The American Hospital Association urged the FDA to adopt flexible, risk-based oversight of generative AI medical tools as the agency's comment period on its discussion paper closed October 19, with patient-safety advocates pushing for firmer rules instead.
The FDA's comment period on regulating generative AI medical devices closed October 19, with the American Hospital Association pushing for a risk-based framework as the agency works toward formal 2027 guidance covering AI in mental health and surgery.
Optellum's lung cancer risk AI, the first both FDA-cleared and Medicare-reimbursed tool of its kind, is now integrated into RapidAI's platform, a combination that could meaningfully speed adoption compared to AI tools lacking payer coverage.
FDA-cleared AI tool TumorSight Risk uses a patient's existing breast MRI to predict cancer recurrence risk without added scans, joining a growing wave of cleared cancer-imaging AI tools even as researchers push for outcomes data beyond accuracy.
Billions have poured into AI drug discovery deals, but no AI-discovered drug has yet won full FDA approval — a gap that will test whether the technology's promise translates into real medicines.
Wearable startup CUDIS launched a smart ring with an AI coach that rewards users with redeemable points for healthy habits, part of a wider push to gamify wellness tracking and boost engagement.
GSK licensed a cellular-biology foundation model from UK biotech Relation Therapeutics in a deal worth up to $110 million, part of a wider pharma shift toward licensing specialized AI platforms.
Zealand Pharma struck a deal worth up to $1.2 billion with AI protein-design company Generate Biomedicines to pursue new obesity treatments, joining a wave of major AI drug discovery partnerships.
Big pharma has committed billions to AI drug discovery deals, but no AI-designed drug has yet reached the market, leaving a growing gap between investment enthusiasm and proven clinical payoff.
India's MeitY Secretary said AI can expand healthcare accessibility and improve diagnosis nationwide, comments reflecting the government's growing emphasis on AI as a tool to address the country's rural doctor shortage.