The FDA's comment window on regulating generative AI medical devices closed October 19, with a proposed two-axis risk framework and physician-style competency testing emerging as the leading ideas for overseeing autonomous clinical AI.
Oura's new partnership with clinical platform Fullscript puts smart ring health data directly in front of practitioners, a step toward normalizing wearable data in real care decisions.
The University of Texas System struck an enterprise-wide deal to expand Abridge's ambient AI scribe across all eight of its health institutions after a pilot saw clinician usage grow 73% in a year.
Boehringer Ingelheim expanded its partnership with AI drug discovery company Owkin to target oncology and immunology, using federated learning across hospital data networks to find new drug targets.
ARPA-H is putting $62.7 million behind ADVOCATE, a push to build the first FDA-authorized autonomous AI agent for heart failure care, with Tempus AI, Updoc and Atman Health racing toward a two-year authorization deadline.
Whoop's $575 million Series G, backed by Abbott and Mayo Clinic, pushes its valuation to $10.1 billion as wearable makers race to reposition continuous health tracking as a clinical, not just fitness, tool.
The FDA's comment period on a preliminary framework for regulating generative-AI medical devices closes October 19, even as a citizen petition challenges whether such AI tools fall under the agency's jurisdiction at all.
EliseAI raised $350 million at a $4 billion valuation, nearly doubling its year-earlier mark, as the AI agent company pushes further into healthcare operations alongside its established housing automation business.
Utah's Medical Licensing Board has demanded suspension of a state-sanctioned pilot letting Doctronic's AI renew prescriptions, citing safety concerns and reigniting debate over whether such tools fall under FDA medical device jurisdiction.
Function Health and Google will let US users connect lab results with Pixel Watch and Fitbit data this fall, deepening Google's health ecosystem as Apple pushes its own biomarker-testing features through Quest Diagnostics.