Area · current view

FDA

Digital health, SaMD, AI/ML device guidance · 4 briefs

The AI "state of play" synthesis for each area is a SignalHealth Pro feature. Below is the area's brief history.

Current & historical briefs

Jun 22, 2026

FDA Classifies Bacillus spp. Secreted-Protein IVD as Class II with Special Controls

Notable

Jun 17, 2026

Study Maps Two Decades of FDA Digital Medical Device Authorizations

Notable

Jun 16, 2026

FDA Draft Guidance Reframes Safety Rules for AI-Enabled Medical Devices That Evolve Post-Market

High

Jun 16, 2026

Decision-Theoretic Framework Proposes When LLMs Should Stay Silent in Clinical Settings

Notable