FDA Regulated Medical Devices

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.

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.

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.

STAT Therapeutics is focused on developing a drug- device combination for easy, rapid administration of intramuscular, life-saving medications by users in any setting, aiming to improve access and usability for acute emergency treatments such as pain, anaphylaxis, and seizures.

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 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 helps medtech startups and scaling teams move faster with hands-on support across R&D, marketing, quality, regulatory readiness, product development, manufacturing transfer, commercialization, fundraising readiness, and high-performance team execution. From Rapid Innovation to Breakthrough Impact, Bessel helps startups and commercially scaling teams build better and deliver faster with Bessel's AI Teammate for high-performance blended human + AI teams. 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 program 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.

Harmac is a global contract design and manufacturing organization specializing in single-use medical devices. With over four decades of experience, Harmac provides comprehensive services including product design and development, advanced manufacturing, automation, value engineering, quality assurance, and packaging and sterilization. The company is known for its operational excellence, regulatory compliance, and commitment to sustainability and community engagement. Harmac operates facilities across the United States, Ireland, and Mexico, supporting customers worldwide and across a range of clinical applications. ISO 13485 Certified and FDA Registered.

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.

Evimero is an interdisciplinary company focused on understanding the interactions between microorganisms and human health, agriculture, and the environment, utilizing Systems Biology and AI/ML. Evimero applies molecular principles to infectious disease and microbiome science to improve health outcomes and environmental sustainability through targeted interventions in dysbiotic microbiomes and in people with infectious disorders. Evimero has an infectious disease product pipeline including both prophylactic and diagnostic assets against common causes of Travelers' Diarrhea, including a unique approach to preventing infection with human Norovirus, enterotoxigenic E. coli (ETEC) and others. Evimero's pipeline of drugs targeting human and animal microbiomes includes early-stage assets aimed at generalized microbiome-driven inflammation and gut leak, and specific disease-targeted disorders including Parkinson Disease and Inflammatory Bowel Diseases. Evimero's platform also makes possible a suite of point-of-care diagnostics that can be used for patient cohorting (infectious diseases), risk stratification, and ultimately informing therapeutic decision-making. The nature of Evimero's platform assures a steady stream of novel assets targeting both infectious diseases and chronic disorders with roots in microbiome dysfunction.

ExcelCoat Technologies, Inc., based in Frederick, Maryland, is an emerging biotechnology company. It is developing novel medical devices to improve wound healing with proprietary atmospheric non-thermal plasma technology. The reactive plasma species generated in the non-thermal plasma can be optimized to effectively disinfect bacteria to prevent delayed healing, and at the same time stimulate epithelial cell migration and proliferation. This novel device will be used by care providers in clinic settings to treat wounds without causing pain to the patient. The company also holds a US patent on biocompatible nanocoating, which can be applied onto cardiovascular stents to prevent both in-stent restenosis and thrombosis.

RBT Resources is a service-disabled veteran-owned medical device company focused on rapidly improving damage-control resuscitation and blood delivery in austere, prehospital, and mass-casualty environments. The company is developing a next-generation rapid blood transfusion platform that leverages a compact, reusable pump and mission-configurable disposables to enable faster, more controlled administration of whole blood and blood products at the point of injury. Founded by former U.S. Special Operations Forces operators, RBT Resources is dedicated to closing critical medical capability gaps observed in combat through user-driven design and close collaboration with military medical teams. ​

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. From medical devices, pharmaceuticals, and supplements to digital health and wearables, we deliver rigorous science that quantifies impacts on human health. Exponent helps you push the envelope on the development, deployment, safety, and effectiveness of cutting-edge drugs, devices, and diagnostics — concomitantly balancing benefits and risks. Count on our multidisciplinary, data-driven, evidence-based assessments to give you clarity on your most complex product needs and challenges. With lives on the line, innovations that support healthcare demand the highest levels of scientific rigor. Whether you’re developing a novel drug, a sturdier stent, or a faster flu test, you need clear answers to complex questions, quickly. Exponent supports our life sciences clients across the total product lifecycle by solving critical design, regulatory, safety, and market access challenges. We can collaborate with you throughout your journey, helping you navigate risks and opportunities — and optimize outcomes — with science-based strategies and specialized expertise.

