fda-cleared-ai
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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.