Catheterization Lab Equipment in Massachusetts

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.

Image Diagnostics Inc. is a US manufacturer of surgical, interventional, and diagnostic imaging equipment. Based in Fitchburg, MA, the company designs and manufactures specialized procedure tables, video integration systems, surgical lighting, suspension systems, and radiation protection products for hospitals and surgical centers. Core product lines include: Interventional/Endovascular tables featuring 4-way float technology for vascular surgery and endovascular procedures; Spine & 3D imaging tables optimized for fluoroscopic imaging without motion artifact; Pain Management and Multi-Purpose tables for interventional pain procedures; Urology tables (100UC+ model) with motorized four-way travel, elevation, and Trendelenburg tilt; Video Integration Systems (ilex duo, SKilex, ilex 58) for hybrid OR visualization across all modalities; Surgical Lighting via exclusive US distribution of SIMEON surgical lights; Ceiling and Mobile Suspension Systems; and Compass Flex Radiation Protection products. The company serves interventional radiology, endovascular surgery, spine surgery, pain management, urology, and general OR markets. Manufacturing capabilities include design and fabrication of precision surgical furniture and medical devices. ISO 13485:2016 certified for quality management in the design and manufacture of surgical procedure tables and mobile video integration devices. Products are engineered for compatibility with fluoroscopic, ultrasound, and hybrid imaging environments.

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.

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.

Enlight Medical Technologies is a global medical technology company headquartered in Boston, Massachusetts, with research and development centers and manufacturing facilities in Boston, San Francisco, Shanghai, Beijing, and Shenzhen. The company specializes in interventional medical devices for structural heart disease, vascular intervention, and neuromodulation products. The company's core therapeutic areas include: (1) valve intervention—addressing mitral regurgitation and other valvular pathologies through catheterization-based approaches; (2) aortic and peripheral intervention—treating aortic dissection and peripheral vascular disease; (3) neuromodulation—using electrode stimulation for Parkinson's disease, epilepsy, chronic pain, and urinary incontinence; and (4) brain-computer interface (BCI) technology for neurological applications and functional enhancement. The company also develops life science and diagnostic platforms, including proteomic analysis tools aligned with the Human Protein Atlas initiative. Enlight Medical maintains GMP-certified manufacturing facilities and operates across both passive and active device platforms with AI imaging capabilities. The company holds multiple medical device licenses in China and has multiple advanced clinical-stage or submitted products. Research and development teams have 15+ years of medical device engineering and production management experience. The company was founded in Boston and has expanded significantly in China, serving structural heart disease and neuromodulation markets. As of 2023, a spinoff entity (Yinghe Brain Science) completed a Series A funding round focused on next-generation neuromodulation and BCI technology development.

Sim&Cure is a medical technology company specializing in next-generation brain aneurysm treatment solutions for endovascular procedures. The company develops digital twin and AI-powered software platforms designed to support physicians in neurovascular care. Their flagship product, Sim&Size, is a surgical planning and procedural support system that leverages patient-specific computational modeling to enhance procedural planning and execution for aneurysm treatment. The platform integrates with major medical imaging and device systems from partners including Siemens, Philips, Medtronic, Stryker, MicroVention-Terumo, and others. Sim&Cure's solutions are deployed across multiple continents, serving hospitals and healthcare professionals globally. The company operates through regional product life cycle teams covering EMEA, APAC, and Americas markets. Their regulatory and quality assurance infrastructure is led by senior leadership with expertise in medical device compliance. Sim&Cure has secured significant funding (€10M Series extension as of late 2025) to advance its neurovascular procedure platform. The company positions itself as a research and innovation leader in aneurysm care, collaborating with healthcare systems to improve procedural success rates and patient outcomes through intelligent, data-driven decision support.

CardioFocus, Inc. is a medical device manufacturer specializing in innovative ablation technologies for treating cardiac arrhythmias, particularly atrial fibrillation (AFib). The company develops and manufactures advanced catheter-based pulsed field ablation (PFA) systems that emphasize precision and minimally invasive therapy. The flagship HeartLight Endoscopic Ablation System, FDA-approved in 2016, features an ultra-compliant balloon catheter with direct visualization for pulmonary vein isolation. The company's current PFA portfolio includes the CENTAURI System (the platform that defined focal PFA), OptiShot balloon catheter (investigational, designed for circumferential pulmonary vein isolation with endoscopic confirmation), QuickShot Nav catheter (investigational, a versatile large-area focal PFA device with integrated mapping and ablation), and the CardioWave System (investigational, a modular next-generation PFA generator supporting multiple catheter types). CardioFocus has treated over 10,000 patients worldwide and maintains global distribution partnerships in Japan, Europe, and China, positioning it as a key player in electrophysiology and cardiac ablation markets.

