Functional Diagnostics
190 vendors serving US medical buyers
Browse vendors of functional diagnostics (Diagnostic & Imaging Equipment) serving hospitals, clinics, laboratories, and other medical buyers across the United States. MedIndexer connects procurement and clinical-engineering teams with verified vendors supplying functional diagnostics. Browse detailed profiles, compare service areas, and contact vendors directly — free for buyers.
Featured functional diagnostics
LIFESIGN L.L.C.
LifeSign LLC is a medical diagnostic company specializing in high-quality rapid point-of-care (POC) testing solutions for the healthcare industry. The company manufactures and distributes a comprehensive portfolio of diagnostic test kits and reagents across multiple clinical specialties, including infectious disease, women's health, cardiac care, urology, gastrointestinal health, drugs of abuse screening, hygiene, and industrial applications. Key product lines include the Status™ rapid test platform, covering COVID-19/Flu A&B multiplex testing, influenza B, mononucleosis, and strep A detection. LifeSign serves hospitals, clinics, urgent care centers, and other healthcare facilities requiring rapid, reliable diagnostic results at the point of care. The company emphasizes early detection and rapid diagnosis to improve clinical outcomes. LifeSign maintains manufacturing and quality systems appropriate for medical device distribution, with products distributed through a national sales and support network. The organization is positioned as a B2B supplier of diagnostic consumables and testing solutions for various medical markets.
C-RAD Positioning AB
C-RAD is a global medical device company specializing in Surface Guided Radiation Therapy (SGRT) solutions for cancer treatment. The company develops and manufactures patient-centric, user-friendly positioning and guidance systems that enable precise radiotherapy treatments and improve clinical outcomes in oncology. C-RAD's primary product lines include the Catalyst+ platform (available in HD, LITE, PT, and HD Ring Gantry configurations), the Sentinel 4DCT system for 4D imaging during treatment, cAutoVerify automated verification software, and Visual Coaching Solutions for patient guidance. These systems deliver real-time surface imaging and tracking to ensure treatment accuracy, reduce setup errors, and enhance workflow efficiency in radiation therapy departments. The company serves cancer treatment centers, hospitals, and clinics globally through direct sales offices in Sweden, Germany, France, USA, Australia, China, and India, as well as through regional distributors. C-RAD emphasizes interoperability with existing linear accelerators and treatment planning systems, system reliability, ease of use, and comprehensive technical support. The company maintains global service support groups for installation, clinical implementation, preventive maintenance, and software upgrades throughout the product lifecycle.
Wegamed GmbH
Wegamed GmbH is a holistic medical technology company with 20+ years of experience in developing and distributing diagnostic and therapeutic wellness devices. The company specializes in non-invasive, drugless alternatives for health assessment and treatment, serving wellness professionals, clinics, and healthcare practitioners. Wegamed's product portfolio includes diagnostic devices (such as Prefit Bodyscan systems for comprehensive health analysis), therapeutic devices (Med Select for activating the body's self-healing mechanisms, and Med Matrix for whole-body detoxification), and wellness devices designed to support holistic health practices. All products are CE-certified medical devices and backed by clinical research. The company operates a comprehensive academy offering beginner and professional seminars for practitioners, and provides turnkey wellness hub solutions through Wegamed Wellness Center and Wellbeing Point offerings. Wegamed emphasizes identifying and treating underlying causes rather than symptom management, positioning its technology as a complement to conventional medical practice. The company serves international markets and works through partnerships with wellness professionals, clinics, and channel partners. Manufacturing and quality standards include TÜV certification and adherence to medical device regulations.
MEDSPIRA LLC
MEDSPIRA LLC manufactures mcompass®, a portable, easy-to-use device for anorectal manometry and pelvic floor biofeedback therapy. The device is designed for integration into diverse care settings—gastroenterology, colorectal surgery, primary care, and other outpatient clinics—without requiring dedicated space or advanced operator training. mcompass combines diagnostic anorectal manometry with manometric biofeedback therapy capabilities, enabling clinicians to assess anorectal function (including rectoanal inhibitory reflex assessment via the Quick RAIR test) and treat pelvic floor dysfunction and defecation disorders in a single compact platform. The device uses disposable catheters and completes procedures in approximately 15 minutes. MEDSPIRA also operates an online store offering accessories and consumables. The company positions mcompass as a revenue-generating, patient-retention tool for practices seeking to provide comprehensive anorectal and pelvic floor diagnostics in-house rather than referring patients to specialized centers.
MEDFEX INC.
Medfex is a B2B medical equipment distributor and manufacturer based in Mexico City with 30 years of industry experience (since 1987). The company specializes in importing and distributing diagnostic, respiratory, and orthopedic medical equipment from the USA, with all products registered with COFEPRIS and compliant with Mexican Official Standards (NOM). Medfex operates exclusively on a B2B model, selling through authorized distributors rather than directly to end users. The company serves a broad network including medical supply shops, hospitals, government agencies, and healthcare providers across Mexico, the United States, and Europe. Their product portfolio encompasses blood pressure monitoring devices (aneroid sphygmomanometers), stethoscopes, oxygen therapy equipment, and hospitalization supplies. Medfex emphasizes quality, innovation, and continuous portfolio evolution to maintain technological leadership in medical equipment distribution.
Optimetrics, Inc.
Optimetrics is South Florida's premier supplier of new and pre-owned ophthalmic equipment for ophthalmologists, optometrists, and optical retailers. The company specializes in diagnostic imaging and testing systems including corneal topographers, visual field analyzers, non-contact and applanation tonometers, fundus cameras, slit lamps, and indirect ophthalmoscopes. Optimetrics also carries surgical equipment such as portable surgical microscopes, corneal cross-linking systems, and specialized surgical instrumentation kits for cataract, glaucoma, chalazion, and pterygium procedures. The company offers factory-refurbished and reconditioned equipment from leading manufacturers including Oculus, Reichert, Zeiss, Topcon, Haag-Streit, and NIDEK, with a commitment to competitive pricing, long-lasting customer relationships, and quality assurance.
Naslund Medical Inc.
Naslund Medical Inc. manufactures the Gold Anchor, an innovative fiducial marker device designed for precision radiotherapy and surgical guidance. The Gold Anchor is a minimally invasive, gold-based fiducial marker that enables accurate tumor localization and tracking across multiple imaging modalities including kV, CT, and MR. Invented by Dr. Ingemar Naslund, an Associate Professor and head of the Division of Radiation Therapy at Karolinska University Hospital in Stockholm, the device features industry-leading thin needles for minimal invasiveness, excellent visibility across imaging platforms, and instant stability through multiple cut-outs allowing controlled marker folding. The Gold Anchor supports advanced radiotherapy techniques including stereotactic body radiation therapy (SBRT), real-time tumor tracking, particle therapy, and intrafraction motion management. Applications span breast radiation therapy and biopsy marking, lung radiotherapy and surgery, abdominal, gynecologic, prostate, and endoscopic procedures. The device is compatible with leading radiotherapy systems from Varian, Elekta, Accuray, and Brainlab, making it essential for precision oncology and surgical targeting.
