigate the product development lifecycle.

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Marizyme, Inc.

Marizyme, Inc. is a biomedical company specializing in the development and commercialization of medical technologies for vascular preservation and protection. The company is best known for DuraGraft®, the first and only FDA-cleared solution designed for the flushing and storage of saphenous vein grafts during Coronary Artery Bypass Grafting (CABG) procedures. DuraGraft is formulated to reduce oxidative damage during intraoperative storage, maintain cell viability, and preserve structural integrity of vein grafts. Clinical evidence demonstrates that saphenous vein grafts stored in DuraGraft exhibit significantly less wall thickening at 12 months post-CABG compared to those stored in saline. The company leverages proprietary enzyme technology and bioengineering expertise to address critical challenges in vascular graft preservation, offering solutions that improve patient outcomes in cardiothoracic surgery.

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HistoSonics, Inc

HistoSonics, Inc. is a medical device manufacturer specializing in histotripsy, a proprietary non-invasive ultrasound technology that mechanically destroys targeted tissue without surgery, heat, or incisions. Founded in 2009 by University of Michigan experts, the company has developed the Edison system—an FDA-approved, robotic, image-guided platform for the non-invasive mechanical destruction of liver tumors. The Edison system uses focused ultrasound to create a controlled bubble cloud that liquefies unwanted tissue in real-time at the sub-cellular level. With over 100 systems deployed globally and significant insurance coverage expansion (7 million BCBS Highmark members), HistoSonics is actively expanding clinical applications beyond liver oncology to kidneys and pancreas through ongoing HOPE4KIDNEY and GANNON clinical trials. The company serves interventional radiologists, surgical oncologists, hepatologists, and transplant surgeons, positioning histotripsy as a tissue-sparing alternative to traditional surgical and thermal ablation approaches for tumor treatment.

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US Endovascular

US Endovascular is a direct-to-provider distributor of coronary and peripheral interventional devices, positioned to reduce healthcare supply chain costs by eliminating unnecessary intermediaries between manufacturers and outpatient labs (OBLs), ambulatory surgery centers (ASCs), and hospitals. The company specializes in distributing next-generation endovascular and interventional cardiology devices including drug-eluting stents (DES), angioplasty balloons, guide wires, atherectomy devices, hemostatic products, and reprocessed intravascular ultrasound (IVUS) catheters. Key product lines include the Revolution peripheral atherectomy device, EluNIR PERL coronary drug-eluting stents, Parafleet tapered peripheral balloons, PTA balloons, reprocessed Philips IVUS catheters, peripheral guide wires, introducer sheath kits, and StatGuard hemostatic patches. The company operates a B2B e-commerce platform requiring account creation for pricing, targeting interventional cardiologists, vascular specialists, and procurement teams at healthcare facilities. US Endovascular emphasizes cost reduction through streamlined supply chain logistics while maintaining product quality and regulatory compliance. The company serves the interventional cardiology and peripheral vascular intervention markets across the United States.

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INDIAN WELLS MEDICAL, INC.

Indian Wells Medical, Inc. is a Southern California-based medical device manufacturer specializing in cardiology and electrophysiology procedure solutions. The company develops minimally invasive interventional devices designed to improve clinical outcomes in cardiac catheterization and electrophysiological interventions. Their primary product line includes the FlexPoint® family of steerable transseptal needles (STSN) and piercing stylets (PS), which are used in left heart access procedures and complex arrhythmia ablation interventions. These devices are engineered to provide enhanced steerability and precision in transseptal puncture applications, critical for procedures such as left atrial appendage (LAA) closure, atrial fibrillation ablation, and mitral valve interventions. The company serves interventional cardiologists, electrophysiologists, and cardiac centers performing structural heart and arrhythmia procedures. Indian Wells Medical focuses on innovation in catheterization laboratory equipment and procedural tools that enable safer, more precise cardiac interventions.

