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Everything on the platform tagged with fda-cleared.
G-Tech Medical builds the GutTracker, a thin wireless wearable patch its team calls an 'EKG for the Gut.' Worn on the abdomen for up to six days at home, the patch reads the faint electrical signals that drive the stomach, small intestine, and colon, then streams them over Bluetooth to the cloud, where algorithms turn the noise into patient-specific motility data. The Mountain View company aims to replace short, single-organ, in-clinic tests with continuous, whole-gut measurement so physicians can finally see how a digestive system actually behaves day to day.
CoapTech is a Baltimore-based medical technology company that built the world's first ultrasound-guided gastrostomy system. Its FDA-cleared PUMA-G System lets bedside clinicians place feeding tubes using only ultrasound imaging and a patented magnet-aligned catheter, replacing procedures that traditionally required an operating room, endoscopy, or interventional radiology. The approach aims to make feeding-tube placement faster, safer, and cheaper, and has been used in more than 1,000 patients across ICUs, step-down units, and long-term acute care hospitals.
NuvoAir Medical is a virtual-first cardiopulmonary care company that helps patients with chronic heart and lung conditions - COPD, asthma, and CHF - manage their health from home before they end up in a hospital. Founded in Stockholm in 2015-2016 by Lorenzo Consoli and now headquartered in Boston, NuvoAir pairs FDA-cleared connected devices like the Air Next home spirometer with a clinical care team and data-driven monitoring. Its model is built around value-based care, with studies showing meaningful reductions in medical spend and hospitalizations. The company also powers decentralized clinical trials for pharma partners.
Sibel Health is a Chicago-based digital health company spun out of Northwestern University that builds clinical-grade, fully wireless wearable sensors paired with AI analytics and a cloud platform. Its flagship ANNE One system continuously tracks vital signs - heart rate, respiratory rate, temperature, SpO2, pulse and more - for patients from neonates to adults, in hospitals, at home, and in low-resource settings around the world. The mission is to deliver 'Better Health Data for All.'
Springbok Analytics is a Charlottesville, Virginia AI company spun out of the University of Virginia that turns standard 2D MRI scans into precise, interactive 3D maps of the musculoskeletal system. Its FDA-cleared platform quantifies up to ~140 individual muscles - measuring volume, fat infiltration, asymmetry, scar tissue, edema and tendon morphology - to create a 'digital muscle twin' used by elite sports teams, clinical researchers, and longevity programs to assess injury risk, track rehab, and monitor age-related muscle change.
MediView XR is a Cleveland, Ohio med-tech company building augmented-reality 'X-ray vision' for surgeons. Founded in 2017 on Cleveland Clinic intellectual property, MediView's FDA-cleared XR90 platform and OmnifyXR Interventional Suite let clinicians see a patient's 3D anatomy - bone, tissue, organs, and vasculature - holographically projected through the skin during minimally invasive, ultrasound-guided procedures. Backed by GE HealthCare, Mayo Clinic, and Cleveland Clinic, the company raised a $24M Series A in October 2025.
Marissa Fayer is a 25-year medtech executive who runs DeepLook Medical, an AI diagnostics company that helps radiologists spot breast cancer earlier in women with dense breast tissue, which she took from concept through FDA clearance into global commercialization. She is also the founder of HERhealthEQ, a nonprofit that has reached over 128,000 women across 12 countries by deploying medical devices for cancers, maternal health, and cardiovascular disease. A partner at women's-health fund Goddess Gaia Ventures and author of the forthcoming book 'Undervalued to Unavoidable,' she argues women's health is not a charitable cause but economic infrastructure that has been systematically underestimated.
OrthoFX is a Fremont, California clear-aligner company building the next generation of orthodontic care - shorter-wear NiTime aligners made of a proprietary HyperElastic polymer, paired with FXOnTrack, an AI platform that lets doctors monitor patients remotely. Founded by Invisalign veterans, it is a hybrid B2B/D2C model designed to make straight teeth predictable, affordable, and a lot less tedious.
RapidAI builds FDA-cleared clinical AI software that reads CT, CTA, CT perfusion and MRI scans to flag stroke, aneurysms and pulmonary embolisms in minutes - giving hospital teams a faster path to treatment. The platform began life as the Stanford spin-out iSchemaView and now runs in more than 2,000 hospitals across 100+ countries.
ZAP Surgical Systems is a San Carlos, California medical device company that designed and manufactures the ZAP-X Gyroscopic Radiosurgery platform - a self-shielded, vault-free system for non-invasive treatment of brain tumors and other intracranial conditions. Founded by Stanford neurosurgeon and CyberKnife inventor John R. Adler, ZAP is on a mission to democratize stereotactic radiosurgery by eliminating the need for radioactive isotopes and concrete bunkers.
Promaxo builds the world's first single-sided, in-office MRI platform - a compact magnet, AI, and robotics stack that lets urologists run image-guided prostate biopsies and focal treatments in their own clinic, without a hospital scanner suite.
Signos is a San Francisco Bay Area digital health company pairing a continuous glucose monitor with an AI-driven app to help non-diabetic adults lose weight and improve metabolic health through real-time, personalized feedback on food, sleep, stress and exercise.
VELMENI is a Sunnyvale-based dental AI platform that uses computer vision and deep learning to analyze 2D and 3D dental radiographs in real time. Its FDA-cleared flagship product, VELMENI for DENTISTS, is the first dental AI approved to detect pathologies in panoramic X-rays — catching caries, bone loss, and other findings that experienced clinicians miss roughly one-third of the time. Beyond diagnostics, the platform automates insurance claims, enables voice-assisted periodontal charting, interprets CBCT scans, and delivers VR-based patient education, all from a single integrated workflow. Founded in 2020 by CEO Mini Suri and Chief Dental Officer Dr. Arvin Oberai, the company has been beta-tested by over 1,300 dentists across 500+ practices in 50+ countries.
