Class II
Intermediate-risk device that is subject to "special controls" to assure safety.
42 Members with Class II capabilities

Volatylix, a Cambridge, MA based startup, is dedicated to early diagnosis enabling timely and appropriate treatment benefiting the patient, physician, provider and payor. Our patent pending platform – DECIPHER – and unique detection sensor technology – OFIS - combine to identify various disease states and conditions via proprietary breath biomarkers, volatile organic compounds (VOC’s). DECIPHER is disease agnostic and will speed diagnosis, while improving accuracy over currently available diagnostic methods. The tests use a noninvasive 4-minute breath sample with analysis taking ~15 minutes on our portable, battery powered platform. Initial products include fungal pneumonias, lung cancer (staging, monitoring, differential diagnosis and screening) and C. difficile.

FiteBac Technology/FiteBac Pharma's K21 uniquely targets the underlying disease state, given that most diseases involve microbial-associated inflammation and mitochondrial dysfunction. FiteBac Technology innovations stem from the work of numerous international academic research scientists. FiteBac Pharma K21 is the blockbuster antimicrobial small molecule designed to modulate biological, immunological, and metabolic systems for treating a wide range of infectious and inflammatory diseases. This patented drug substance has demonstrated the ability to safely eliminate bacterial, fungal, and viral infections, enhance innate immunity, induce mitophagy while improving mitochondrial and cellular metabolism, accelerate wound healing, and even promote the development of zebrafish and chickens, leading to increased adult mass. Rigorous research from Dr. Bhupesh Prusty's laboratory and Dr Christopher Rongo's laboratory is focused on various aspects of mitochondrial remodeling and reprograming, as well as mitochondrial-to-nuclear signaling with K21.

Qidni Labs is a NATO DIANA company recognized by Fast Company as a 2025 World Changing Idea. The company has developed a portable, nearly waterless hemodialysis system that will make treatment accessible for over 10 million patients every year.

From Rapid Innovation to Breakthrough Impact, Bessel Helps Startups and Scaling Teams Move Faster, Smarter, and Together with Fewer Missteps. Experience Bessel Rapid Innovation: We embed with your team to rescue stalled projects or fill critical gaps. From R&D to Quality Systems to Regulatory Affairs, we drive rapid progress to reduce your burn rate and improve profitability. We help your team deliver measurable results: reduced COGS, decreased complaints, improved performance. Our Powered by Bessel™ Accelerator is an Intensive, fixed-duration programs to refine your technology strategy, align teams, and prepare for fundraising—perfect for startups seeking clarity and velocity. Save months in development, find your sweet spot with investors, build and support your team. The Bessel Origin™ workforce development program, born in the classroom, trains emerging medtech teams in design thinking and agile teamwork, fueling innovation. Boost team performance and identify, develop, and retain your emerging leaders.

PinMed, Inc., is a National Innovation Award-winning bioinformatics/medical-device company that develops high-fidelity cardiovascular monitoring systems, personalized (adaptive) software, and integrated systems and custom solutions for tracking cardiovascular data in the most challenging environments (e.g., intensive activity, extreme electromagnetic interference, and interventional cardiovascular procedures) and identifying subtle but clinically important indicators of cardiovascular events. PinMed’s award-winning solutions include versatile, multisensor, high-fidelity monitoring systems for various hospital and ambulatory settings. The company has extensive experience in electronic and mechanical engineering, development of software and firmware for various processors, computational modeling, and cardiovascular physiology. PinMed’s flagship mobile platform, PELEX, provides unparalleled versatility in physiological monitoring and has been cleared by the FDA for diagnostic 12-lead ECG testing and various types of ambulatory monitoring.

Military Operational Medicine funded for PTSD, Adjustment Disorder and Pain and Sleep (over $5m). 3 trials in progress. Sana Health is an FDA Breakthrough Designated Device, currently in front of the FDA for Neuropathic Pain as a de novo - expecting to be on market Q4 2025. Sana is a wearable audiovisual neuromodulation device, that provides anxiety and pain relief, and sleep on demand. $25m raised to date, and in the middle of a Series A extension SAFE note round.

Ease Healthcare (a registered DBA of MPS Medical, Inc.) is committed to advancing next-generation military medicine by accelerating access to clinically validated diagnostic tools, monitoring devices, and health and wellness technologies. As a trusted commercialization partner and distributor, the company empowers providers, organizations, and individuals with advanced solutions that support early detection, timely intervention, and improved health outcomes in both civilian and military settings. With a mission to make cutting-edge science and technology accessible to all, Ease Healthcare focuses on addressing critical health challenges such as 02 delivery, cancer, and cardiovascular disease —areas that directly impact force readiness and resilience. The company’s vision is to break barriers in healthcare by delivering innovative medical solutions that are affordable, accessible, and simple to use, regardless of economic or geographic limitations. In addition to bringing transformative technologies to market, Ease Healthcare provides turnkey services for medical device manufacturing and distribution, guiding partners from product development through regulatory compliance and successful deployment. By combining technical expertise with a dedication to accessibility, Ease Healthcare supports the Department of Defense’s priorities in preparing and protecting service members with next-generation healthcare solutions.
Exponent is a multidisciplinary science and engineering consulting firm serving sectors including healthcare, energy, manufacturing, and consumer products. The firm offers technical, regulatory, and risk management expertise supporting clients across the product lifecycle, with capabilities in advanced analytical modeling, laboratory and field testing, product safety, failure analysis, and regulatory compliance. Exponent's professionals contribute peer-reviewed research and leadership to major scientific and engineering forums.