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.

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.

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.

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.

FreMon Scientific develops biomedical platforms focused on dry, electronically controlled thawing of blood, plasma, and cell therapy products. Its core solutions include portable thawing devices and disposable thermal sleeves for optimized, contamination-reduced, and traceable thawing workflows. The systems are validated for regulatory compliance, supported by clinical studies, and utilized in hospitals, laboratories, and production settings globally.

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 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 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 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.

VETRUN LLC is intentionally structured as a lean, project-focused organization designed to deliver complex, regulated medical products with speed, accountability, and cost efficiency. Rather than maintaining large internal departments for legal, regulatory, testing, manufacturing, and specialized engineering functions, VETRUN utilizes a distributed execution model, contracting with best-in-class service providers as required by each program. VETRUN works exclusively on one project at a time, enabling full leadership focus, rapid decision-making, and disciplined execution without competing internal priorities. This model allows VETRUN to assemble a tailored team of subject matter experts for each program, including legal counsel, FDA regulatory consultants, accredited testing laboratories, industry experts, contract manufacturers, and design and development partners. These relationships are not ad hoc. VETRUN has curated a robust network of U.S.-based (“Made in USA”) companies over more than 20 years, selecting partners with demonstrated experience in FDA-regulated medical devices, government programs, and high-reliability manufacturing. This long-standing network enables VETRUN to rapidly mobilize proven resources, scale capabilities as needed, and replace or augment services without disruption. By avoiding fixed overhead associated with large permanent staff and facilities, VETRUN maintains low indirect costs while preserving access to deep technical and regulatory expertise. This structure enhances flexibility, reduces financial risk, and allows resources to be applied directly to execution and milestone achievement rather than administrative burden. This execution model results in a company that is fast-moving, adaptable, and highly responsive, well-suited for time-sensitive programs requiring regulatory rigor, domestic manufacturing, and close coordination with Government stakeholders. VETRUN’s role is to serve as the integrator and accountable authority, ensuring that all partners operate cohesively toward a common objective while maintaining schedule discipline, quality compliance, and mission focus.

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.

The company develops ultra-compact, prefilled syringe technology aimed at improving efficiency, safety, and scalability in injectable drug delivery. By fundamentally reengineering syringe architecture, the platform reduces device size, simplifies logistics, reduces waste, and enhances dose accuracy and safety. The technology targets both large-scale pharmaceutical manufacturing and distribution programs, particularly addressing bottlenecks in storage, cold chain transport, and rapid response for global healthcare delivery.

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.

CellBios is a biotechnology company specializing in the design, development, and manufacturing of single-use bioprocessing and medical device solutions for healthcare, biotechnology, and regenerative medicine sectors. The company operates GMP and ISO-certified cleanroom facilities, offering a comprehensive portfolio of cryopreservation products, bioreactors, fluid management systems, advanced packaging, and specialty devices. By leveraging expertise in extrusion, molding, assembly, sterilization, quality control, and regulatory compliance, CellBios provides customized, scalable solutions to support blood transfusion, cell and gene therapy, biologics manufacturing, and clinical workflows.

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.

