FDA Regulated Medical Devices

Devices reviewed and monitored by the FDA for safety and efficacy.

45 Members with FDA Regulated Medical Devices 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.

Arsenal Medical
Arsenal Medical

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.

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.

AmacaThera
AmacaThera

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
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.

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.

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.

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.

Smith+Nephew
Smith+Nephew

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
4WEB Medical

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
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.

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.

We are here to help

Can’t find what you’re looking for?

Projects

Technology Showcase

See All Projects

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.