FDA’s AI Medical Device Approvals Aren’t Just Growing — They’re Finally Breaking Out of Radiology

Six AI medical devices got FDA clearance in 2015. Two hundred ninety-five got cleared in 2025. But the real story in the 2026 numbers isn't the growth rate — it's that radiology, which has dominated for a decade, is finally losing share.

On May 31, 2026
0 Comment

FDA Just Redrew the Line for What Counts as a Medical Device — and a Lot of AI Health Products Just Landed on the Free Side

A blood glucose wearable can now be marketed as a general wellness product instead of a regulated medical device — the FDA's January 2026 guidance moves the line for AI health software further than most coverage let on.

On May 24, 2026
0 Comment