The University City Science Center (the Science Center) is a 501(c)3 non-profit organization based in Philadelphia, PA. The Science Center catalyzes innovation to maintain the technological superiority of the American military and the strength of the American economy. The Science Center’s core activities include programming to support and train entrepreneurs, commercialize dual use technologies, expand available capital for high growth firms, and cultivate the domestic STEM talent pipeline. We empower early-stage companies to secure and manage federal funding through specialized assistance. By leveraging our government relationships, providing comprehensive proposal development, and deploying sophisticated award management, the Science Center streamlines the process for startups in accessing federal funding. By ensuring that American scientific and technological innovations are rapidly advanced and integrated into defense and dual-use applications, the Science Center strengthens the US industrial base, enhances military readiness, and safeguards national security interests. This lab-to-market pipeline is critical to maintaining technological overmatch, securing supply chain resilience, and reinforcing biosecurity infrastructure. The Science Center’s innovation acceleration initiatives can directly contribute to the Department of Defense’s modernization priorities by reducing reliance on foreign technologies, fostering high-growth industries in critical technology areas, and ensuring that STEM advancements serve as strategic assets to protect and advance US interests. Since its founding, the Science Center’s commercialization and small business programming efforts have supported more than 700 companies, leading to 29,100 jobs with an average salary of $105,000 and $7.6 billion in annual economic impact in Greater Philadelphia. Through its commercialization programs, the Science Center has supported a range of mission-critical innovations that align with DoD priorities, including warfighter readiness, medical technology advancement, and operational resilience.

Articulate Labs aims to expand physical therapy standards and improve patient outcomes through wearable medical devices. The company uses innovative, agile technology to develop devices that make physical rehabilitation more mobile, convenient, and effective. By integrating technology with everyday activity, Articulate Labs believes patients can conquer functional limitations and better restore physical mobility.

Bench in a Box Technologies develops point-of-care diagnostic platforms tailored for field and low-resource environments. The company's core technology, Protein Signal Amplification (PSA), allows rapid, electricity-free molecular detection at room temperature, delivering results in five minutes or less, without the need for refrigeration or specialized laboratory infrastructure. Drawing on extensive expertise in molecular diagnostics, drug development, and logistics, the company aims to make high-quality diagnostics broadly accessible.

Southwest Research Institute (SwRI) is a nonprofit research and development organization that provides independent, premier services to government and industry clients. Founded in 1947, SwRI is committed to advancing science and technology to benefit humanity, focusing on innovative solutions that improve human health and safety. With a diverse range of technical divisions, SwRI addresses complex challenges in various fields including mechanical engineering, materials, aerospace, automotive, biomedical, and more.

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.

ARMR Systems, Inc. is dedicated to revolutionizing trauma care by engineering simple solutions to complex challenges. The company focuses on creating hemorrhage control systems that enhance the survivability of traumatic pre-hospital injuries, especially in situations where advanced medical help is not immediately available. Their mission is to democratize access to care and empower first responders, ensuring that anyone, regardless of their location or background, can confidently respond to emergencies. ARMR Systems champions a new approach to trauma care and preparedness, aiming to replace barriers to access with systems of equity.

ANT5 Co., Ltd. is a startup originating from Yamaguchi University dedicated to the research and development of medical devices for patients suffering from severe brain diseases. The company aims to save lives and alleviate suffering through advanced technology, with a vision to become the global standard in sensor and cooling technology for brain disease treatment by 2030.

Singletto is a biotechnology company revolutionizing antimicrobial protection for healthcare, military, industry, and consumer applications. Their core technology, Oxafence®, leverages Antimicrobial Photodynamic Inactivation (aPDI) using light-activated dyes to generate singlet oxygen, which inactivates viruses and bacteria on treated surfaces. Founded during the COVID-19 pandemic by Drs. James Chen and Thomas Lendvay, Singletto's mission is to deliver ongoing, science-driven Active Protection™ against current and emerging biological threats. The company collaborates with global health leaders, including the WHO and CDC, and partners with manufacturers to develop and commercialize innovative products that actively destroy pathogens during use. Singletto's work is validated by a robust body of peer-reviewed research and ongoing global collaborations.

Versiti is a nonprofit, 501(c)(3) blood health organization dedicated to improving patient lives and supporting healthcare partners through blood donation, innovative research, and advanced diagnostic testing. With locations across the Midwest, Versiti is a leader in blood health innovation, organ and tissue donation, and precision medicine. The organization is committed to enhancing patient care, advancing healthcare standards, and fostering a vibrant donor community. Versiti also supports education through scholarships and is recognized for its compliance and accreditations.

