Find here all our blog posts tagged with: AI medical devices.

A line of light divides a clinical space, symbolizing the boundary between regulated and unregulated AI tools.

The Boundary FDA Won't Police

FDA's 2026 clinical decision support guidance draws a line around what counts as a regulated device, leaving compliance teams to make that call themselves.

Abstract streams of glowing data particles converging into a single current against a dark clinical backdrop.

Routine Health Data Is Fueling AI Devices Faster Than FDA Can Define the Standard

FDA's December 2025 real-world evidence guidance lets sponsors train AI devices on routine health data, but provenance and bias standards remain undefined.

A wearable health device shown split between a clinical, regulated half and a consumer wellness half, illustrating the FDA's shifting classification line.

FDA Just Moved the Wellness Line. That Is a Liability Decision, Not a Compliance Break

FDA's broadened wellness classification for AI-enabled wearables forces life sciences leaders to choose their liability posture, not just their regulatory burden.