ECKERT & ZIEGLER BEBIG GmbH
Eckert & Ziegler SE is a leading global provider of isotope technology for medical, scientific, and industrial applications. Headquartered in Berlin and listed on the Frankfurt Stock Exchange (TecDAX), the company specializes in cancer therapy, nuclear-medical imaging, and industrial radiometry. With approximately 1,143 employees, Eckert & Ziegler manufactures pharmaceutical-grade radioactive ingredients for cancer treatment and diagnosis. The company's core competencies include radiopharmaceutical synthesis, brachytherapy sources, hot cell solutions, and radiosynthesis technology. Its medical products segment delivers radioactive compounds for oncology and diagnostic imaging, while the isotope products segment manufactures radiation sources for medical and industrial applications. Eckert & Ziegler also develops quality control instruments and theranostic solutions, including specialized products such as Lutetium-177. The company has achieved significant market presence across Europe and North America through strategic acquisitions and partnerships.
CNMC Co., Inc.
CNMC Company is a specialized supplier of radiation physics and quality assurance equipment serving the medical radiation community. The company provides a comprehensive portfolio of dosimetry devices, ionization chambers, survey meters, brachytherapy accessories, phantoms, and calibration services. CNMC specializes in products for linear accelerator QA/QC, diagnostic radiology, brachytherapy localization, IMRT planning, and radiation protection. The product range includes electrometers, diode and MOSFET dosimeters, TLD dosimeters, ion chamber survey meters, personal dosimeters, various ionization chamber types, positioning and immobilization devices, and custom QA phantoms. The company also offers repair services and unparalleled customer support with custom product development capabilities.
CyberLogic, Inc.
CyberLogic develops FDA-approved ultrasound bone densitometry devices and advanced ultrasound simulation software. The company's UltraScan 650 is the first and only FDA-approved ultrasound bone densitometer that measures bone mineral density (BMD) using patented NTD technology, delivering DXA-equivalent accuracy without radiation exposure. The device operates in under 10 seconds, is portable and USB-powered, making it suitable for clinical osteoporosis screening and monitoring in primary care, women's health, and population screening programs. CyberLogic also offers the Wave-series software (Wave2000, Wave2500, Wave3000) for high-fidelity 2D and 3D viscoelastic wave modeling in biomedical imaging, tissue characterization, nondestructive testing, transducer design, and material characterization. Backed by 30+ years of research and peer-reviewed validation, CyberLogic serves hospitals, universities, research labs, and engineers worldwide.
Leadoptik Inc.
LEADOPTIK Inc. is a deep-tech medical device startup founded in 2020 and based in San Jose, California. The company specializes in advanced pulmonary imaging and biopsy technology for early-stage lung cancer detection. LEADOPTIK develops miniature optical probes utilizing its proprietary Last Inch Assessment™ (LIA™) Technology, which delivers high-resolution, real-time 3D microstructure imaging in ultra-thin formats. This innovation enables access to narrow lung airways that conventional bronchoscopes cannot reach, addressing a critical clinical gap in interventional pulmonology. The LIA™ Technology employs dielectric metasurfaces and nanofabrication techniques to achieve unprecedented precision in nodule assessment and biopsy guidance, reducing diagnostic uncertainty and improving patient outcomes. The company is backed by $5.25 million in funding and supported by leading venture capital partners including SOSV, Sony Innovation Fund, and Meta Venture Partners. LEADOPTIK's clinical advisory board includes pulmonologists from major academic medical centers, and the company is preparing for FDA submission.
MOOR INSTRUMENTS LTD.
Moor Instruments is a global leader in designing, manufacturing, and distributing innovative systems for non-invasive tissue blood flow and oxygen assessment. The company specializes in laser Doppler and laser speckle imaging technologies for pre-clinical, clinical, and research applications. Their product portfolio serves diverse markets including stroke research (MCAO models), hind limb ischemia (HLI) studies, microcirculation assessment, cerebral blood flow monitoring, and muscle oxygenation evaluation. Applications span neuroscience, cardiovascular physiology, diabetes research, thermoregulatory studies, and extreme environment physiology. Moor operates globally through offices in the UK, Germany, and the USA, complemented by approximately 50 regional distributors. The company is recognized for robust, reliable equipment with comprehensive after-sales support and demonstrates strong presence at major scientific conferences including the Society for Neuroscience and World Congress of Microcirculation.
NONIN MEDICAL, INC.
Nonin Medical, Inc. is a global leader in designing and manufacturing noninvasive physiological monitoring solutions. Founded in 1986 and headquartered in Plymouth, Minnesota, the company serves clinicians and consumers in over 125 countries. Nonin pioneered the world's first portable hand-held pulse oximeter and fingertip pulse oximeter, and was the first to integrate Bluetooth technology in pulse oximetry devices. The company's core product portfolio includes pulse oximeters (fingertip, wrist-worn, and handheld), regional/cerebral/somatic tissue oximeters, capnographs, and associated sensors. Nonin's proprietary PureSAT pulse oximetry technology provides accurate readings even in challenging conditions with motion, low perfusion, or variable skin tones. Primary customers include emergency medical services, hospitals, clinics, long-term care facilities, home healthcare providers, and OEM manufacturers who integrate Nonin components into their own medical devices. The company recently introduced the Nonin Health® platform, a cloud-based data management system enabling remote access to pulse oximetry results for improved workflow efficiency and clinical decision-making.
South West Exposures (2566031 ONT Inc.)
Sirona Complete Care is a specialized distributor of medical imaging accessories for Nuclear Medicine, Nuclear Cardiology, PET/CT, and molecular imaging applications. The company supplies radioactive sources, imaging phantoms, patient positioning systems, radiation detection equipment, and nuclear medicine accessories to healthcare facilities and research institutions. Sirona's product portfolio includes PET sources, survey meters, gamma detection systems, patient support systems, table pads, and theranostics solutions. Known for deep industry expertise, rapid sourcing capabilities, and personalized customer service, Sirona serves as a trusted partner to nuclear medicine technologists, cardiologists, and imaging departments across North America, with particular strength in alternative sourcing and quick-access inventory management.
Oncosoft Inc.
Oncosoft is an AI-driven software company specializing in radiation oncology workflows. The company develops an end-to-end intelligent ecosystem that supports every step of radiotherapy planning, from patient imaging through treatment planning and chart close-out. Its flagship product, OncoStudio, uses clinical-grade AI for automatic organ segmentation (auto-contouring) and organ-at-risk delineation, reducing manual contouring time from hours to minutes. OncoFlow provides integrated workflow management to eliminate errors across the entire radiotherapy process. Products under development include OncoPlan for particle therapy optimization and OncoRPT for radiopharmaceutical therapy personalization. Oncosoft supports DICOM and HL7 FHIR standards, works with 190+ normal organs and clinical target volumes, and is expanding to 300+ structures by 2025. The platform currently operates on local institutional servers with cloud deployment planned for 2026. Backed by partnerships with major Korean hospitals and expanding into U.S. and Japanese markets.
