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.
Swedish digital health provider Yazen's $56 million round, led by Verdane, shows continued European investor appetite for technology-enabled care models amid aging populations.
OpenAI says 230 million people ask ChatGPT health questions weekly, as its dedicated Health feature expands to pull records from One Medical, Kaiser Permanente and Apple Health — raising questions about AI's growing role in informal medical advice.
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.
Quebec startup Bia Health raised C$2.15 million to expand an AI assistant that helps clinicians avoid unnecessary imaging and referrals, targeting the roughly 30% of Canadian healthcare spending estimated to go toward low-value care.
OpenEvidence and Johns Hopkins Medicine will jointly redesign medical training and clinical decision-support tools for the AI era, extending OpenEvidence's reach into major academic health systems weeks after a similar deal with Penn Medicine.
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.
Heidi Health has launched Heidi II, adding AI agents that handle administrative tasks around patient visits while the company insists clinicians retain final approval over decisions.
Healthleap raised $38 million to expand its AI-driven patient screening platform to identify additional medical conditions, part of a broader wave of funding for AI tools aimed at catching diagnoses earlier.