fda-cleared-ai
(6)
Harrison.ai
Harrison.ai is a Sydney-based clinical AI company founded in 2018 by brothers Dr Aengus Tran and Dimitry Tran. It builds artificial-intelligence software that helps clinicians read medical images faster and more accurately - flagging urgent findings on chest X-rays and brain and chest CT scans, and streamlining pathology review. Its diagnostic products, radiology brand annalise.ai and pathology joint venture franklin.ai, are used at more than 1,000 healthcare sites across four continents, with regulatory clearance in 40-plus countries. The company positions itself as a builder of foundation models for medicine, releasing harrison.rad.1, a radiology-specific multimodal large language model. Harrison.ai raised a US$112 million Series C in February 2025 to fund a US expansion, taking total capital raised past US$240 million.
Cleerly
Cleerly is a Denver-based digital healthcare company using FDA-cleared artificial intelligence to analyze coronary CT scans and non-invasively measure plaque, stenosis and the likelihood of ischemia in the heart's arteries. Founded in 2017 by cardiologist James K. Min, the company builds machine-learning software that turns a routine CCTA scan into a quantitative, vessel-by-vessel picture of coronary artery disease - aiming to catch atherosclerosis earlier and help physicians prevent heart attacks rather than react to them.
Digital Diagnostics
Digital Diagnostics is a Coralville, Iowa healthcare AI company that builds autonomous - not assistive - diagnostic systems that make a clinical decision without a physician reviewing the result. Its flagship product, LumineticsCore (formerly IDx-DR), was the first medical device of any kind to receive FDA authorization to make an autonomous diagnosis: it screens for diabetic retinopathy from retinal images at the point of care in primary care offices, no eye specialist required. Founded in 2010 by retina specialist and computer engineer Dr. Michael Abramoff, the company has raised more than $130 million to expand autonomous AI into new disease areas.
Bunkerhill Health
Bunkerhill Health is a San Francisco AI company building the 'system of action' for hospitals. Its Carebricks platform lets health systems create, share, and deploy AI agents that turn routine data - especially CT scans already sitting in the archive - into actionable clinical findings. Born out of Stanford's Center for AI in Medicine and Imaging, the company has racked up a string of first-in-class FDA clearances for opportunistic detection of cardiovascular and bone disease, and in 2026 secured a national CMS reimbursement pathway for AI cardiovascular analysis.
Scott Magargee
Scott Magargee is the CEO and co-founder of Springbok Analytics, a Charlottesville, Virginia company that turns ordinary MRI scans into FDA-cleared, AI-built 3D maps of every muscle in the human body. A former Princeton history major and Top 100 law firm litigator, he traded courtrooms for muscle health, joining the University of Virginia spinout in December 2019 and steering it through a $5M oversubscribed Series A in January 2025 backed by the NBA. Under his watch, Springbok has scanned elite athletes, pro basketball leagues, and clinical-trial patients, chasing a single idea: make muscle visible, measurable, and actionable.
Andrew Lacy
Andrew Lacy is the Founder and CEO of Prenuvo, the company making proactive whole-body MRI scanning a mainstream healthcare tool. A Melbourne-born, Stanford-trained entrepreneur, he previously co-founded Tapulous - the mobile gaming company behind Tap Tap Revenge, acquired by Disney in 2010 - before pivoting to healthcare. At Prenuvo, he has raised $177M in total funding (including a $120M Series B in 2024), grown the company to 110,000+ members across 17 North American clinics, and secured FDA clearance for AI-powered body composition analysis, with plans to expand into Europe and Australia.