MedCAD
MedCAD is a Dallas-based medical technology company founded in 2007, specializing in patient-matched surgical devices and virtual surgical planning solutions. The company leverages advanced 3D imaging, CAD software, and precision manufacturing to design customized implants, surgical guides, and anatomical models for complex reconstructive and corrective procedures. Core offerings include the AccuPlan® Surgical Planning System for virtual surgical design, AccuPlate® 3D-printed titanium reconstruction plates, AccuShape® cranial implants in PEEK or titanium, AccuModel® anatomical models for surgical visualization, and AccuStride® foot and ankle surgical solutions. MedCAD serves cranial, maxillofacial, orthognathic, oral, plastic, and orthopedic surgery specialties. The company manufactures in-house in Texas with FDA clearance for its surgical products. MedCAD's approach combines engineer and design expertise—including trained sculptors and product designers—to create precision instruments and implants tuned to individual patient anatomy, enabling surgeons to plan procedures virtually, reduce operative time, and improve clinical outcomes.
MEDICORE CO. LTD.
MEDICORE Co., Ltd. is a South Korea-based medical device manufacturer specializing in cardiac health and autonomic nervous system assessment. The company develops diagnostic systems for heart rate variability (HRV), accelerated photoplethysmography (APG), and infrared thermography imaging. Their product portfolio serves clinical diagnostics, stress assessment, and cardiovascular health monitoring across hospital, wellness center, and personal health monitoring applications. MEDICORE positions itself as a leader in HRV analysis technology and autonomic nerve function testing, with a focus on transforming lifestyle and preventive healthcare through world-class diagnostic guidance.
CYCLOMEDICA AUSTRALIA PTY LTD
Cyclomedica is a globally recognized leader in nuclear medicine and molecular imaging, specializing in functional lung imaging. Operating under Cyclopharm Limited since 1984, the company pioneered Technegas®, a radioactive carbon nanoparticle-based diagnostic agent approved for clinical use in Australia in 1986 and now distributed across 65 countries. With over 4.7 million patient procedures delivered, Technegas® is the flagship product for advanced pulmonary diagnostics. The company's core competency encompasses nuclear pulmonology imaging with multiple product variations including Pertechnegas® and Galligas, supported by the TechnegasPlus generator. Cyclomedica actively pursues expanded clinical indications beyond pulmonary embolism, including COPD, asthma, chronic thromboembolic pulmonary hypertension, pre-operative quantification, radiotherapy planning, and COVID-19 complications. The organization maintains a strong regulatory compliance posture and operates a global network of regional offices and distributors to support healthcare providers in respiratory patient management and clinical outcomes improvement.
Epsilon Elektronik Sanayi ve Tic A.S
Epsilon Elektronik Sanayi ve Ticaret A.Ş. is a Turkish medical equipment distributor and solution provider established in 1993, based in Istanbul with over 30 years of specialization in nuclear medicine, radiation oncology, and medical imaging. The company holds ISO 13485:2016 and ISO 9001:2015 certifications and serves as the authorized distributor for leading international manufacturers including IBA Dosimetry, Mirion/Capintec, QFix, Modus QA, CLERAD, and LabLogic. Epsilon offers comprehensive services including turnkey nuclear medicine center project management, technical support, calibration, and quality control testing for dose calibrators and gamma cameras. The company develops proprietary innovations such as Ge-68 calibration sources, I-125 tumor localization seed sources, and Co-57 flood sources for SPECT/PET imaging systems. Additional product portfolio includes radiation protection equipment, lead shielding products, water phantoms, patient positioning and immobilization devices, dosimetry systems, and decontamination solutions. Epsilon engages in international trade, exporting to the Netherlands, China, and importing from the United States and Russia, positioning itself as a comprehensive B2B solution partner for hospitals, imaging centers, and radiation therapy facilities across Europe and Asia.
Lucerno Dynamics, LLC
Lucerno Dynamics develops, manufactures, and markets the Lara® System, a passive skin sensor platform designed to detect and quantify radiolabeled biomarkers during nuclear medicine procedures. The system identifies radiopharmaceutical extravasations in seconds, evaluates injection impact within minutes, and reduces error frequency over time. Lara provides real-time quality control and assurance for nuclear medicine administrations, supporting patient-specific dosimetry and therapy response monitoring in solid tumors. With over 28,000 monitored administrations, Lucerno addresses a significant clinical gap: approximately 4.5 million extravasations annually occur in U.S. nuclear medicine procedures, with 500,000+ classified as significant. The system requires minimal patient experience impact (20 seconds added) and technologist workflow disruption (1 minute), making it practical for high-volume clinical settings seeking to enhance safety and procedural confidence.
MEDACURE INC
MedaCure Inc. is a manufacturer and distributor of durable medical equipment (DME) and supplies headquartered in Kenilworth, New Jersey. The company designs and manufactures a comprehensive range of products for senior healthcare, long-term care, homecare, and behavioral health settings. MedaCure's product portfolio includes long-term care beds, patient lifts and slings, wheelchairs, bariatric equipment, bathroom safety products, mattresses, patient room furniture, and respiratory and diagnostic devices including portable oxygen concentrators and bladder scanners. The company operates distribution centers across the USA to ensure rapid delivery and provides professional consultation services to healthcare facilities for product selection. MedaCure emphasizes quality, competitive pricing, and rigorous quality control standards supported by ongoing research and staff training. The company also offers warranty servicing and supports both institutional buyers and homecare providers with equipment tailored to enhance patient safety and comfort.
INBIOS INTERNATIONAL, INC.
InBios International, Inc. is a privately-held biotechnology company specializing in the design, development, and manufacture of immunodiagnostic devices for infectious diseases and biothreats. Founded in 1996 and headquartered in Seattle, Washington, the company operates a state-of-the-art GMP-compliant, FDA-registered manufacturing facility certified to ISO 13485:2016. InBios maintains a portfolio of over 25 FDA-cleared diagnostic products and extensive life science reagent catalogs. Core offerings include ELISA kits, rapid point-of-care tests, and contract manufacturing services for emerging infectious disease diagnostics. The company delivers immunoassays targeting dengue, West Nile virus, Zika, Chagas disease, leishmaniasis, COVID-19, influenza, and biothreats such as anthrax and melioidosis. InBios provides comprehensive assay development, regulatory affairs support, and contract manufacturing capabilities to clinical laboratories, public health agencies, research institutions, and OEM partners globally. The company is recognized for rapid response to emerging disease threats while maintaining rigorous quality standards and cost-effective solutions for the global diagnostic market.
SANDERS MEDICAL PRODUCTS, INC.
Sanders Medical Products Inc manufactures calibration sources and quality control solutions for Positron Emission Tomography (PET) and nuclear medicine imaging equipment. Since 1994, the company has specialized in PET sources approved by all major scanner manufacturers including Siemens, GE Healthcare, Philips, Concorde, Hamamatsu, Positron, and Shimadzu. Sanders Medical provides proprietary calibration sources designed to ensure scanner consistency and imaging quality, along with comprehensive services for PET facility maintenance and scanner normalization. The company offers lifetime warranty on sources and maintains a dedicated focus on medical imaging calibration and quality assurance.
PediaMetrix Inc
PediaMetrix is a healthcare technology company specializing in AI and computer vision solutions for pediatric care. The company's flagship product, SoftSpot™, is the first and only FDA-cleared mobile application for point-of-care measurements of infant head deformity conditions, including positional plagiocephaly and other cranial abnormalities. SoftSpot enables both pediatric providers and parents to perform quantitative, repeatable head shape assessments using smartphone-based computer vision technology, supporting early detection and monitoring in clinical and home environments. The platform is designed for telemedicine and in-office use, with results interpreted by qualified healthcare professionals. PediaMetrix also offers Tummy Time Tools to support infant developmental activities. The company's mission is to make advanced measurement technology accessible to improve patient outcomes and reduce costs in pediatric healthcare delivery while maintaining robust data security through encryption systems.