CRG Defense is a secure, scalable defense company, purpose-built for rapid deployment of defense and dual-use technologies into field-ready systems. From prototype to production — CRG Defense delivers mission-critical innovation across systems, materials, power, infrastructure, and medtech. Our Vision is a world where advanced defense capabilities strengthen national security, empower warfighters, and preserve freedom through innovation. Our Mission is to design, develop, and deliver solutions that serve the warfighter, support our partners, and scale to meet the future of national defense. Our Technology Innovation Division develops solutions in advanced aerospace, materials, AI, energy systems, and human health technologies, transforming emerging science into mission-ready capabilities.

ClearCure Biosciences is a clinical-stage biopharmaceutical company focused on developing non-toxic, first-in-class and best-in-class therapies for cancer, infectious diseases, sepsis, neurological diseases, and cardiovascular conditions. The company emphasizes drugging challenging targets, leveraging proprietary small molecules, nanotechnology, new oncology cell therapies, new transdermal drug delivery technology, AI and omics-driven approaches, and digital health solutions to address serious unmet medical needs. The company is currently seeking collaborators and partnerships.

Modulim is dedicated to preventing the complications of chronic wounds due to diabetes, peripheral arterial disease, and burns. Mapping tissue health at the point-of-care is key to preventing non-healing chronic wounds. This is made possible only by Modulim's handheld microvascular imaging solution, powered by Spatial Frequency Domain Imaging (SFDI), that empowers healthcare teams with proprietary data and proactive, personalized AI insights.

Vivonics, Inc. is dedicated to creating innovative solutions to address unmet medical and wellness needs, focusing on mobile physiological monitoring, advanced diagnostics, non-invasive interventions, and clinical decision support technologies. Founded in 2012, the company collaborates with a network of clinical and academic partners to enhance human health and performance in various challenging environments.

Red Maple LifeSciences develops smart biomaterial solutions designed to improve the detection and treatment of wound infections by integrating bacteria-responsive hydrogels that enable real-time infection monitoring and targeted antimicrobial therapy.

PyrAmes is a digital health company focused on transforming healthcare delivery through advanced sensor measurement. The company is developing a proprietary platform for continuous, accurate, wireless, and non-invasive blood pressure monitoring for patients of all ages, from newborns to seniors. PyrAmes aims to make blood pressure monitoring easy, low-cost, unobtrusive, and painless, ultimately improving patient outcomes.

Cohesys is a clinical-stage company focused on innovating fracture repair solutions. Its product, BoneTape, is the first bone fixation device that does not require drilling into healthy bone. The company aims to disrupt the traditional surgical-repair industry that relies on invasive plates and screws.

Reinvent Health LLC is a U.S.-based medtech company focused on early-stage R&D of scalable, clinically impactful solutions that improve patient care, streamline clinician workflows, and enhance long-term outcomes. At the intersection of clinical insight, engineering design, and translational science, Reinvent Health rapidly prototypes and tests novel technologies to address unmet needs. The company specializes in platform-oriented innovation, technology transfer, and commercial translation through licensing, spinouts, and strategic partnerships. As part of the Tettron Holdings portfolio, Reinvent Health emphasizes device-agnostic, software-driven systems with real-world usability across both hospital and field environments.

Vitls is dedicated to transforming patient care through continuous, wireless monitoring technology. Their mission is to provide peace of mind to patients, nurses, and physicians by enabling 24/7 monitoring of vital signs with unobtrusive, wearable medical devices. By pairing their devices with cloud-based data analysis, Vitls empowers healthcare professionals to make quick, informed decisions, improving patient outcomes and reducing delays in care.

Glaive Medical Optics, Inc. develops advanced intraocular lens technologies aimed at restoring vision for individuals affected by macular diseases that cause blindness. The company leverages innovation in ophthalmology and interdisciplinary expertise across optics, engineering, and materials science to deliver transformative therapies enabling patients to regain sight.