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KDL MEDICAL, INC. dba CHASE MEDICAL

Chase Medical is an ISO 13485 certified medical device manufacturer and worldwide distributor specializing in innovative technologies for advanced cardiovascular surgery. The company focuses on beating heart/off-pump CABG (Coronary Artery Bypass Graft) procedures and Surgical Ventricular Restoration (SVR). Chase Medical's product portfolio includes vacuum-assisted stabilization systems, atraumatic intracoronary shunts, surgical arms with reusable and disposable attachments, and the Mannequin system for left ventricular reshaping and restoration in ischemic heart failure patients. With over 25 years of experience and a reputation for high-quality, state-of-the-art devices, Chase Medical serves cardiac surgeons globally with both disposable and reusable surgical solutions for on-pump, off-pump, and pump-assist procedures.

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Solo-Dex

Solo-Dex manufactures the patented Fascile® Continuous Peripheral Nerve Block (cPNB) catheter system for acute pain management in pre-, peri-, and post-surgical settings. The over-the-needle technology enables single-operator placement in approximately 5 minutes, eliminating the need for complex manipulation or sterile drapes. The MRI-compatible, single-use sterile kit includes a modified Touhy-tipped needle, fenestrated memory-curve catheter, luer connectors, filters, and securement devices. Clinical benefits include avoidance of general anesthesia risks, reduced opioid dependency, accelerated surgical recovery and discharge, decreased infection exposure, and improved patient satisfaction. FDA-cleared (K151072), CE-marked, and designed by anesthesiologists for anesthesiologists, the Fascile® catheter has treated over 7,000 patients and allows continuous medication modulation for multi-day pain-free recovery.

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BOLTON MEDICAL, INC.

Terumo Aortic is a global medical device manufacturer based in Glasgow, Scotland, specializing in advanced solutions for aortic and peripheral vascular diseases. Formed in 2018 through the merger of Bolton Medical and Vascutek Ltd (both part of Terumo Corporation), the company develops and manufactures innovative endovascular and surgical devices for complex aortic pathology management. Their product portfolio includes vascular grafts, stent-grafts, fenestrated endovascular aortic repair (FEVAR) systems, intrasaccular aneurysm devices, and the TREO system. Terumo Aortic's offerings support both open-heart and minimally invasive surgical procedures, serving cardiac surgery centers and interventional vascular units globally. The company is committed to expanding treatment options and improving patient outcomes for those with complex aortic conditions through surgeon-led innovation and regulatory-compliant device development.

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Instylla, Inc.

Instylla is a privately held medical technology company based in Bedford, Massachusetts, founded in 2017. The company develops advanced resorbable embolic agents for interventional radiology, with primary clinical applications in interventional oncology and peripheral hemostasis. Instylla's flagship product, the Embrace™ Hydrogel Embolic System, is FDA-approved and represents the first and only liquid embolic approved specifically for hypervascular tumor embolization, supported by prospective randomized controlled clinical trials. The Embrace HES is a non-adhesive liquid embolic that penetrates to the capillary level, enabling targeted tumor treatment with favorable target lesion response and no recanalization. The system is designed for controlled and persistent embolization while being bioresorbable, leaving nothing behind and preserving future treatment options. The company also offers the Tembo™ Embolic System, consisting of resorbable gelatin particles for hypervascular tumor embolization and peripheral vascular occlusion. With approximately 34 employees and $7.4 million in reported revenue, Instylla has secured $63.8 million in total funding, positioning itself as an innovative leader in interventional oncology solutions.

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Vitalcor, Inc.

Vitalcor, Inc. is a U.S.-based medical device manufacturer specializing in cardiothoracic surgical instruments and devices. The company supplies hospitals, surgery centers, and integrated healthcare networks nationwide with clinically validated, FDA-cleared products including coronary artery perfusion cannulae, cardioplegia delivery systems, lighted retractors with fiber optic illumination, surgical headlights, vascular clamps and hooks, and mitral-valve surgical instruments. Vitalcor focuses on ensuring surgical supply chain reliability with real-time inventory confirmation, direct access to product specialists, and U.S. manufacturing for the majority of its product portfolio. The company has maintained operations since 1975 and emphasizes rapid problem resolution for back-ordered items and complex procedural requirements.

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USB Medical, Ltd.