Infervision US Inc
Infervision is a global medical artificial intelligence company founded in 2015, specializing in deep learning technologies for medical imaging and clinical diagnostics. Headquartered in Beijing with a US office in Lyndhurst, New Jersey, Infervision develops AI-powered platforms designed for radiologists and clinicians to enhance diagnostic accuracy and clinical workflows. The company's InferRead™ suite processes over 33,000 exams daily and provides comprehensive imaging analysis across multiple organ systems including lungs, cardiovascular, breast, and bone. InferOperate™ offers surgical planning and intraoperative navigation, while InferScholar™ and InferMatrix™ platforms support medical research and innovation. Infervision's solutions assist in detecting conditions such as lung cancer, stroke, pneumonia, tuberculosis, and fractures from various imaging scans. The company holds regulatory approvals from the US FDA, China NMPA, EU CE, UK UKCA, and Japan PMDA, with products deployed across 1,000+ medical institutions in 30+ countries.
Sleep Group Solutions
Sleep Group Solutions is a leading provider of Dental Sleep Medicine (DSM) training and airway diagnostic technology for dental professionals. The company delivers comprehensive continuing education programs that equip dentists and physicians with the clinical knowledge and business tools needed to establish and expand sleep medicine practices. Founded by Rani Ben-David, Sleep Group Solutions has trained over 17,000 dentists across North America. The company offers three core service pillars: hands-on, in-office training delivered by practicing sleep dentists; turn-key business solutions covering patient acquisition, treatment planning, medical billing, and sleep testing logistics; and proprietary airway diagnostic equipment including the Eccovision Acoustic Diagnostic Pharyngometer and Rhinometer. Training programs emphasize practical application, covering patient identification and screening, appliance selection, chair-time optimization, medical billing compliance, and physician referral management. Sleep Group Solutions is accredited by PACE, ASBA, and AGD, ensuring compliance with continuing education standards. The company's instructor cohort actively treats sleep apnea patients in clinical practice, providing evidence-based insights and real-world case studies.
VASSOL, INC.
Vassol, Inc. develops NOVA (Noninvasive Optimal Vessel Analysis), an advanced 3D blood flow analytics and imaging software platform for quantitative hemodynamic analysis of cerebral vasculature. NOVA integrates with standard MRI systems—specifically Time-of-Flight MRA and 2D phase-contrast magnetic resonance imaging—to generate three-dimensional vascular models and quantify intracranial blood flow without contrast agents or radiation exposure. The platform is vendor-neutral, PACS-compatible, and features automated processing with patented algorithms for perpendicular scan plane prescription. Clinically validated over 20+ years, NOVA serves neuroradiologists and stroke specialists for diagnosis, treatment planning, and post-intervention assessment of cerebrovascular conditions including carotid stenosis, vertebrobasilar disease, arterial dissection, aneurysm management, and moyamoya disease. An NIH study demonstrated NOVA qMRA® as a robust, independent predictor of recurrent stroke risk.
Semler Scientific, Inc.
Semler Scientific is a medical technology company specializing in early detection and management of vascular diseases, particularly peripheral arterial disease (PAD). Founded in 2007, the company develops point-of-care diagnostic devices and digital health platforms for cardiovascular assessment. QuantaFlo, its flagship product, is an FDA-cleared non-invasive test measuring arterial blood flow in extremities, enabling rapid diagnosis of PAD in both symptomatic and asymptomatic patients. The company also provides complementary solutions including SemlerShield (data security), SemlerVault (data management), SemlerAnalytics (clinical analytics), SemlerSimulation (provider training), and SemlerHub (cloud-based diagnostic platform). Semler Scientific serves healthcare providers seeking portable, evidence-based tools for vascular disease screening and monitoring, addressing the significant clinical and economic burden of PAD, which affects approximately 1 in 5 people over age 60 and costs the U.S. healthcare system over $216 billion annually.
AIDIAN OY
Princeton BioMeditech Corporation (PBM) is a world leader in rapid, point-of-care diagnostic products. The company manufactures and distributes an extensive portfolio of over 70 different one-step rapid diagnostic tests utilizing patented immunoassay technologies. PBM serves both consumer in-home and professional on-site/point-of-care markets with FDA-cleared and ISO 13485:2016 certified products. Product lines include rapid antigen detection tests for COVID-19/Flu, cardiac markers, infectious disease diagnostics, fertility testing, drugs of abuse screening, tumor markers, and food/environmental pathogen detection. The company offers OEM services, point-of-care analyzer systems, research and development capabilities, and comprehensive product support. Based in Princeton, New Jersey, PBM maintains USA manufacturing operations and serves healthcare providers, clinical laboratories, and consumers globally.
PHASE Diagnostics
PHASE Diagnostics is a diagnostics technology company specializing in rapid and at-home testing solutions powered by proprietary PHASIFY™ technology. The company develops innovative diagnostic offerings focused on early detection and prevention, with particular emphasis on cancer and infectious disease screening. PHASE offers three primary product lines: INDICAID rapid tests for point-of-care use, INDICAID lab at-home laboratory tests, and PHASE lab medical testing services. The PHASIFY™ technology platform enables rapid detection of target molecules, supporting urine-based and other non-invasive screening methods including HPV cervical cancer screening and respiratory pathogen detection. The company holds FDA CLIA waiver status and conducts clinical studies to validate diagnostic accuracy. PHASE positions itself at the intersection of preventive healthcare and diagnostic innovation, targeting both consumer self-testing and clinical laboratory markets.
Yostra Labs Private Limited
Smart-ABI, developed by Hyperion Medical, is a cloud-based diagnostic solution specializing in Ankle Brachial Index (ABI) testing combined with Pulse Volume Recording (PVR) for the rapid, non-invasive diagnosis of Peripheral Artery Disease (PAD) and related vascular conditions. With over 25 years of medical device industry experience, the Smart-ABI platform delivers fast, simple, and accurate vascular assessments that integrate seamlessly into existing electronic medical record systems. The Smart-ABI Hub is a HIPAA-compliant software-as-a-service platform that enables mobile access, collaborative care between providers and specialists, and secure report transmission. The company's comprehensive vascular testing solutions—including the core Smart-ABI device and Smart-LEDA for combined ABI and sudomotor function assessment—are designed to improve early diagnosis of underdiagnosed PAD, reduce major cardiovascular and limb events, and support evidence-based clinical decision-making in diverse care settings.
YIWEI Medical Technology Co., Ltd.
