Stay Up to Date with Medical AI Regulations

Prof. Valmed has become the first LLM powered clinical decision support (CDS) system to win a Class IIb CE mark under the EU Medical Device Regulation (MDR)—a watershed moment that proves generative AI can satisfy Europe’s most demanding safety, quality management, and post market surveillance rules

Microsoft’s new Medical AI Diagnostic Orchestrator (MAI DxO) claims 85 % accuracy on 304 of the New England Journal of Medicine’s hardest cases—four times better than experienced clinicians and at lower simulated cost. The supporting pre print lays out a rigorous, sequential diagnosis benchmark (SDBench) that mimics real clinical decision making. The bar for “state of the art” in Healthcare AI just moved; so did regulators’ and investors’ expectations