Hemerus Medical, LLC specializes in designing and developing innovative blood collection, processing, preservation, and storage technologies. Our mission is to improve patient transfusion outcomes and ensure the availability of high-quality, life-saving blood products. Hemerus aims to extend the shelf life of blood products and enhance transfusion safety through advanced technologies like leukocyte reduction filters and novel anticoagulant and additive solutions.

Surgical Magic develops real-time, AI-driven prediction systems for stroke risk. Using advanced algorithms and standard monitoring inputs, the technology predicts stroke events potentially minutes before they occur, enabling physicians to take preventative actions and improve patient outcomes. The company emphasizes validation and regulatory compliance through multi-site clinical trials and aims to advance operating rooms from reactive to predictive care.

OsteoCure Therapeutics, a Duke University spinout and Johnson & Johnson JLABS company based in Durham, North Carolina, is developing OCTA1, a first-in-class injectable therapy designed to accelerate bone healing while simultaneously reducing pain. OCTA1 is a device led combination product that is composed of a hyaluronic acid scaffold with sustained-release microgels that deliver adenosine, a naturally occurring molecule critical for bone regeneration and pain modulation. Preclinical studies have demonstrated significant improvements in fracture healing and functional recovery, with strong statistical significance in both bone repair and analgesia. For civilian medicine, OCTA1 offers a minimally invasive, opioid-sparing solution for treating fusions, fractures, and other orthopedic trauma, enabling faster recovery for patients from athletes to older adults. In military medicine, the technology addresses critical needs in combat casualty care and training-related musculoskeletal injuries such as stress fractures, by providing a deployable, shelf-stable, and rapidly administered intervention that improves healing outcomes and reduces downtime, ultimately enhancing force readiness while also benefiting the long-term musculoskeletal health of veterans

Reliable Systems Engineering, LLC is a consulting firm specializing in systems engineering for the medical device industry. The company supports clients—particularly startups, contract developers, OEMs, and CMOs—through expertise in system architecture, requirements development, risk management, verification, and cross-functional coordination. Its mission is to bring clarity, structure, and guidance to complex device development, ensuring regulatory compliance and efficient progress through disciplined engineering practices, all rooted in recognized industry standards and decades of experience.

Index HealthTech develops passive, contactless monitoring infrastructure that detects functional decline and physiological drift before adverse health events occur—without wearables, cameras, or subject compliance. The company’s patent-pending Sense™ platform uses mmWave radar and far-field acoustics to continuously measure respiration, mobility, sleep, gait, and behavioral patterns across six domains. These signals are translated into the Healthy Habits Index™ (HHI™), a 0–100 behavioral biomarker that quantifies functional status and change over time. At the system level, Index HealthTech models individual trajectories to identify early-stage decline patterns before they become clinical events or mission-limiting conditions—enabling intervention during the narrow window where outcomes can still be altered. The platform is designed for environments where traditional monitoring fails: uncontrolled living spaces, high-throughput care settings, and operational environments where compliance-dependent tools are impractical. It requires no physical contact, no per-user calibration, and no behavioral change from the monitored individual. Backed by over $5M in NIH and NIA funding, Index HealthTech is advancing a new class of continuous behavioral biomarkers with direct application to warfighter health monitoring, veteran care, traumatic brain injury recovery, PTSD-related behavioral drift, and post-deployment readiness assessment.

Radiatric Inc. is dedicated to developing and commercializing innovative technologies to improve outcomes for patients with blood stream infections that can lead to sepsis, and septic shock. Antimicrobial resistance is a serious global health threat. Our flagship medical device, our RAD-01 system, is an extracorporeal non-antibiotic device designed to treat blood stream infections by targeting and killing pathogens even multi drug-resistant organisms. The company's focus is on non-pharmacological methods of killing pathogens, aiming to reduce the mortality and long-term effects associated with sepsis.