YIWEI Medical Technology (Dr. Brain) is an AI-powered diagnostic platform specializing in central nervous system (CNS) disease detection and brain health management. Founded in 2017 in Shenzhen, the company leverages a comprehensive Chinese brain imaging database, cloud computing, and advanced AI algorithms to deliver intelligent imaging analysis and diagnostic support across multiple neurological conditions including Alzheimer's disease, mild cognitive impairment, Parkinson's disease, stroke, brain tumors, and autism spectrum disorders. The platform comprises four primary solutions: Dr. BrainCloud (intelligent imaging diagnostic platform for CNS disease assessment), Dr. Brain Tele (cloud-based tele-imaging platform supporting remote consultation and expert review across primary care facilities), Dr. Brain Pharm (neuropharmacological efficacy evaluation system for clinical drug development and R&D), and Dr. Brain Health (comprehensive brain health management services including AI-based whole-brain examination, disease prevention, VR-based cognitive rehabilitation training, and patient counseling). The company integrates quantitative structural brain analysis, personalized VR-based cognitive assessment using eye-tracking technology, and immersive rehabilitation training protocols to improve diagnostic accuracy and enable early intervention.
Medscience Research Group, Inc.
MedScience Research Group, Inc. is a specialized manufacturer of allergy skin testing devices and applicators. The company develops and distributes state-of-the-art diagnostic equipment for allergen testing, including the ST-Family Skin Test Devices and AllerTest™ product lines. MedScience's skin test applicators feature hardened plastic tines engineered for precision, consistency, and minimal patient discomfort during allergy diagnostics. The company's technology is protected by seven patents and has been trusted by clinicians nationwide for reliable allergen identification and assessment.
Wenzel Spine, Inc.
Wenzel Spine, Inc. is a medical technology company founded in 2008 and headquartered in Austin, Texas, specializing in minimally invasive surgical solutions and diagnostic platforms for spinal disorders. The company is a recognized leader in stand-alone spine fusion technologies with over 17 years of expertise in expandable implant design and manufacturing. Wenzel Spine develops a comprehensive portfolio of devices designed to simplify spine surgery, reduce recovery time, and improve patient outcomes while preserving spinal anatomy and minimizing hardware burden. The company's mission emphasizes a "less is more" approach, often eliminating the need for supplemental fixation. With 21,000+ devices implanted, 11,000+ patients treated, and 300+ surgeon partners across North America and the European Union, Wenzel Spine maintains a strong commitment to ethical practices and regulatory compliance. The company serves orthopedic surgeons and spine specialists treating sacroiliac, lumbar, and cervical fusion patients through both innovative surgical systems and diagnostic software.
Apollo BioTech co., ltd.
Assaya is a Singapore-based medical technology company specializing in rapid diagnostic solutions. The company's flagship product, the iaX Intelligent Analyzer, is a universal, portable rapid diagnostic reader that converts qualitative lateral flow assay (LFA) results into quantitative, machine-read data with cloud connectivity. The iaX eliminates subjectivity in test interpretation—addressing the 80% misread rate common in manual LFA reading—and delivers lab-grade diagnostic accuracy at the point of care in seconds. Compatible with rapid tests from major manufacturers (Abbott, BD, Roche, Abnova) without brand lock-in, iaX automatically syncs results to secure cloud storage with full metadata for EHR/LIMS/ERP integration. The platform supports human health diagnostics, livestock disease detection, aquaculture health monitoring, food safety screening, environmental and water testing, and public health/emergency response. Assaya's technology represents a cost-effective alternative to centralized PCR testing, enabling decentralized diagnostics across clinical, field, farm, and remote settings while maintaining regulatory compliance (FDA Class I IVD, IVD-CE, IVDR-EU, ANVISA).
Alimetry Ltd
Alimetry Ltd is a medtech company specializing in advanced wearable medical devices and AI-driven diagnostics for gastrointestinal disorders. Founded in 2019 by Dr. Greg O'Grady and Dr. Armen Gharibans, the company operates from Auckland, New Zealand with expanded operations in the US, serving over 2,500 patients. The flagship product, Gastric Alimetry™, is an FDA-cleared and CE-marked non-invasive diagnostic system that performs Body Surface Gastric Mapping (BSGM) to record gastric electrophysiology over a 4.5-hour session. This technology aids clinicians in diagnosing complex gastric disorders including gastroparesis and motility issues by providing objective, data-driven insights into gastric function and electrophysiology. The system features an adhesive electrode array placed on the patient's abdomen, integrated symptom logging via mobile app, and an auto-generated diagnostic report with validated normative values. Alimetry Care, a developing home-monitoring wearable and remote care service, aims to expand accessibility for patients with chronic GI symptoms and supports personalized medicine approaches.
IntuiTap Medical, Inc
IntuiTap Medical is a Houston-based medical device company specializing in real-time tactile imaging technology for spinal procedures. The company's flagship product, VerTouch, is an FDA-cleared bedside imaging device designed to enhance the accuracy and safety of neuraxial procedures including epidurals, lumbar punctures, and spinal anesthesia. VerTouch generates real-time anatomical maps (TactoMaps) of the lumbar spine to help clinicians accurately identify needle insertion sites, reducing variability, patient pain, and the need for radiology escalations. The technology features a sterilely-covered reusable monitor with disposable handheld scanning components and requires minimal training, enabling consistent performance across diverse provider types (physicians, PAs, CRNAs). Founded in 2016 with $5.6M in funding, IntuiTap Medical serves emergency, anesthesia, oncology, and neurology settings, addressing critical gaps in bedside spinal care delivery.
Novascope Biochips Inc.
Novascope Biochips Inc. is a diagnostic platform developer pioneering next-generation point-of-care and laboratory diagnostics using proprietary BioChips Reaction (BCR) technology. The platform delivers ultra-high sensitivity detection of DNA, proteins, and small molecules with quick turnaround times, multiplexing capability, and minimal sample volumes. Applications span lab medicine, primary care, and point-of-care testing (POCT). The company emphasizes secure data transfer to mobile devices, making results accessible in clinical and home-care settings. Core strengths include affordability, rapid analysis, and comprehensive healthcare application coverage from centralized laboratory to decentralized primary care environments.
Gold Standard Diagnostics
Gold Standard Diagnostics (GSD) is a global diagnostic solutions provider headquartered in Dietzenbach, Germany, specializing in the development, manufacturing, and commercialization of diagnostic test kits, reagents, instruments, and automation systems. Formed through strategic mergers including Virotech Diagnostics and Novatec Immunodiagnostica, GSD serves clinical, food, feed, environmental, biopharma, veterinary, and animal health sectors. The company offers comprehensive diagnostic workflows including ELISA test kits, PCR assays, lateral flow devices, and automated platforms for virology, bacteriology, oncology, allergen detection, food pathogen identification, and mycotoxin analysis. GSD provides magnetic separation solutions, culture media, sampling devices, and reference materials. All products emphasize quality and compliance with CE-IVD marking under EU regulations. Services include antibody development, technical support, and training for laboratories, healthcare professionals, and research institutions.
FLUXERGY INC.
Fluxergy Inc. is a medical diagnostic company specializing in multimodal point-of-care diagnostic platforms that integrate molecular testing (PCR), immunochemistry, cytometry, and electrochemistry on a single analyzer. Founded in 2013 and based in Irvine, California, Fluxergy develops automated, sample-to-answer diagnostic systems delivering results in under one hour. The company's open platform ecosystem comprises the Fluxergy Analyzer (the core instrument), proprietary test cards supporting multiplex and multimodal assays, and Fluxergy Works (intuitive software for test execution and result visualization). With over 500 test systems manufactured and 100,000 test cartridges produced, Fluxergy serves healthcare providers, diagnostic laboratories, and veterinary practitioners. The platform addresses the current clinical fragmentation requiring multiple POC devices by consolidating molecular, immunochemistry, cytometry, and electrochemical detection into one cost-effective instrument. Applications include infectious disease diagnostics, sepsis assessment, and veterinary pathogen detection (equine respiratory pathogens, Salmonella, Streptococcus equi). Currently in Series C funding with established OEM partnerships and clinical validation from leading academic institutions and veterinary hospitals.