Viz.ai is an AI-powered care coordination platform trusted by over 2,000 hospitals across the United States. The company's suite of 50+ FDA-cleared algorithms analyzes medical imaging data in real time - detecting strokes, brain hemorrhages, aneurysms, pulmonary embolisms, and cardiac conditions - then instantly alerts the right clinical team so treatment can begin minutes faster. Founded in 2016 by neurosurgeon Dr. Chris Mansi and machine learning researcher Dr. David Golan, Viz.ai has grown into a platform covering 230 million lives, supporting 70,000+ healthcare providers, and partnering with 14+ leading pharmaceutical companies to accelerate drug development and patient access.
Mike Rosenbluth is the Founder and CEO of Swing Therapeutics, the San Francisco-based company behind Stanza - the first FDA-authorized prescription digital therapeutic for fibromyalgia symptoms. A Stanford-trained mechanical engineer with a UC Berkeley PhD in Bioengineering, Rosenbluth spent years at McKinsey, a VC firm (Versant Ventures), and cancer diagnostics company Veracyte before founding Swing in 2019. His company's landmark PROSPER-FM Phase 3 trial results were published in The Lancet in 2024, and Swing has raised over $30 million to bring evidence-based, non-drug behavioral therapy to the estimated 4 million Americans with fibromyalgia.
Neda Razavi is the CEO and Chairwoman of the Board at iSono Health, a South San Francisco medtech company building the world's first wearable, automated, portable FDA-cleared 3D breast ultrasound system. With 25 years of experience launching 65 products across six global platforms and generating over $9 billion in cumulative revenue at companies including Abbott, Roche, Medtronic, and Natera, Razavi joined iSono Health as an early investor and advisor before taking the helm in November 2023 to lead commercialization of the ATUSA system — a 2-minute, hands-free breast imaging device that pairs robotics, AI, and cloud analytics to make early breast cancer detection accessible to OB/GYNs and primary care providers without requiring a trained sonographer.
Nishith Khandwala (Nish) is the co-founder and CEO of Bunkerhill Health, a San Francisco-based AI company building the operating system for clinical action inside health systems. A Stanford computer scientist who started in AI labs with no healthcare background, he pivoted after physicians walked in with real clinical problems - and after his own father's heart attack forced him to ask why his coronary calcium AI wasn't reaching patients. Bunkerhill's Carebricks platform now powers 7+ clinical domains at major health systems including UTMB, HCA Florida, MedStar, and WVU Medicine. The company has raised $30.4M from Sequoia, Optum Ventures, and Y Combinator, earned multiple FDA clearances, and landed Nishith on Forbes 30 Under 30 and the inaugural Mayfield Divot AI List.
Souvik Paul is the CEO and Founder of Aurie, a medtech company that built the first FDA De Novo-cleared reusable intermittent catheter system. A Harvard-educated designer and former J&J strategist, Paul was driven to start Aurie after witnessing a family member's struggle with catheter-associated infections following a spinal cord injury. His Oakland-based startup has raised $14.24M and is pioneering a no-touch, automatically disinfecting catheter system designed to transform care for the 600,000 Americans who rely on intermittent catheters.

Chris Mansi is a Cambridge and UCL-trained neurosurgeon turned AI entrepreneur, and the Co-founder and CEO of Viz.ai - the company that puts an AI brain between a CT scanner and a surgeon so that patients who are about to die of a stroke stop dying from delays. Named to TIME100 AI in 2024, Mansi built Viz.ai from a Stanford dorm-room insight into a platform covering nearly 2,000 U.S. hospitals and 230 million lives, reducing stroke diagnostic timelines by more than an hour - one patient at a time, every ten seconds.
Enhao Gong is the CEO and co-founder of Subtle Medical, a Stanford-born AI healthcare company that has earned 9 FDA clearances for deep learning-powered medical imaging products. A PhD graduate from Stanford in Electrical Engineering, Gong co-founded Subtle Medical in 2017 alongside Stanford neuroradiologist Dr. Greg Zaharchuk, and has grown the company to serve 1,000+ scanner installations globally, touching 2.5 million patients annually. Before Subtle Medical, he co-founded Polarr, an AI photo-editing startup used by tens of millions. He has been recognized by Forbes 30 Under 30 (China/APAC, 2018), Fortune 40 Under 40, and Radiology Business 40 Under 40 (2024), and led Subtle Medical to TIME's World's Top HealthTech Companies list in 2025.

Mini Suri is the Co-Founder and CEO of VELMENI, a Silicon Valley-based FDA-cleared dental AI company that analyzes 2D and 3D dental X-rays to detect pathologies that even experienced dentists miss. Drawing on 20+ years at Citi, a stint building intelligent automation at Uber, and an MBA from MIT Sloan, she pivoted to healthtech after a personal brush with the cost of missed diagnoses. Under her leadership, VELMENI has grown to serve 500+ dental offices across 50+ countries with AI-powered tools for panoramic, bitewing, periapical, and CBCT imaging - aiming to bring affordable, high-quality dental diagnostics to one billion patients worldwide.
Sharam Fouladgar-Mercer is the Co-Founder and CEO of Signos, the company behind the first FDA-cleared over-the-counter glucose monitoring system for weight management. A Princeton computer science graduate and Harvard MBA, he played NCAA Division I ice hockey before building a career spanning VC at Sierra and Shasta Ventures, co-founding PR tech company AirPR (later Onclusive), and ultimately creating Signos in 2018 after his own lifelong struggle with weight and the death of his diabetic grandmother inspired him to ask: why wait until someone is sick to give them metabolic data?