fda-de-novo
(6)
Interscope, Inc.
Interscope, Inc. is a Northbridge, Massachusetts medical device company that develops the EndoRotor, a flexible, powered endoscopic resection system that dissects, resects, and collects tissue in the gastrointestinal tract without thermal energy. Founded in 2011, the company created the first flexible microdebrider designed for the digestive tract and holds the first and only FDA marketing authorization for Direct Endoscopic Necrosectomy (DEN) in walled-off pancreatic necrosis. Interscope sells to interventional gastroenterologists and hospitals, and distributes the EndoRotor system through a partnership with Micro-Tech Endoscopy.
Jeffery Ryan
Jeffery Ryan is the co-founder, president, and CEO of Interscope, Inc., a Massachusetts medical device company behind the EndoRotor System, a mechanical, non-thermal tool for interventional gastroenterology and pulmonology. A former U.S. Air Force captain who moved into medical device sales at Medtronic and Smith & Nephew, Ryan launched Interscope in 2013 with physician co-founder Dr. Ramon A. Franco, Jr., steering the EndoRotor from concept to FDA clearances and a 2020 distribution partnership with Micro-Tech Endoscopy.
Kintsugi
Kintsugi is a Berkeley-based AI company that built voice biomarker technology able to flag signs of clinical depression and anxiety from roughly 20 seconds of free-form speech. Founded in 2019 by Grace Chang and Rima Seiilova-Olson, it sold an API-first platform into call centers, telehealth, and remote patient monitoring before winding down operations in early 2026 and releasing its models, methods, and research into the public domain.
Clairity, Inc.
Clairity is a Boston-based healthtech company that built Clairity Breast, the first FDA-authorized AI platform that predicts a woman's five-year risk of breast cancer directly from a routine screening mammogram. Founded by Harvard radiologist Dr. Connie Lehman, the company turns images already sitting in the medical record into a forward-looking risk score, aiming to move breast care from late-stage detection toward early, equitable prevention.
Luminopia
Luminopia is a commercial-stage digital therapeutics company that turns a child's favorite TV shows into FDA-cleared medicine for amblyopia (lazy eye). Children wear a VR headset for one hour a day, six days a week, and watch curated, real-time-modified episodes that retrain the brain to use both eyes together. Founded by Harvard dropouts and incubated at Boston Children's Hospital, Luminopia One became the first FDA-approved digital therapeutic for a neuro-visual disorder.
Scott Xiao
Scott Xiao is the co-founder and CEO of Luminopia, a Boston-area digital therapeutics company whose lead product turns watching cartoons in a VR headset into an FDA-approved treatment for amblyopia, the leading cause of vision loss in children. He left Harvard with classmate Dean Travers to build the first VR-based therapeutic ever cleared by the FDA, partnering with Sesame Workshop, Nickelodeon, and DreamWorks for content and with Boston Children's Hospital and MIT for the science.