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

Abstract image of a heartbeat waveform merging with pharmacy shelves to represent AI moving from device clearance into clinical practice.

Device Clearance Outpaces Practice Governance

Tempus's third FDA-cleared AI-ECG tool shows the 510(k) pathway working smoothly, while new pharmacy guidance reveals governance gaps at the point of use.

A clinical monitor showing an AI-annotated lung scan beside a regulatory approval document on a desk.

The Benchmark Gap Inside FDA's AI Change Control Plans

FDA's Predetermined Change Control Plan guidance lets AI devices update without new submissions, but no validated benchmarking standard tells manufacturers where drift becomes risk.

Two diverging paths of light, one narrow and bounded and one diffuse and branching, symbolizing split regulatory tracks for medical AI

Two Speeds of FDA AI Clearance

The FDA's bounded-diagnostic clearances and its generative-AI comment period reveal a widening split in medical AI oversight that regulated buyers must plan around now.