fda-cleared
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Konrad Morzkowski
Konrad Morzkowski is the Swedish-born co-founder and CEO of WearLinq, a San Francisco medtech company commercializing eWave, an FDA-cleared 6-lead wireless ECG monitor that ships heart data from a patch on the chest to a smartphone in your pocket. A Chalmers and Stanford engineer named to Forbes' 30 Under 30 in Healthcare (2024), he traded a plan to build AI for healthcare for the harder problem of getting clinical-grade cardiology out of the hospital and onto the patient.
Charvi Shetty
Charvi Shetty is the co-founder and CEO of Aluna, a San Francisco respiratory-health company that makes an FDA-cleared, pocket-sized spirometer paired with games and AI so patients can track lung function from home and send the data to their doctors. A UC Berkeley bioengineer with a UCSF master's in biomedical imaging, she left an algorithm-engineering job at Genentech to build the device, became the youngest recipient of an NSF SBIR grant, and is recognized as one of the youngest female CEOs to bring an FDA-cleared healthtech device to market. In 2023 Aluna raised a $15.3M Series B, bringing total funding to about $27M.
Marissa Fayer
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.
Scott Roth
Scott Roth is a cardiologist who spent two decades reading echocardiograms before deciding the ICU needed a faster way to see the heart. As founder and CEO of ImaCor, he built hemodynamic ultrasound (hTEE) around the disposable, pencil-thin ClariTEE probe that stays in a patient for up to 72 hours, giving clinicians a live look at cardiac filling and function instead of waiting on lab results. In 2022 ImaCor and Clarius released the Zura Handheld, billed as the world's first handheld TEE system, putting that view in a 22-ounce device.
Mike Rosenbluth
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
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
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
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
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
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
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
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?