Class I

Low-risk Devices with minimal safety considerations

44 Members with Class I capabilities

Humanetics Corporation
Humanetics Corporation

Humanetics Corporation is a clinical-stage pharmaceutical company based in Minneapolis, Minnesota, focused on developing and commercializing products to enhance human health and wellbeing. Founded in 1988, the company specializes in radiation modulators, adjunctive oncology therapies, and pulmonary protective therapies, particularly for COVID-19. Humanetics is known for its lead drug candidate, BIO 300, which is being developed as a radioprotectant for military and civilian use, as well as a treatment to improve outcomes in cancer patients receiving radiotherapy. The company is actively engaged in research programs for non-small cell lung cancer, prostate cancer, and head and neck cancers.

Altra Inc.
Altra Inc.

Altra Inc. is at the forefront of revolutionizing infusion therapy with its innovative Altra Infusion System. The company is dedicated to addressing the critical challenges in the infusion industry, such as mechanical failures, flow issues, and false alarms, which contribute to a significant portion of medication errors and adverse drug events. Altra's mission is to ensure patient safety and improve healthcare delivery through advanced technology solutions.

Action Medical Technologies
Action Medical Technologies

Action Medical Technologies is a pharmaceutical and medical device company focused on developing innovative solutions that integrate medications with advanced devices and injector systems to improve patient outcomes, particularly in austere prehospital environments.

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.

PinMed, Inc.
PinMed, Inc.

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.

Ease Healthcare
Ease Healthcare

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
Exponent

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.

Purgo Scientific
Purgo Scientific

Purgo Scientific is a medical device company dedicated to developing effective solutions for the biofilm infections crisis in orthopedic surgery. Their mission is to provide a locally targeted sustained delivery device that ensures the right therapy is delivered to the right place for the right duration, ultimately improving patient outcomes and reducing the impact of surgical site infections.

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.

Prolucid Technologies Inc.
Prolucid Technologies Inc.

Prolucid Technologies Inc. specializes in custom software development for highly regulated industries, including medical and nuclear sectors. With over 17 years of experience and more than 1200 projects completed, Prolucid delivers robust, secure, and compliant software solutions. The company is ISO 13485 certified for medical software and adheres to CSA N299.1 and ISO 9001 standards for nuclear applications. Prolucid offers end-to-end services from project definition and planning to design, development, verification, and ongoing support, leveraging advanced technologies such as AI, ML, computer vision, and cloud infrastructure.

Profusa, Inc.
Profusa, Inc.

Profusa, Inc. is a pioneering digital health company based in the San Francisco Bay Area, dedicated to making the body’s chemistry easily accessible to improve health and wellness. Profusa develops tissue-integrating biosensors for continuous, real-time monitoring of body chemistries, empowering individuals and clinicians with actionable, medical-grade data to transform personal health management and disease prevention. Their unique bioengineering approach overcomes the foreign body response, enabling long-term, in-body monitoring through tiny, flexible biosensors that become one with the body. Profusa’s technology platform supports both consumer and medical applications, with a vision to revolutionize personalized medicine and digital health. The company is supported by significant grant funding from agencies such as DARPA and NIH, and collaborates with leading academic, hospital, and industry partners worldwide.

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.

Solventum
Solventum

Solventum is a healthcare company dedicated to enabling better, smarter, and safer healthcare solutions. With a legacy of innovation, Solventum focuses on improving patient outcomes through advanced medical technologies, oral care solutions, health information technology, and purification and filtration systems.

Cogwear
Cogwear

Cogwear is a US-based neurotechnology company specializing in wearable EEG devices that deliver clinical-grade brain monitoring and analytics outside traditional laboratory or clinical environments. Founded in collaboration with academic neuroscience experts and supported by organizations such as the National Science Foundation, Cogwear's mission is to provide scalable, real-time cognitive and mental health insights for medical, athletic, research, and commercial settings. Their technology platform employs advanced dry EEG sensors and machine learning algorithms for applications including early detection of Alzheimer's disease, behavioral health assessment, concussion monitoring, and neuromarketing analytics. The company is committed to meeting FDA requirements for medical-grade devices while expanding its impact through industry partnerships and scalable manufacturing.

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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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