Class II

Intermediate-risk device that is subject to "special controls" to assure safety.

34 Members with Class II capabilities

Volatylix, Inc
Volatylix, Inc

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 Pharma
FiteBac Pharma

FiteBac Technology/FiteBac Pharma's 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. FiteBac K21 uniquely targets the underlying disease state, given that most diseases involve microbial-associated inflammation and mitochondrial dysfunction.

Qidni Labs
Qidni Labs

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.

Bessel
Bessel

Bessel's mission is to deliver breakthroughs that scale by empowering medtech startups and teams. Bessel provides comprehensive strategy, execution, and fundraising support from initial concept to commercial release. The company is committed to fostering innovation and high-performance teams through its various programs, including the Powered by Bessel accelerator, Bessel Origin learning laboratory, and Bessel Rapid Innovation consulting services.

Sana Health
Sana Health

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
Ease Healthcare

Ease Healthcare, a registered DBA of MPS Medical, Inc., is a leading distributor and commercialization partner for clinically validated diagnostic tools, monitoring devices, and health and wellness technologies. The company is dedicated to enabling proactive healthcare decisions and equipping providers, organizations, and individuals with advanced solutions for early detection, timely intervention, and improved patient outcomes. With a mission to make advanced science and technology accessible to all, Ease Healthcare focuses on expanding access to effective solutions for major health challenges, including cancer, cardiovascular disease, and infectious conditions. Their vision centers on breaking barriers in healthcare by making innovative medical solutions affordable, accessible, and easy to use for individuals, providers, and communities, regardless of economic or geographic barriers. Ease Healthcare also offers turnkey services for medical device manufacturing and distribution, supporting partners from product development through regulatory compliance and market entry.

PPD
PPD

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
Simbex

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, Inc.
Limax Biosciences, Inc.

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.

Via Product Development
Via Product Development

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
Pneuma Systems Corporation

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
CorNeat Vision

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
Predicate AI Labs

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.

Alira Health
Alira Health

Alira Health is a global consulting and clinical services company that aims to humanize healthcare and life sciences through innovative technologies and expert guidance. They focus on improving patient outcomes by integrating patient voices into the development of treatments and enhancing care quality across the healthcare ecosystem.

Aerstone
Aerstone

Aerstone is a cybersecurity firm dedicated to elevating businesses beyond the security status quo. With a focus on personalized cybersecurity solutions, Aerstone prioritizes understanding the unique needs and challenges of each client. The company is NSA-certified and boasts over 20 years of experience in the field, offering a boutique approach to cybersecurity that emphasizes quality over quantity. Aerstone's mission is to secure the digital world, one client at a time, by providing tailored strategies that deliver maximum impact. Aerstone's security architecture services are designed to fortify digital landscapes, safeguard assets, and keep organizations ahead of evolving threats, ensuring compliance and business continuity.

Critical Innovations LLC
Critical Innovations LLC

Critical Innovations LLC is a medical research and development company focused on creating cutting-edge solutions to health threats across pre-hospital, hospital, and military environments. The company focuses on task-shifting evidence-based interventions to earlier echelons of care and more general specialty levels, to simplify management and allow for rapid provision in emergency and combat environments. The company is dedicated to developing innovative medical devices and technologies that enhance emergency care and trauma management, particularly in military settings.

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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.

BiomX

BiomX Achieves Positive Phase 2 Results for BX211 in Treating Diabetic Foot Osteomyelitis

BiomX has reported positive Phase 2 results for BX211, its personalized phage therapy for Diabetic Foot Osteomyelitis (DFO). The treatment significantly improved ulcer healing, showing promise for reducing amputation risk. Supported by NMRC and MTEC, BX211 may offer new hope for both military and civilian patients.

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