Precision Medical Ventures, Inc. dba RevealDx
RevealDx is a Seattle-based software company delivering FDA-cleared AI-powered lung cancer decision support software. The company has developed RevealAI-Lung, an advanced radiomics and artificial intelligence platform for non-invasive lung nodule characterization and malignancy risk assessment. The platform generates a Malignancy Similarity Index (mSI™) score to help clinicians confidently identify lung cancer type without invasive biopsies or surgeries. The software features single-click operation with results displayed within seconds, enabling actionable radiomic insights while reducing unnecessary procedures and associated healthcare costs. RevealDx holds FDA clearance and MDR certification, positioning it as a leader in AI tools for precision lung cancer diagnosis and improved patient outcomes.
CHEMBIO DIAGNOSTIC SYSTEMS, INC.
Chembio Diagnostics, Inc. is a leading developer and manufacturer of rapid point-of-care (POC) diagnostic tests for infectious diseases, headquartered in Hauppauge, New York, with operations in Medford, New York. The company specializes in innovative diagnostic solutions utilizing its proprietary Dual Path Platform (DPP®) technology, which delivers improved sensitivity, multiplexing capabilities, and rapid results from a small sample of fingertip blood. Chembio's product portfolio includes FDA-approved and CLIA-waived assays for HIV, syphilis, Hepatitis C, COVID-19, and emerging infectious disease detection. The company also develops quantitative diagnostics (FastPack® hCG) and is actively advancing diagnostics for typhoid fever and preeclampsia. With 337 employees and approximately $55.3 million in annual revenue, Chembio markets its solutions to medical laboratories, hospitals, government health agencies, NGOs, and retail establishments across the United States and internationally. The company is committed to delivering exceptional, easy-to-use, fast, and accurate diagnostic solutions to enhance health outcomes in infectious disease detection and monitoring.
OraSure Technologies, Inc.
OraSure Technologies, Inc. is a leading developer and manufacturer of non-invasive diagnostic testing devices and oral specimen collection tools for infectious disease detection. The company's core portfolio includes rapid point-of-care tests for HIV, hepatitis C (HCV), hepatitis B (HBV), syphilis, Ebola, and COVID-19 (InteliSwab). OraSure markets products under multiple brands including OraQuick (rapid antibody tests), SureQuick (rapid tests), and proprietary specimen collection devices. The company also operates through subsidiaries: DNA Genotek (sample collection and preservation solutions for genomic, metabolomic, and microbiome research), Sherlock Biosciences (rapid diagnostic test development), and BioMedomics (sickle-cell rapid testing). Products are distributed globally through direct sales, online ordering, and healthcare provider networks. OraSure serves public health authorities, clinical laboratories, healthcare practitioners, researchers, and retail channels. The company emphasizes accessibility and decentralization of diagnostics, particularly for underserved populations and resource-limited settings. Manufacturing and quality standards align with FDA regulatory requirements and international standards. Customer support includes product training, technical documentation, and dedicated customer care with phone and email channels available for U.S. and international markets.
LEX Diagnostics Ltd
LEX Diagnostics Limited (now acquired by QuidelOrtho) is a molecular diagnostics company specializing in ultra-fast point-of-care PCR testing platforms. Based in Melbourn, United Kingdom, the company develops the LEX VELO system, a CLIA-waived compact PCR molecular diagnostics platform designed for decentralized healthcare settings including physician offices, urgent care centers, pharmacies, and hospitals. The LEX VELO system delivers lab-quality results with minimal hands-on time (less than one minute), reporting positive results in as little as six minutes and negative results in under ten minutes. The current test menu includes multiplex detection and differentiation of Influenza A, Influenza B, and COVID-19, with planned expansion to include Strep A, RSV, and STIs. The system features a fully automated swab-to-result workflow with no swab elution or liquid sample handling required, significantly reducing infection risk and operational complexity in point-of-care settings.
Healthy.io Ltd.
Healthy.io Ltd. develops smartphone-based clinical diagnostic solutions using computer vision, colorimetric analysis, and AI algorithms to enable remote patient testing from home. The company's core offering transforms a patient's smartphone camera into a clinical-grade medical device capable of analyzing urine tests for early detection of kidney disease and chronic wound assessment. The platform is FDA-cleared and CE-marked, featuring seamless EMR integration via SMART on FHIR standards. Products include Minuteful Kidney for home-based kidney function testing and Minuteful Wound for wound care assessment. The company partners with health systems, health plans (including Medica and Blue Cross of Idaho), and wound care providers to improve screening completion rates, advance health equity, and close the care loop with post-test services. The technology operates across varying devices and lighting conditions, achieving 93% patient satisfaction and up to 50% completion rates among previously untested populations. Healthy.io targets at-risk patient populations, rural communities, and healthcare systems seeking to address the gap where 90% of individuals with chronic kidney disease remain undiagnosed.
Longhorn Vaccines and Diagnostics LLC
Longhorn Vaccines and Diagnostics LLC is a veteran and family-owned biotech company with over 35 years of experience in human and animal public health. The company develops diagnostic tools, vaccines, and monoclonal antibodies targeting infectious diseases, antimicrobial resistance, and inflammatory conditions. Core products include PrimeStore® MTM, an FDA-cleared Class II molecular transport media (predicate device) for pathogen inactivation and RNA/DNA preservation in clinical samples; Salorn STM, a virucidal sample collection device for antigen testing; PrimeScreen MTB™, an oral screening kit for tuberculosis detection; PrimeSeqMDR, optimized PCR primers and reagents for MTB resistance gene amplification; and PrimeXtract™, a nucleic acid extraction system. In vaccines and therapeutics, Longhorn develops composite peptide vaccines addressing bacterial sepsis and antimicrobial-resistant infections, and monoclonal antibodies (e.g., LHNVD-501, LHNVD-303) targeting multi-drug resistant bacterial pathogens. The company is recognized by FDA, WHO, USDA, UK Health Department, and NHS. Manufacturing and supply partnerships are based in the United States, ensuring quality and accessibility. Longhorn's products address sample collection, transport, nucleic acid extraction, molecular testing, and therapeutic prevention of infectious and inflammatory disease.
Radiopharmaceutical Imaging & Dosimetry, LLC
Radiopharmaceutical Imaging and Dosimetry (Rapid), LLC is a Baltimore-based biotechnology research company founded by Johns Hopkins University experts (Drs. George Sgouros, Eric Frey, and Michael Ghaly). Rapid specializes in quantitative imaging, dosimetry analysis, and precision medicine support for radiopharmaceutical therapies, particularly in oncology. The company provides comprehensive consulting and centralized solutions covering the full workflow from image acquisition protocol development through regulatory support and dosimetry reporting. Services include agent-specific imaging protocol design, centralized vendor-independent SPECT/CT quantitative reconstruction with advanced scatter and crosstalk compensation, and expert dosimetry analysis to optimize patient outcomes and reduce normal organ toxicity. Rapid also develops software solutions, including 3D-RD-S, a SaaS platform for radiopharmaceutical dosimetry calculations and radiobiological response modeling. The company combines 45+ years of NIH-funded research and development experience to standardize and simplify dosimetry for routine precision dosing of radiopharmaceutical therapies.
