medical device development

Epitel is a digital health company headquartered in Salt Lake City that modernizes brain health solutions to improve seizure monitoring and detection. It has developed a wearable, wireless EEG monitoring platform using a proprietary cloud-based wearable sensor system and AI technologies. Epitel received FDA clearance for its first product, the REMI Remote EEG Monitoring System, in 2021.

AI-based event detectioncloud data storage and reviewwearable wireless EEG monitoring

Fisher & Paykel Healthcare is a designer, manufacturer and marketer of products and systems for use in acute and chronic respiratory care, surgery and the treatment of obstructive sleep apnea. Founded on the development of its first prototype respiratory humidifier in 1969, the company has pioneered respiratory humidification for more than 50 years and produces humidification and respiratory support devices, masks, breathing circuits and related accessories for hospital and homecare use.

designmanufacturingrespiratory humidification

FLOESSA LLC is developing a closed-loop wearable system designed to simplify infant feeding, currently in its engineering validation and R&D phase. The company describes its technology as a low-profile, whisper-quiet wearable that fits inside a standard bra, with a proprietary internal flow path and zero-airflow architecture intended to protect infant nutrition from expression to feeding. The device is not yet FDA-cleared for commercial sale.

Computational Fluid Dynamics (CFD)fluid-structure interaction (FSI) modelingmicrofluidic engineeringregulatory strategy

Flosonics Medical is a medical device company engaged in the research and development of innovative ultrasound technology, founded in 2015. Its mission is to improve patient care and the practice of medicine through technology-enabled solutions and clinical research. The company developed FloPatch, the first wireless, wearable Doppler ultrasound device that provides real-time hemodynamic assessments to help clinicians make informed decisions on fluid resuscitation.

AI algorithm developmentultrasound technology research and development

Freyya is developing the Freyya™ pelvic floor monitoring and feedback device, described as the first on-the-go pelvic floor monitoring and feedback device for people with pelvic floor dysfunction. The device leverages a tampon-like biosensor to monitor pelvic floor physical therapy and can be used while stationary and during moderate to vigorous exercise. The product is currently in development and not available for sale, and is not cleared or approved by the FDA or CE Marked.

biosensor developmentdata sharing and monitoring softwarepelvic floor biomechanics research

Glau-Vue Ophthalmic Inc is a registered C-Corporation in Connecticut operating as a medical device company. It has developed a patented medical device, the Glau-Sert, for the treatment of open angle glaucoma, the result of more than 10 years of research, design, redesign and re-engineering. The company has applied for a US patent for an ophthalmic medical device under a 510K.

ophthalmic implant design

HFR is a small R&D company in Southern California, started in 2015, that develops and manufactures advanced products from early R&D through production. Its expertise spans medical imaging devices, vision testing products, large area flexible electronic circuits, photonic and magnetic sensors, and software development including edge-fog-cloud distributed computing for healthcare IT.

computational fluid dynamicscontract manufacturingedge-fog-cloud computingElectrical Designenvironmental sensinglarge area flexible circuit manufacturingmachine learningmass spectroscopymechanical designoptical designphotonics and imagingR&Dsoftware developmentvacuum technology

Helande Innovations, Inc. is a San Diego-based medical device company developing Nervida, an investigational implant for chronic pain designed to renew relief when pain returns without another invasive procedure. Nervida is in preclinical development and is not approved or cleared for commercial sale; its safety and effectiveness have not been established. The company brings together clinical insight and engineering, with founders experienced in medical device development, executive leadership, and interventional pain medicine.

implantable therapies

Hubly Surgical develops the Hubly Drill, an FDA-cleared, first and only single-use cranial access kit and drill for bedside neurosurgery, specifically drilling burr holes into the skull. Its features include SMART Auto-Stop, unique drill bit geometry designed to reduce over-plunge, an LED Force Indicator, and a single-use cordless power design enabling one-handed procedures. The company was founded by serial medtech founders and engineers and developed the device with neurosurgeons.

burr hole drillingFDA-cleared device manufacturing

iHnnova LLC is a biomedical startup spun out from the University of Puerto Rico at Mayagüez developing a handheld, portable induction heating device for localized thermal therapy using magnetic fluid hyperthermia. It is working on delivering MFH treatment to cancer patients with metallic implants using its patented handheld laparoscopic induction heater (LIH) and transrectal induction heater (TRIH) for pancreatic and prostate cancer.

induction heatingmagnetic fluid hyperthermia

InfraScan, Inc. is a medical device company that invented and distributes hand-held diagnostic devices for head injury and stroke assessment based on Near-Infrared (NIR) technology. Its Infrascanner portable brain scanner enables clinicians to detect intracranial bleeding in patients with head trauma; it is FDA-cleared and CE Marked.

commercialization and distributionnear-infrared (NIR) spectroscopy

InTailor Bariatrics develops automated endoscopic solutions that simplify and standardize weight-loss procedures for broader medical access. The company describes itself as a preclinical NIH-funded device startup seeking seed financing, aiming to provide patients and physicians with an easy-to-operate non-surgical/non-pharmacological weight-loss technology.

automated tissue fixationendoscopic gastroplasty

Interlinked AB is a Swedish medical device company founded in 2016 that develops the patented safety connector ReLink, an advanced breakaway connector for IV lines designed to prevent patient injuries, spill of hazardous drugs, and reduce complications and costs associated with IV catheter complications. ReLink operates under the name LinkUS in the USA.

need-based product development through to commercialisationQMS and regulatory compliance

JelikaLite is a clinical stage medical technology company developing a transformational neuromodulation platform for unmet needs in developmental pediatric disorders. Its lead product, Cognilum, is a home-based LED-based device for children with autism, designed to improve responsiveness, speech, and social interaction. The company received FDA Breakthrough Device Designation and FDA Non-Significant Risk Device Study Designation.

clinical trialsNeuromodulationtranscranial photobiomodulation

JFD-PK Medical LLC is a critical care research and development company founded by Dr. Jameel Durrani, a board-certified pulmonologist and critical care physician with over 20 years of clinical experience. It develops innovative critical care products and serves hospitals, surgery centers, ERs, urgent care clinics, medical facilities, and individual practitioners across the United States, Europe, and Asia.

critical care research and development

Klim-Loc develops human-centered medical technologies that make injectable pharmaceutical preparation and delivery safer, simpler, and more efficient for clinicians, healthcare systems, pharmaceutical companies, and patients. Its patented needle-free vial stopper replaces a single component on the standard pharmaceutical vial, eliminating the need for a needle during medication preparation without new equipment, retraining, or supply chain disruption.

human factors engineeringSystems Engineering