Class III
High-risk device and includes devices that may be implanted or support life. Also, devices that are new in technology, and there is no substantially equivalent device currently available.
16 Members with Class III capabilities

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.
Arsenal Medical is dedicated to transforming medical devices with innovative biomaterials. Founded by Carmichael Roberts, Robert Langer, and George Whitesides, the company aims to address unmet medical needs through thoughtfully designed products. Their vision is to provide local therapy for important medical conditions across various therapeutic areas, leveraging expertise in materials science and chemistry.

AmacaThera is a clinical-stage biotechnology company focused on transforming therapeutics to improve patient health. Utilizing a unique injectable hydrogel platform, the company aims to provide localized, sustained drug delivery across various therapeutic areas, including post-surgical pain management and cancer treatment.

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, 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.
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.

Smith+Nephew is a portfolio medical technology company focused on the repair, regeneration, and replacement of soft and hard tissue. The company aims to restore people's bodies and their self-belief by using technology to take the limits off living. With a commitment to medical education and improving patient outcomes, Smith+Nephew operates in over 100 countries and is dedicated to sustainability and community health. Their purpose is to promote health and wellbeing, not just through their products but also by ensuring a positive impact on society and the environment. Smith+Nephew is also committed to increasing diversity within the medical device industry through initiatives like the Orthopaedics for All global advisory board.

4WEB Medical is an orthopedic implant company that specializes in developing innovative implants using its proprietary Truss Implant Technology™. This technology is designed to stimulate a mechanobiological response, facilitating fusion and improving patient outcomes. With a focus on advanced structural design, 4WEB Medical aims to enhance the healing process through its unique implant solutions.

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.

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 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 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 is dedicated to developing innovative medical devices and technologies that enhance emergency care and trauma management, particularly in military settings.

MRIGlobal is a renowned Midwest research institute based in Kansas City, dedicated to improving the overall health, safety, and well-being of people everywhere. With over 80 years of experience, MRIGlobal specializes in diagnostics, pharmaceutical sciences, vaccines and therapeutics, global health surveillance, infectious disease, public health, warfighter protection, agriculture, and management and operations. The organization is committed to using science and technology to create solutions for a safer, healthier, and more sustainable world.

ZOLL Medical Corporation, a subsidiary of Asahi Kasei, is a global leader in developing and marketing medical devices and software solutions aimed at advancing emergency care and improving patient outcomes. Founded in 1980 and named after Dr. Paul Zoll, the company is renowned for its innovative technologies in defibrillation, cardiac monitoring, and other critical care solutions. ZOLL is committed to enhancing clinical and operational efficiencies, supporting healthcare professionals and lay rescuers worldwide in addressing serious cardiopulmonary and respiratory conditions.

Automedicus Corporation, Inc. is a medical device firm that has invented and is developing a transformative blood pressure management device called AutoPress. This device aims to provide a low-cost solution for managing blood pressure volatility, which is a significant issue in various medical settings, particularly during surgeries.

MedTech Innovator is the world's largest accelerator for medical device, digital health, and diagnostic companies. Their mission is to improve patients' lives by accelerating the growth of companies transforming healthcare worldwide. They offer programs and resources to support innovators in the medtech industry, including webinars, fellowships, and strategic partnerships.

Manufacture of a Settable Polymer Composite Bone Graft to Stabilize Fractures
Open fracture injuries are one of the largest sources of morbidity on both the battlefield and in the civilian population. The design of biomaterials that mechanically stabilize fractures while remodeling to form new bone is an unmet challenge in bone tissue engineering. Vanderbilt has designed a new bone void filler that induces bone growth, provides bone-like mechanical properties, and undergoes resorption at a rate aligned with patient biology.
Critical Innovations LLC
BurRapid Epidural Drainage Attachment for Traumatic Brain Injury
Epidural bleeding from traumatic brain injury (TBI) is immediately life-threatening and can quickly lead to brain herniation and death unless there is immediate neurosurgical intervention. BurRapid™, developed by Critical Innovations, is a medical device that provides hematoma drainage and intracranial pressure monitoring to sustain TBI patients on the battlefield. This allows for provision of these life-saving interventions earlier in the roles of care, including at the point-of-injury.
University of Colorado, Denver Center for Combat Medicine and Battlefield (COMBAT) Research
Community-Engaged Research Shows Promise for Adapting Safety Interventions in Military Populations
Researchers at the University of Colorado Anschutz, supported by MOMRP and MTEC, adapted the Project Safe Guard (PSG) intervention for military populations, emphasizing peer discussions and addressing implementation challenges.
Potential for Early Covid-19 detection using Fitbit devices
Early detection of COVID-19 is a critical force readiness issue for the U.S. Armed Forces. Thus, there is an urgent need to develop wearable diagnostics to identify COVID-19 cases. Fitbit is currently working to further validate its COVID-19 algorithm through a prospective study with Northwell Health utilizing Fitbit Sense and Versa 3 smartwatches. The hope is to bring wearable illness detection capabilities to its users.