3CPM Company, Inc.
3CPM Company, Inc. is a US-based medical device manufacturer specializing in electrogastrography (EGG) diagnostic systems for gastrointestinal motility disorders. The company's proprietary technology combines miniaturized hardware with AI-driven software for non-invasive characterization of gastroparesis, functional dyspepsia, and related GI conditions. The EGG platform features a simple 45-minute test protocol with automated signal acquisition and evidence-based diagnostic interpretation. 3CPM's patented technology enables disease subtyping to optimize personalized treatment selection and identify potentially curable subsets of patients (25% of gastroparesis and dyspepsia cases). The system provides objective diagnosis of dyspepsia, gastroparesis, reflux, motility disorders, pyloric dysfunction, and associated symptoms (nausea, vomiting, bloating, abdominal distension, and pain). Built on 30 years of AI development, device engineering, and medical simulation integration, the platform is FDA-approved as the only approved device for non-invasive electrogastrographic diagnosis. 3CPM markets to gastroenterology practices, hospitals, and ambulatory surgical centers, emphasizing improved patient outcomes, increased satisfaction, and positive cash flow for healthcare facilities.
Polymedco, Inc.
Polymedco is a B2B medical diagnostics company specializing in early detection and screening solutions for life-threatening diseases. The company develops and markets two primary product lines: OC-Auto® FIT, an automated fecal immunochemical test for colorectal cancer screening, and PATHFAST® Cardiac Biomarker Analyzer, a point-of-care (POC) cardiac testing platform. OC-Auto FIT is marketed as the number-one automated noninvasive CRC screening tool globally, carrying a Tier 1 US Preventive Services Task Force guideline recommendation, and has demonstrated clinical evidence of improving patient compliance (43.8% increase), reducing annual CRC incidence (25.5% reduction), and reducing cancer mortality (52.4% reduction). The PATHFAST analyzer performs lab-quality cardiac biomarker testing from a single whole blood sample, delivering results in minutes with measurements of Troponin I, NTproBNP, D-Dimer, hsCRP, CK-MB, and Myoglobin. Both systems are designed for integration into healthcare systems, reference laboratories, and point-of-care settings. Polymedco emphasizes customer-centric support, offering customizable programmatic solutions, technical implementation support, and LIS (Laboratory Information System) integration. The company partners with healthcare systems, payors, providers, and reference laboratories to improve screening accessibility and affordability. Products feature robust clinical evidence and user-friendly design for high-volume, cost-effective screening and diagnostic workflows.
Wavely Diagnostics, Inc.
Wavely Diagnostics, Inc. develops WavelyDx®, an FDA-listed Class II Exempt diagnostic device that enables parents to screen for middle ear fluid and potential ear infections at home using acoustic echography. The system consists of disposable ear tips that attach to an iPhone and a mobile application that transmits soft sound waves to detect fluid behind the eardrum. Clinical validation demonstrates 84.5% accuracy—exceeding traditional otoscope examination. WavelyDx facilitates early identification of ear infection indicators, reduces unnecessary clinic visits, and enables virtual care consultation through partnered telehealth providers. Designed for pediatric home use, the device addresses the clinical reality that only 1 in 3 ear infection clinic visits confirm positive findings, helping families make informed care decisions and avoid unnecessary antibiotic exposure.
IMVARIA Inc.
IMVARIA is a software-as-medical-device (SaMD) company that develops AI-driven digital biomarker solutions for clinical decision support, with a primary focus on non-invasive diagnosis of pulmonary and oncological diseases. Founded in 2019 by physician-engineers from Google and Stanford University, the company operates an AI Lab with automated machine-learning algorithm technology to analyze computed tomography (CT) imaging and clinical data. The company's lead FDA-authorized product, Fibresolve, received FDA De Novo marketing authorization in January 2024 as the first FDA-authorized diagnostic tool for lung fibrosis, specifically idiopathic pulmonary fibrosis (IPF). Fibresolve also holds the distinction of being the first FDA Breakthrough-Designated AI diagnostic tool with simultaneously adopted CPT billing codes by the American Medical Association. It analyzes lung CT imaging to provide diagnostic subtype classification for suspected interstitial lung disease (ILD), serving as an adjunct to clinician assessment and reducing the need for invasive biopsy testing. In January 2025, IMVARIA received FDA 510(k) clearance for ScreenDx, a screening algorithm designed to assess for interstitial lung disease findings on CT imaging. This tool assists with early identification and referral pathways for suspected ILD across diverse clinical settings including emergency departments and lung cancer screening programs. The company is also developing Bronchosolve, an investigational AI-powered diagnostic solution for assessment of suspicious pulmonary nodules in lung cancer cases. In October 2025, Bronchosolve met primary endpoints in the pivotal VIRTUAL-BRONCH Study, demonstrating improved accuracy in non-invasive lung cancer diagnosis. IMVARIA received Phase I NIH SBIR grant funding in September 2025 to extend its AI platform into oncology. IMVARIA operates a centralized service model requiring minimal workflow disruption for clinicians. The company has established clinical partnerships with Mayo Clinic and multiple U.S. medical institutions, and announced a strategic distribution partnership with Medical Horizons to expand access in the Middle East and North Africa region. All products are cloud-based, software-only solutions that integrate with existing CT imaging infrastructure.
Inflammatix
Inflammatix develops host response diagnostics that leverage immune system biomarkers to rapidly identify and classify acute infections in emergency department settings. The company's proprietary technology uses bioinformatics, machine learning, and artificial intelligence to interpret mRNA immune signatures, enabling clinicians to distinguish bacterial from viral infections and assess illness severity. TriVerity, their FDA-cleared flagship product, provides three actionable diagnostic scores: bacterial infection likelihood, viral infection likelihood, and all-cause illness severity (risk of progression to mechanical ventilation, vasopressors, or renal replacement therapy within seven days). Unlike pathogen-targeting tests, Inflammatix's approach measures circulating immune cell signatures generated by localized infections, improving sensitivity for early detection. The technology is clinically validated and addresses critical gaps in rapid, accurate triage and decision-making when certainty is limited. The company serves emergency departments and acute care settings, with regulatory clearance from the FDA and operations in the United States and Europe.
Proven Medical Testing LLC
Proven Medical Testing LLC is an FDA-registered distributor of rapid diagnostic tests and sterile surgical kits for clinical practices, urgent care centers, and physician offices. Founded by New York clinicians, the company sources point-of-care diagnostics and single-use surgical supplies directly from FDA-registered manufacturers and distributes them at transparent wholesale pricing. Product portfolio includes rapid antigen tests for influenza A & B, RSV, Strep A, and hCG pregnancy testing; sterile removal kits for staples and sutures; and IV start kits. All SKUs are FDA-registered and traceable. The company operates from a New York warehouse with same-day dispatch capability for in-stock orders placed before 2 PM ET, Monday–Friday. Free domestic shipping and international fulfillment available. Volume-tier pricing and bulk quotes offered to high-volume reorder accounts.
