Find here all our blog posts tagged with: Generative AI.

A glass-like translucent heart floating above a faint grid of pulse waveforms, symbolizing AI-assisted diagnostics under regulatory review.

FDA's GenAI Guidance Gap Puts Lifecycle Design on the Critical Path

FDA is still soliciting input on generative AI device oversight while conventional AI/ML tools keep clearing through 510(k), forcing sponsors to design lifecycle monitoring ahead of guidance.

Abstract photograph of light flowing between a human hand and a robotic diagnostic arm, symbolizing continuous oversight of AI in medicine.

FDA's Discussion Paper Moves the Goalposts on GenAI Devices

FDA's generative AI discussion paper signals a shift from one-time approval to continuous, competency-based testing that life sciences compliance teams should prepare for now.