HBOX Therapies GmbH is a medical device company based in Aachen, Germany, dedicated to developing next-generation extracorporeal gas exchange solutions for patients with acute respiratory failure. Founded in 2021, the company leverages advances in artificial lung technology, augmented gas management, and innovative blood pumps to deliver compact, efficient, and user-friendly respiratory support systems. Their goal is to provide safer, less-invasive alternatives to conventional mechanical ventilation, thereby improving patient outcomes and reducing ICU resource strain.

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.

Vira Regen is a regenerative biotech company pioneering a new class of gene-specific bioelectronic medicines designed to accelerate the body’s natural healing processes. By harnessing the body’s bioelectric network and genetic signaling pathways, the company is developing noninvasive electroceutical therapies targeting bone fracture healing, musculoskeletal injuries, osteoarthritis, osteoporosis, and cancer. Focused on addressing the root causes of disease and tissue damage, Vira Regen aims to redefine regenerative medicine through precision bioelectric therapeutics that promote faster, more effective recovery and tissue regeneration.

Applied Research Associates, Inc. (ARA) is a globally recognized scientific research and engineering company dedicated to solving critical national problems to improve safety, security, and quality of life. Founded in 1979, ARA is 100% employee-owned and offers innovative technologies and solutions across various sectors, including national security, infrastructure, health solutions, and energy and environment. The company is committed to delivering mission-critical solutions that exceed expectations and lead to new possibilities.

Prospect Life Sciences is a medical device development and manufacturing partner offering integrated, end-to-end solutions from concept through global market fulfillment. The company provides comprehensive capabilities in research and design, product development, manufacturing transfer, scalable production, and regulatory compliance, leveraging ISO 13485:2016-certified and FDA-registered quality management systems. With facilities in the USA and Costa Rica, the company serves as a strategic partner for both early-stage and established organizations, enabling efficient, compliant, and scalable innovation in the medical device sector.

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.

Brinter is a pioneering US-based MedTech firm focused on revolutionizing tissue engineering through the development of 3D bioprinted biocomposite regenerative implants, known as BioMods™, which aim to restore damaged tissue and replace conventional implants, launching in orthopedics/tendons and ligaments. The company driven by a team of visionary entrepreneurs and leading bioscientists and engineers.

Opticyte is a medical device company dedicated to transforming the standard of care for hemorrhage, sepsis, and other leading causes of organ failure. Their mission is to save lives through early detection and real-time measurement of cellular and blood oxygen levels, providing accurate diagnostics for all skin tones and addressing critical health equity issues. Founded in 2016 as a spinout from the University of Washington, Opticyte is pioneering the first device to measure oxygen inside cells in real time, aiming to reduce organ failure and death associated with hemorrhage, sepsis, and other critical illnesses. The company is recognized for its innovative approach, commitment to health equity, and strong leadership in medical technology.

Calla Lily Clinical Care develops patented medical device technologies engineered to improve intravaginal drug delivery for women's health, focusing on clinical needs such as fertility support, pregnancy management, prevention of recurrent miscarriage, and restoration of the vaginal microbiome. Recognized for innovation, the company maintains collaborative partnerships with clinical and academic institutions and secures funding to advance clinical trials and R&D. Their technology is designed for leak prevention, convenience, and dosing confidence, with a strong commitment to sustainability and social impact as a certified B-Corporation.

NeuEsse Inc. is dedicated to advancing skin health through innovative plant-based technologies. Their mission is to provide effective solutions for skin repair, addressing challenges such as severe burns, wounds, and trauma. Their flagship product, OmegaSkin™, is a human skin substitute made from soy protein, designed to enhance healing outcomes with minimal scarring. NeuEsse aims to meet the unmet needs in wound treatment, offering products that are sustainable, vegan-friendly, and require no special handling.