Cepheid
Cepheid is a molecular diagnostics company specializing in rapid, point-of-care testing systems and molecular assays. The company's flagship GeneXpert® System is a fully scalable platform offering a broad menu of diagnostic tests across infectious disease, respiratory health, gastrointestinal disorders, and other clinical areas. Their platform serves settings from core laboratories to near-patient and point-of-care applications, enabling fast turnaround results for improved clinical decision-making. Cepheid's test portfolio includes PCR-based assays for tuberculosis, respiratory infections, gastrointestinal pathogens, and healthcare-associated infections. The company markets solutions to laboratory professionals, healthcare providers, and health system administrators. Cepheid operates a Global Access Program focused on expanding diagnostic access in underserved and resource-limited regions, including support for cervical cancer screening and TB elimination initiatives. Products are designed for workflow connectivity and integration within healthcare settings. The company emphasizes rapid, accurate diagnostic results to support effective patient management and antimicrobial stewardship. Manufacturing and regulatory compliance are implied through FDA and international certifications typical of molecular diagnostic systems.
SMARTSOUND CORPORATION
Smartsound Corporation is a Seoul-based medical technology company specializing in AI-powered sound-based diagnostic solutions. Founded in 2011, the company has developed proprietary edge artificial intelligence technology that analyzes heart and lung sounds for disease diagnosis. Since 2021, Smartsound has collaborated with 12 leading Korean university hospitals to collect and analyze clinical data, securing AI diagnostic technologies capable of identifying 5 types of lung diseases and 5 types of heart diseases. The company offers a comprehensive portfolio of AI-enabled stethoscope products—including the SKEEPER R1 (hospital-grade), SKEEPER H1 (telemedicine/homecare), SKEEPER P1 (wearable patch for continuous monitoring), SM-300 (non-face-to-face telemedicine), and WITH A PET (veterinary cardiac assessment)—all featuring hardware-embedded AI, cloud data storage, Bluetooth connectivity, and telemedicine integration. Products support diagnosis, monitoring, and early detection of respiratory infections and cardiac conditions across clinical, home healthcare, and veterinary markets.
Elucid Bioimaging, Inc.
Elucid Bioimaging develops FDA-cleared cardiovascular imaging analytics software specializing in quantitative plaque assessment from coronary CT angiography (CCTA). The company's flagship product, PlaqueIQ™, employs CT Virtual Histology™ technology to characterize arterial plaque composition non-invasively, leveraging algorithms trained and validated against ground-truth histopathology. PlaqueIQ quantifies and classifies plaque morphology into calcified, non-calcified matrix, and lipid-rich necrotic core (LRNC) components, delivering patient-, vessel-, and lesion-level analysis with high correlation to ex vivo histology (r=0.87–0.99 across plaque types). The software integrates into clinical PACS workflows via DICOM-wrapped PDFs and interactive browser-based reports, enabling physicians to assess coronary and carotid atherosclerosis risk and guide medical versus interventional treatment decisions. Elucid holds FDA 510(k) clearance (K183012, December 2018) and has achieved Category I CPT coding and broad CMS reimbursement as of January 2026. The company also develops FFRCT (fractional flow reserve CT) technology under regulatory pathway. Served markets include cardiology, interventional cardiology, radiology, and cardiovascular research. Clinical validation includes partnership with CVPath Institute and peer-reviewed publications in major cardiovascular literature.
QIAGEN Sciences LLC
QIAGEN is a multinational life sciences company specializing in sample preparation, nucleic acid purification, and molecular diagnostic technologies. The company offers comprehensive solutions including consumable kits for DNA/RNA extraction, automation systems for sample processing, and advanced diagnostic platforms utilizing PCR, digital PCR (dPCR), and next-generation sequencing (NGS). QIAGEN serves diverse markets including clinical laboratories, pharmaceutical and biotech companies, academic research institutions, and organizations in forensics, food safety, and pathogen surveillance. The company provides integrated solutions spanning discovery and translational research, diagnostics and clinical research, human ID and forensics applications, and informatics and data analysis. With over 500,000 customers globally, QIAGEN delivers end-to-end workflows under its "Sample to Insight" philosophy, combining instruments, consumables, and software platforms for molecular testing and biomarker discovery.
DAXOR CORPORATION
Daxor Corporation is a medical device company founded in 1970 and headquartered in Oak Ridge, Tennessee, specializing in blood volume measurement technology. The company's flagship product, the BVA-100 Blood Volume Analyzer, is an FDA-cleared diagnostic system that uses indicator dilution technique with I-131 Human Serum Albumin to provide precise quantification of total blood volume, plasma volume, and red cell mass in adult patients. The BVA-100 calculates normalized hematocrit and albumin transudation rate, enabling clinicians to detect hidden fluid imbalances that indirect measures miss. Daxor also supplies Volumex diagnostic kits, the radiopharmaceutical component required for blood volume analysis procedures. The technology is designed for hospital laboratory settings and clinical departments requiring critical fluid management decisions, including heart failure, critical care, sepsis, ARDS, syncope, and surgical blood loss assessment. The system is reimbursed by both public and private payers for inpatient and outpatient use, with demonstrated clinical outcomes in reducing mortality and hospital readmissions.
Allergy & Applicator Depot, LLC
Allergy & Applicator Depot supplies FDA-compliant allergy diagnostic and immunotherapy products for medical practices. The company specializes in turnkey allergy testing kits, diagnostic antigen extracts, skin test applicators, and immunotherapy treatments (SLIT/SCIT). Product lines include environmental, food, and pediatric diagnostic test kits in various panel sizes (24–80 allergens), corresponding antigen extract sets for skin testing, and multi-prong applicators (8-prong and 10-prong configurations) available in bulk quantities (200–600 count cases). The company markets its offerings as cost-effective, CLIA-free solutions designed to help practices identify patient allergen triggers, generate diagnostic revenue, and offer long-term immunotherapy treatment options. Regulatory compliance includes FDA approval and CLIA exemption status. Target market comprises allergists, primary care practices, and other medical providers seeking to add allergy testing and treatment services.
BioSynchronicity Corporation
BioSynchronicity Corporation is a diagnostic test manufacturer specializing in rapid, point-of-care in vitro immunochromatographic assays for infectious disease detection. The company's primary product is the C-Sync® COVID-19 Antigen Test, an ultra-rapid qualitative assay for SARS-CoV-2 detection authorized under FDA Emergency Use Authorization (EUA220346, issued March 23, 2023). The company also develops the Stayin' Alive™ product line, including multi-drug screening tests. BioSynchronicity operates a team with expertise in technology development, healthcare delivery, and international trade, supported by state-of-the-art R&D capabilities. Manufacturing is conducted under ISO 13485 certified protocols with quality control and assurance supervision. Analytical performance testing is performed by an accredited laboratory in Rockville, Maryland. The company holds CE Mark certification for the European Union with Ministry of Health registration in The Netherlands, and has obtained a Free Sales Certificate for the UAE. BioSynchronicity is positioned to serve markets across the USA, Europe, MENA, and Africa. The company emphasizes affordable, reliable rapid diagnostic testing as a component of integrated infectious disease mitigation strategies.
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