Gentuity, LLC is a medical device manufacturer specializing in next-generation intravascular imaging solutions for interventional cardiology. The company's core product is the HF-OCT™ Imaging System, a high-frequency optical coherence tomography platform designed for percutaneous coronary intervention (PCI) guidance and coronary artery disease assessment. The system integrates with the Vis-Rx® PRIME Micro-Imaging Catheter, an ultra-low-profile (1.8F) device enabling access to small, tortuous, and complex coronary vessels. Key clinical capabilities include rapid full-length vessel imaging in a single pullback, saline-compatible imaging, and real-time visualization for procedural optimization. The HF-OCT system features plug-and-play integration into catheterization laboratory workflows without requiring sterile barriers. Gentuity's products target interventional cardiologists performing complex PCI procedures, with distribution partnerships including GE HealthCare (United States), Nipro Medical Europe (EMEA), and Nipro Japan. The company holds regulatory clearance documentation including Summary of Safety and Clinical Performance (SSCP) and maintains DICOM conformance standards. Marketing emphasizes clinical case studies demonstrating utility in challenging anatomies, including critically narrow lesions and calcified vessels. The company actively participates in major interventional cardiology conferences (TCT, EuroPCR, SCAI) and publishes peer-reviewed clinical evidence.

Access Vascular, Inc manufactures vascular access devices designed to reduce complications associated with indwelling catheters. The company's primary product portfolio includes HydroPICC® (peripherally inserted central catheter) and HydroMID® (midline catheter) systems, both featuring the company's proprietary MIMIX® hydrophilic biomaterial technology. The MIMIX technology is engineered to mitigate thrombosis, a leading cause of catheter-related complications including occlusions and infections. Access Vascular's devices represent an alternative to standard polyurethane catheters and competing anti-thrombogenic/anti-microbial coated alternatives. The company emphasizes clinically demonstrated, statistically significant reductions in complications through in vitro, in vivo, and clinical data. Products are marketed toward acute care hospitals and clinical settings requiring central and midline vascular access. The company has published economic analyses suggesting potential savings of up to $1.8 million for large acute care hospitals through reduced device replacements and associated complications. Access Vascular's approach relies on intrinsic biomaterial properties rather than surface coatings or fillers. The devices target improved patient experience by reducing unnecessary needle sticks and treatment delays caused by device failure or replacement.

Angiowave Imaging develops AngioWaveNet™, a post-processing artificial intelligence platform designed for fluoroscopic angiography systems in cardiac catheterization laboratories. The software processes unprocessed angiographic cines in DICOM XA format from any traditional imaging system to enhance vasculature visualization and facilitate clinical diagnosis, particularly in patients with coronary artery disease. AngioWaveNet™ is compatible with existing fluoroscopic angiography infrastructure without requiring hardware modifications. The technology addresses a clinical need in image interpretation for coronary interventions, peripheral artery disease evaluation, stroke clot retrieval procedures, angioplasty and stent guidance, cardiac valve procedures, and electrophysiology applications. As a post-processing solution, the platform operates across diverse imaging systems in catheterization labs, trauma centers, and neurology departments. The company positions its AI-driven approach as an innovation in a mature technology segment that has experienced limited advancement over the past two decades. Angiowave offers free trial access and direct angiogram processing services through their web platform.

CardioRenal Systems develops the RenalPro (RenalGuard outside the US) autonomously-controlled fluid management and therapeutic system designed to prevent acute kidney injury (AKI) across multiple clinical settings. RenalPro is an FDA-designated breakthrough device that responds to minute fluctuations in urine output while automatically adjusting IV fluid administration in 1 mL increments to maintain hemodynamic stability and prevent over- or under-hydration. The company's primary focus is cardiac surgery-associated AKI (CSA-AKI), where approximately 30% of patients suffer kidney injury post-operatively. In a randomized 220-patient UK study, RenalPro demonstrated a 52% reduction in AKI compared to standard care with no reported adverse events. The system also addresses contrast-associated AKI (CA-AKI) in catheterization lab procedures and shows potential for ICU-related AKI prevention in septic and critically ill patients. RenalPro integrates into existing clinical workflows and represents an alternative to traditional KDIGO bundle protocols, which demonstrate limited efficacy. The company holds ISO 13485 certification and FDA breakthrough device designation, positioning it as a specialized solution for kidney injury prevention in surgical and interventional cardiology settings.