Hemanext is a privately held medical technology company specializing in oxygen-controlled red blood cell processing and storage systems for transfusion medicine. The company develops, manufactures, and commercializes innovative storage solutions that preserve the quality and function of red blood cells by limiting oxygen and carbon dioxide exposure, with the goal of improving transfusion outcomes for patients with chronic and acute conditions. Hemanext's products have received FDA De Novo marketing authorization and CE Mark certification, enabling global distribution. The company is recognized for its focus on scientific evidence, operational compatibility, and strategic partnerships with blood establishments and clinical researchers.

Luna Labs is a world-class technology and product development resource for the defense and healthcare industries. Collaborating across our core capabilities in Advanced Materials, Engineered Systems, and Biotechnology, our teams generate solutions for the most demanding environments and customers to save time, save money, and save lives. We partner with universities, government labs, and other world class companies to explore technological feasibility of new ideas, align technologies with customer needs, and generate solutions. Working with a robust global network of manufacturers, suppliers, licensees, and distributors, Luna Labs develops everything from small-scale prototypes up to market-ready products.

Minnesota Wire is a privately owned, industry-leading custom wire and cable manufacturer based in St. Paul, Minnesota, with over 50 years of experience. The company specializes in designing, developing, and manufacturing high-performance wire, cable, and interconnect assemblies for mission-critical applications across medical, aerospace, defense, and industrial markets. Renowned for its commitment to innovation, quality, and engineering excellence, Minnesota Wire leverages advanced R&D, vertically integrated manufacturing, and a customer-centric approach to deliver life-saving connections and cutting-edge solutions. The company is AS9100, ISO9001, IPC-620, and MIL-STD certified, and is recognized for its contributions to technological advancement, community impact, and sustainability. Minnesota Wire is now a woman-owned business, marking a new era of growth and inclusivity.

Life Protect specializes in the design and manufacture of novel personal protective equipment (PPE), such as face masks and N95 and N99 respirators in the United States with a focus on scientific development, clinical integration, supply chain reliability, and regulatory compliance for healthcare and emergency use.

RTM Vital Signs LLC is a Philadelphia-based medical device company focused on transforming healthcare from reactive and hospital-centered to preventive, proactive, evidence-based, and person-centered. Specializing in real-time sensing, monitoring, and analysis of critical health information, RTM Vital Signs targets cardiovascular and respiratory health. The company leverages proprietary, cost-effective monitoring technology, advanced sensors, and AI-driven diagnostic algorithms to provide continuous, real-time health status tracking for both hospital and ambulatory patients. Their mission is to enable better health outcomes, lower costs, and improve patient and staff experiences through innovative wearable devices and continuous monitoring solutions. RTM's patented solutions are designed for seamless integration with smart devices and wearables, supporting timely diagnosis, predictive analytics, and improved telemedicine capabilities. Their technology also addresses key public health challenges such as hypertension, respiratory compromise, and opioid-induced respiratory depression, with applications extending to fitness, industrial safety, and veterinary medicine.

SutureTech is a surgeon-founded medical device company based in Durham, North Carolina, specializing in the development of innovative internal fixation implants and surgical instruments for soft tissue and tendon repair. The company is dedicated to advancing orthopedic procedures by delivering clinically informed, surgeon-driven solutions that streamline surgical steps, enhance repair strength, and improve patient outcomes. SutureTech's flagship product, RapidFix™, is an all-suture dual anchor system designed for efficient, reliable fixation of soft tissue to bone, and has received FDA 510(k) clearance.

Altrazeal Life Sciences Inc. is a specialty medical technology company dedicated to developing and commercializing innovative drug delivery systems. Their mission is to improve patient outcomes by providing comprehensive solutions for patients, providers, and payers. The company is known for its patented Altrazeal® Transforming Powder Dressing, which optimizes the wound healing environment and supports tissue repair.

Corscience is a German-based medical technology development and manufacturing provider specializing in advanced solutions for defibrillation, patient monitoring, and vital sign acquisition. The company supports OEMs and medtech startups internationally with expertise across R&D, regulatory affairs (including MDR and FDA compliance), quality management, lifecycle management, and technical consulting. Their track record includes the delivery of complex, safety-critical systems and robust integration of electronic, software, and mechanical components in medical devices.