PPD, a clinical research business of Thermo Fisher Scientific, is a leading provider of global contract research organization (CRO) solutions. The company is dedicated to helping clients accelerate the development of life-changing therapies through comprehensive drug development, laboratory, and lifecycle services. With a commitment to operational excellence and innovative technology, PPD empowers its customers to bring therapies to market faster and improve patient health. PPD has been recognized as an industry leader in clinical development digital transformation services and patient engagement digital transformation. With over 30 years of clinical leadership and a workforce of more than 30,000 employees globally, PPD has conducted over 2,100 trials in the past five years.

Simbex is a leading partner in medical device and consumer health product design and development, recognized for transforming complex ideas into commercially successful solutions. With a multidisciplinary team, Simbex excels in engineering, product design, software, data analytics, and commercialization strategy, supporting innovators from concept to market. Their mission is to deliver impactful medical devices and consumer health products that improve health outcomes and quality of life. Simbex is known for its holistic approach, deep regulatory expertise, and commitment to innovation and excellence in the health technology sector. The company is also active in thought leadership, regularly publishing regulatory and reimbursement updates, and hosting educational webinars for the MedTech community. Simbex maintains a robust Quality Management System compliant with ISO 13485 and FDA 21 CFR 820, ensuring high standards in product development. The company is also committed to supporting diversity in MedTech, including initiatives for women in the sector. Simbex's leadership and advisory team bring decades of experience in biomedical engineering, commercialization, regulatory affairs, and technology innovation, further strengthening its position as a trusted partner in the MedTech ecosystem.

Limax Biosciences is dedicated to revolutionizing tissue healing through innovative biomaterials inspired by the natural slime of slugs. Their hydrogels provide superior adhesion and healing capabilities, addressing unmet medical needs both inside and outside the body.

Makani Science, Inc. is dedicated to transforming respiratory care by making respiratory monitoring more accessible, accurate, and comfortable. Originating from over a decade of research at the University of California, Irvine, the company was founded to address the critical need for reliable breathing monitoring in clinical and home settings. Their mission is to improve patient health by providing healthcare professionals and patients with better data, enabling earlier detection of respiratory issues, and enhancing quality of life through advanced biofeedback and wellness applications.

Via Product Development (Via PD) helps turn ambitious visions into successful products by providing expert guidance throughout the entire product development lifecycle. We specialize in electronics design and development, helping clients navigate from initial concept through to manufacturing. With a focus on clear communication, strategic planning, and technical excellence, we help teams reduce risk and accelerate timelines. We leverage deep industry expertise and strong partnerships to ensure optimal product-market fit and successful commercialization, particularly in highly regulated and technically complex sectors.

Pneuma Systems Corporation specializes in designing and licensing closed-loop fluid control systems that precisely manage small fluid volumes without the complexity of traditional pumping mechanisms. The company leverages over 30 inventions and three novel subsystems to revolutionize fluid flow, workflow, information flow, and cash flow, aiming to transform the standard of care in infusion therapy. Pneuma is a small team of experienced medical device professionals working on a new technology platform for precise fluid delivery, with an emphasis on infusion therapy. Armed with a strong IP portfolio, Pneuma’s infusion controller is designed to support all venues of infusion therapy including acute care, standalone infusion centers, and home care. The design offers significant advances in fluid flow, information flow, and work flow. The design has been accepted into an accelerated review program by the U.S. Food and Drug Administration (FDA), known as STeP.

CorNeat Vision is dedicated to developing innovative biomimetic medical solutions aimed at addressing unmet medical needs across various therapeutic fields. Their mission is to harness biomimicry to improve health and equality worldwide, focusing on creating permanent, synthetic implants that integrate seamlessly with human tissue.

Predicate AI Labs is advancing the future of healthcare diagnostics as the developer of OpenDx™, a clinical surveillance platform that anticipates — not just detects — patient deterioration. By fusing wearable sensor data with voice analysis (semantics and vocal biomarkers), Predicate is redefining early warning systems to support earlier intervention, improve outcomes, and extend advanced surveillance capabilities to low-resource, austere, and military care settings.

Theradaptive
Theradaptive’s RESTORE Trial Initiation for OsteoAdapt™ DE
Theradaptive launches RESTORE Phase I/II trial of OsteoAdapt™ DE for faster, precision bone healing in craniofacial injuries. MTEC-funded study targets improved recovery for military and civilian patients.
Altec
Autonomous Rehabilitation Device for Improved Recovery in Warfighters
The OSCIR platform—developed by Altec Inc in collaboration with the Naval Health Research Center—is bringing clinical-grade, real-time movement analysis to the front lines. Funded under MTEC-22-02-MPAI
Medical Technology Enterprise Consortium (MTEC)
The Power of IP: Why It Matters to MTEC and Our Mission
MTEC President highlights intellectual property as essential to protecting innovation, attracting investment, and enabling collaboration. A new partnership with Patenter.io supports members in managing and commercializing IP.
George Mason University
SMART-US Wearable Ultrasound + AI Device for Muscle Force Prediction
AI-powered ultrasound in a wearable—SMART-US delivers lab-grade muscle-force insights anywhere.