SpectraWAVE, Inc. is a medical device company specializing in innovative imaging and physiology technologies for coronary intervention. The company manufactures the HyperVue Imaging System, which combines DeepOCT+NIRS (Optical Coherence Tomography and Near-Infrared Spectroscopy) imaging with integrated physiology assessment tools. The HyperVue platform enables clinicians to acquire comprehensive coronary artery images with rapid acquisition (sub-second pullbacks with minimal or no contrast) and automated AI-powered bedside analysis to support percutaneous coronary intervention (PCI) planning and optimization. SpectraWAVE's flagship innovation is X1-FFR, a wire-free, drug-free fractional flow reserve (FFR) physiology solution that calculates FFR from a single angiogram in approximately one minute, eliminating the need for guidewires, adenosine administration, and DICOM file management delays. X1-FFR received FDA 510(k) clearance in October 2025. The integrated HyperVue with X1-FFR platform is positioned for cath labs seeking to streamline coronary diagnostics and reduce procedure time while improving treatment precision. SpectraWAVE targets interventional cardiologists and cardiac catheterization labs, offering an integrated solution that combines structural vessel assessment (DeepOCT+NIRS) with functional physiology (X1-FFR) on a single console.

Lunit International Limited is a healthcare AI software company specializing in cancer detection and precision oncology. Founded in 2013 with headquarters in Seoul and offices in Boston, the company develops clinically validated, FDA-cleared AI solutions that enhance cancer screening and treatment optimization. Lunit's modular ecosystem integrates imaging analysis, digital pathology, and biomarker intelligence across radiology, pathology, and oncology workflows. The platform serves over 10,000 customer sites across 65+ countries, with deployments focused on early detection in breast cancer, lung cancer, and personalized treatment selection through AI-powered biomarker analysis and immunohistochemistry quantification.

Abiomed is a leading manufacturer of percutaneous mechanical circulatory support systems, headquartered in Danvers, Massachusetts. The company specializes in the Impella family of heart pumps—catheter-based, minimally invasive devices designed to provide hemodynamic support and left ventricular unloading in acute heart failure, cardiogenic shock, and high-risk percutaneous coronary intervention (PCI) settings. Impella represents the world's smallest heart pump technology and is used to facilitate myocardial recovery and protect native heart function during complex cardiac procedures. The company's product portfolio includes multiple Impella configurations targeting different clinical scenarios, from acute myocardial infarction and cardiogenic shock to elective protected PCI in patients with severe coronary artery disease or advanced heart failure. Abiomed provides comprehensive clinical support services including on-site, on-call, and online technical and clinical assistance to healthcare professionals. The company maintains a global footprint with major operational centers in the United States (Danvers, Woburn, Baltimore), Europe (Aachen, Berlin), and Japan. Abiomed is a Johnson & Johnson MedTech company and operates within the cardiac support and interventional cardiology market. Clinical evidence demonstrates long-term survival benefits and myocardial recovery outcomes associated with Impella-supported procedures, supported by randomized controlled trials and registry data presented at major cardiology conferences.

Viant Medical is a vertically integrated contract manufacturing partner specializing in medical device design, development, and full-scale production. The company operates 25 global locations with 2.3 million square feet of factory space, including 299,000+ square feet of ISO-certified clean room capacity. Viant serves OEMs across multiple clinical markets: orthopedics (instruments, implants, delivery systems, UHMWPE components), surgical technologies (minimally invasive surgery, robotics, endoscopy, ophthalmology, wound care, biopsy, aesthetic surgery), cardiac and interventional devices (overmolding, nitinol tubing, hypotube precision components), drug delivery (auto-injectors, IV sets, connectors, respiratory devices), bioprocessing (containment, transfer, filtration systems), bioelectronics (pain management, sleep apnea, wearables), diagnostics and laboratory products (injection tubes, chromatography tubing), and respiratory/monitoring/patient care (masks, trach tubes, airway tubes, console components). Core manufacturing capabilities include precision metals and metal tubing, medical-grade plastics and silicone molding, extrusions, tooling, automation, device assembly, and finished device services. The company provides end-to-end solutions from prototyping through sterilization and packaging management. Viant emphasizes vertical integration to ensure quality control, reduce supply chain risk, and accelerate time-to-market. The ViaLaunch™ program offers program management support. The company focuses exclusively on medical device manufacturing and maintains operational expertise in complex assembly, overmolding, and materials science.