Genomind is a leader in precision medicine for mental health, dedicated to helping healthcare providers and patients make better prescribing decisions by leveraging genetic, lifestyle, and environmental data. Their mission is to personalize mental health treatment and improve outcomes for individuals, providers, and healthcare systems. Genomind supports a wide range of stakeholders, including individuals, providers, long-term care facilities, ACOs, employers, health plans, and international partners. Through innovative pharmacogenetic testing, precision medicine software, consultative services, and educational resources, Genomind aims to advance mental health care and empower both patients and professionals.

Rx Bandz is dedicated to developing innovative, next-generation auto-injectors and life-saving formulations that provide simple solutions for patients, first responders, and the military. Their mission is to enhance the delivery of injectable medications, ensuring accessibility and ease of use for anyone, anytime, anywhere.

LifeBoard Medical is a healthcare-focused company, led by experienced trauma surgeons and experts in software and solution development, aimed at creating technological improvements in trauma care, with an emphasis on advancing situational awareness for improved team dynamics, improving patient outcomes and improved QI reviews. The company demonstrates a strong commitment to research objectivity and regulatory compliance, particularly in managing financial conflicts of interest in publicly funded research.

Exactics specializes in the development of rapid, affordable, and accurate at-home diagnostic tests for infectious diseases. The company employs a consumer-oriented design and scalable technology platforms to provide point-of-need diagnostics that aim to increase early disease detection and convenience, with a focus on lowering costs and minimizing development timelines.

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.

Inertia is an innovation-driven firm delivering end-to-end design, engineering, prototyping, and manufacturing for medical, clean tech, industrial, safety, and advanced hardware industries. Distinguished by their tightly integrated evidence-based approach—including strategy, human factors, regulatory and advanced manufacturing—they execute at every phase: from early startup product validation through SMB innovation acceleration, to full-scale manufacturing for startup and large enterprises. Their unique differentiator lies in the seamless integration of product strategy, development, and manufacturing under one roof—enabling clients to optimize quality, achieve rapid speed-to-market, and realize measurable cost and risk reductions. With robust quality systems, client-centered project management, and a reputation for transparency, Inertia consistently sets new standards for product innovation and commercialization.

Tensentric is a contract design and manufacturing firm focused solely on medical device, in vitro diagnostic, and advanced therapy markets. We're ISO13485 certified and FDA registered to help our clients bring their new technology and products to market.

Metro Preclinical Consulting, LLC, founded in 2024 and based in New Jersey, USA, provides comprehensive support to medtech companies in the strategy and execution of preclinical evidence generation. The company offers a tailored approach to maximize data while minimizing animal use in preclinical development programs, supporting product research and regulatory filings. Metro Preclinical is committed to being a responsive, diligent, and candid partner, guiding products from concept to clinic.

Axiom Management Solutions is a veteran-owned business offering consulting and service support across all stages of medical device development. Axiom's core philosophy: Early-stage medtech innovators deserve to own their development journey without the burden of heavy overhead or restrictive partnerships. Axiom empowers developers to bring their vision to life with precision, flexibility and expert support. The company specializes in helping innovators navigate regulatory requirements, develop prototypes, establish quality management systems, and take medical devices from concept to commercialization.

PDV MedTech, previously known as Phoenix DeVentures, is a U.S.-based company founded in 2001 specializing in medical device design, development, and ISO 13485:2016-certified contract manufacturing. Acquired by INDO-MIM in 2025, the company offers end-to-end solutions from prototyping to high-volume production with capabilities in injection molding, 3D printing, fabrication of mold tools, and cleanroom assembly. PDV MedTech supports startups and innovators in commercializing their devices through regulatory support, quality management, and scalable manufacturing across locations in California, Colorado, and Utah.