USB Medical is a cardiovascular surgery device manufacturer headquartered in Hatboro, Pennsylvania, specializing in innovative surgical instruments and minimally invasive cardiac solutions. The company develops first-to-market intellectual property in cardiothoracic surgery, with a focus on retraction systems, vascular clamps, and tricuspid valve exposure devices. Key products include the HV Heart Retractor for cardiac exposure, the G2 Detachable Clamp System for vascular control, and the Pulse DEFIR device. USB Medical partners with leading cardiac surgeons globally to design and validate products that enhance procedural safety and efficiency in minimally invasive heart surgery. The company is committed to regulatory compliance and clinical validation of all surgical innovations.

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Tegra Medical Costa Rica S.A.

Tegra Medical is a global contract manufacturer specializing in end-to-end production of medical devices. Headquartered in Franklin, Massachusetts, with manufacturing facilities across the United States, Costa Rica, Switzerland, and Asia, the company employs over 1,000 people. Tegra Medical delivers comprehensive manufacturing solutions including design, prototyping, precision production, assembly, packaging, and sterilization for complex metal and plastic components. The company serves multiple therapeutic areas including oncology, orthopedics, cardiology, minimally invasive surgery, ophthalmic, women's health, drug delivery, and robotic-assisted surgery applications. Advanced manufacturing capabilities include Swiss machining, multi-axis milling, injection molding, wire grinding, and precision finishing. Tegra Medical maintains ISO 13485 certification and FDA registration, supported by rigorous quality management systems. The company also operates Quick Wire & Tubing, an e-commerce platform offering in-stock and custom wire, tubing, and secondary processing services for medical device development and prototyping.

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S4 Medical Corp

S4 Medical Corp is a Cleveland-based medical device company founded in 2017 specializing in safer catheter ablation treatments for atrial fibrillation (AF). The company's flagship product, esolution®, is the first and only FDA-cleared device designed to protect the esophagus during ablation procedures by using vacuum suction to deviate the esophagus away from the ablation catheter. This bilateral deviation capability accommodates individual patient anatomy and is compatible with any ablation energy source without requiring additional hardware or software integration. With approximately 33 million people worldwide living with AF and esophageal injury affecting up to 47% of ablation patients, esolution® addresses a critical clinical safety challenge. The device reduces thermal esophageal injury by 84%, decreases RF time by 18%, and minimizes temperature-related procedure interruptions by 9x. Designed by and for electrophysiologists, esolution® integrates seamlessly into existing catheter ablation workflows.

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Meril Endo Surgery Pvt. Ltd.

Meril Life Sciences is a global medical device manufacturer headquartered in Vapi, Gujarat, India, and founded in 2006. The company designs and manufactures innovative medical devices across multiple therapeutic specialties including cardiovascular interventions, orthopedic implants, minimally invasive endoscopic surgery tools, surgical robotics, and diagnostics. Meril operates as a multinational enterprise with 100% subsidiaries and regional headquarters spanning North America, Europe, Asia, Africa, and Australia. The company maintains a dedicated research and development function collaborating with surgeons and medical experts worldwide to address unmet clinical needs. Meril's product portfolio includes transcatheter heart valve systems (Myval THV and variants), orthopedic solutions through its Maxx Orthopedics division, endoscopic and minimally invasive surgical instruments, and robotic surgical platforms. The organization emphasizes clinical evidence generation and professional education through Meril Academy, a global platform offering fellowship programs and knowledge-sharing initiatives for healthcare professionals. Manufacturing and distribution capabilities span multiple continents, with established compliance and regulatory frameworks for markets including the United States, European Union, and Asia-Pacific regions. The company serves hospital systems, surgical centers, and healthcare institutions globally, with particular focus on advancing surgical interventions in cancer care and cardiovascular disease management.