Global Interconnect, Inc. (Gii) is a contract manufacturing partner specializing in custom connectors, cable assemblies, and electromechanical components for energy-based and diagnostic medical devices. Established in 1995 and ISO 13485/ISO 9001 certified, Gii serves leading medical device OEMs with custom engineering, design optimization, and precision manufacturing of performance-critical sub-assemblies and finished devices. The company operates manufacturing facilities in Massachusetts, Florida, and China, emphasizing value engineering, regulatory compliance, and supply chain efficiency. Gii's expertise spans surgical instrumentation, diagnostic imaging devices, ablation systems, endoscopy equipment, and specialty medical instrumentation. Their service model combines advanced manufacturing capabilities with engineering consultation to accelerate product development, reduce costs, and ensure quality and safety standards for MedTech OEMs globally.

Summa Therapeutics is a commercial-stage medical device company specializing in advanced catheter technologies for peripheral vascular interventions. The company develops multifunctional catheters designed to improve the efficiency, safety, and economics of below-the-knee (BTK) revascularization procedures for patients with peripheral arterial disease (PAD). Summa's flagship product, Finesse BTK Multicath™, is an FDA-cleared trimodal catheter that combines crossing, diagnostic angiography, and angioplasty balloon functions in a single device. This integrated approach reduces the need for multiple catheter exchanges during complex peripheral interventions, thereby decreasing procedure time, radiation exposure, and contrast agent use—particularly important for at-risk patients with diabetes or chronic kidney disease. The Finesse product line, including the newly cleared Gen 2 injectable angioplasty balloon variant, addresses a critical clinical need in limb-salvage interventions, streamlining workflows and improving patient outcomes while reducing operator strain.

Agile Devices is a Boston-based medical device development company specializing in innovative steerable and deflectable catheter technologies for interventional procedures. The company's flagship product, the Angler® microcatheter, features active tip control technology that enables clinicians to adjust the catheter tip angle in situ during procedures. This proprietary design reduces the need for device exchanges, thereby minimizing procedure time, radiation exposure, cost, and procedural risk. The technology is particularly valuable in interventional radiology, cardiology, and neuroradiology applications where vessel navigation challenges—such as tortuosity, acute branch angles, and atherosclerotic disease—are common. FDA-cleared for peripheral and coronary vascular use, Agile Devices' steerable microcatheters address critical clinical gaps in catheter navigation, improving outcomes in complex vascular interventions including embolization procedures and coronary angiography.

Spirus Medical, LLC is a medical device manufacturer specializing in innovative gastrointestinal endoscopy and cardiology interventional devices. The company pioneered spiral endoscopy technology and currently manufactures over-tube systems for advanced endoscopic procedures. Primary product lines include the Endo-Ease Discovery® SB for small bowel enteroscopy and the Vista® Retrograde for colonoscopy—both utilizing proprietary rotate-to-advance technology that differentiates them in the market. In cardiology, Spirus offers the Dexterity™ Steerable Introducer, designed to provide physicians with proximal and distal tip steering capabilities for simplified cardiac access and anatomy navigation. The company serves gastroenterology and interventional cardiology specialists seeking advanced procedural access solutions. Based in West Bridgewater, Massachusetts, Spirus Medical focuses on bringing novel medical devices to market through engineering innovation. Contact available via phone and web form; specific regulatory certifications not explicitly detailed on website.

Haemonetics Corporation is a global medical technology company headquartered in Boston, Massachusetts, specializing in blood management, plasma collection, and vascular closure solutions for hospitals, blood centers, and plasma donation centers. The company develops innovative devices and software platforms that improve patient care quality, clinical outcomes, and operational efficiency across transfusion medicine and interventional procedures. Product portfolio includes blood collection and processing systems, plasma collection platforms, blood testing and safety solutions, and vascular closure devices. The company serves three primary market segments: hospitals (advancing surgical and critical care outcomes), blood centers (optimizing collection efficiency and blood component availability), and plasma centers (enhancing donor experience and collection yield). Haemonetics maintains FDA clearances and approvals for its portfolio, as evidenced by recent FDA approvals including expanded labeling for the VASCADE MVP® XL Venous Vascular Closure System and FDA clearance for the NexSys® PCS Plasma Collection System with Persona® PLUS Technology. The company is publicly traded and demonstrates commitment to regulatory compliance, operational excellence, and continuous innovation in transfusion medicine and interventional vascular technologies. Manufacturing and service capabilities span device production, software platforms, and customer support infrastructure.