The FDA rethinks generative AI devices. The FDA’s August 18, 2026 discussion paper on generative AI enabled medical devices proposes a two axis risk assessment framework, a competency based approach to premarket evaluation modeled on clinician credentialing, and explores accepting greater premarket uncertainty in exchange for greater reliance on postmarket monitoring. Comments are due October 19, 2026 under docket FDA-2026-N-7874.
A UK blueprint for safe AI adoption. The National Commission into the Regulation of AI in Healthcare, chaired by Professor Alastair Denniston, recommends staged authorizations likened to a learner driver license, continuous real world monitoring, public access to safety and adverse incident data, and stronger powers for the MHRA.
Novo Nordisk goes all in on AI. Novo Nordisk announced a collaboration with Anthropic to use Claude models and Claude Science across drug discovery and development, and a multi target partnership with Orbis Medicines worth up to $1.4 billion plus tiered royalties to discover oral macrocycle drugs for cardiometabolic diseases.
Cigna brings frontier AI to cancer care. The Cigna Group and OpenAI are starting with tools for oncology nurses and case managers at Cigna Healthcare and Accredo Specialty Pharmacy that bring together clinical, pharmacy, behavioral and benefits information.
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