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Teleflex

Teleflex Incorporated is a NYSE-listed (TFX) global medical technology company headquartered in Morrisville, North Carolina. The company designs, manufactures, and distributes innovative medical devices and solutions across multiple clinical specialties including anesthesia, emergency medicine, interventional cardiology and radiology, interventional urology, surgical care, general urology, and vascular access. Teleflex serves healthcare professionals and patients through a diversified portfolio of critical care and procedural products. The company recently completed the acquisition of BIOTRONIK's Vascular Intervention Business, expanding its interventional capabilities. Key product areas include anesthesia delivery systems, emergency airway and resuscitation equipment, catheterization laboratory instrumentation, urological devices (including the UroLift system), surgical instruments and staplers (such as the Titan SGS stapler for bariatric surgery), and vascular access devices. Teleflex also serves military and federal healthcare markets. The company operates Teleflex Academy, a comprehensive education platform providing training and professional development for healthcare organizations and clinicians. Teleflex maintains significant research and development capabilities with multiple design centers, supporting ongoing innovation in medical device technology. The company is recognized as a Forbes Best Employer for Engineers (2025) and received the VETS Indexes Recognized Employer Award for the second consecutive year, reflecting its commitment to recruiting and supporting veterans. Manufacturing and service capabilities span multiple geographic locations, with strong regulatory and quality management systems supporting FDA, ISO, and international compliance requirements.

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DIACOR, INC.

Diacor manufactures precision patient positioning and transfer systems for image-guided radiation oncology and hybrid operating rooms. Founded in 1983, the company specializes in the Zephyr hoverboard technology platform, which enables submillimeter-accurate patient transfer across multiple imaging modalities (MRI, CT, PET/CT, angiography) while maintaining positional integrity. Zephyr systems are designed for Image-Guided Brachytherapy (IGBT), Image-Guided Radiotherapy (IGRT), intraoperative MRI (iMRI), interventional cardiovascular MRI (iCMR), and hybrid OR procedures. The company works closely with radiation therapists, oncologists, and interventional cardiologists to develop solutions that streamline clinical workflows, reduce patient transfer time, and enhance treatment accuracy. With hundreds of global installations in premier cancer centers and hybrid ORs, Diacor provides unparalleled product support and distributor partnerships worldwide.

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HART ENTERPRISES, INC.

Hart Enterprises, Inc., founded in 1976, is a leading OEM manufacturer of specialized medical needles and custom medical devices for the healthcare industry. The company specializes in high-precision fabrication of disposable needles for arterial access, biopsy, and spinal anesthesia applications, along with custom catheter components and medical device assemblies. Hart's manufacturing capabilities include precision cutting, grinding, electropolishing, injection molding, overmolding, catheter tipping, hub assembly, and sterile packaging. Known for trauma-minimized needle designs with ergonomic hubs and ultra-sharp, burr-free cannulas, Hart serves OEM customers seeking rapid prototyping, small-batch production, and full manufacturing outsourcing with ISO 13485:2016 compliance and 510(k) clearance pathways.

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Endologix LLC

Endologix LLC is a US-based medical device company specializing in endovascular aortic repair (EVAR) solutions for patients with vascular disease, particularly abdominal aortic aneurysm (AAA). The company develops and markets minimally invasive interventional devices and systems designed to address unmet clinical needs in vascular interventions. Endologix's primary product portfolio includes EVAR systems and the DETOUR System, a novel device for peripheral vascular interventions. The company has received recognition for medical device engineering innovation and emphasizes clinical evidence-based development. Endologix is also pioneering virtual reality (VR) procedural training programs for physicians, positioning itself as an innovator in both device technology and physician education. The company is headquartered in Irvine, California, and focuses on serving interventional cardiologists and vascular surgeons through specialized vascular intervention solutions.

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Imperative Care Inc.

Imperative Care is a medical technology company specializing in innovative solutions for stroke and vascular disease interventions. Founded in 2016, the company operates four business units addressing the complete patient journey from acute intervention to post-acute recovery. The Imperative Care Stroke unit develops interventional devices including the Zoom Stroke System for rapid mechanical clot removal across a wide range of vessels in ischemic stroke patients. The Vascular unit offers the Symphony® Thrombectomy System for venous thromboembolism treatment and the Prodigy® Thrombectomy System for acute limb ischemia management. Telos Health is developing a robotic platform to enhance precision, standardization, and accessibility of vascular procedures. Kandu Health provides digital health support for stroke survivors. The company emphasizes rapid clinical innovation and partnerships with healthcare providers to improve patient outcomes across the stroke and vascular disease spectrum.

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