#FDA

J&J's Lung-Robot AI Was Cleared by the FDA. The Release Contains No Efficacy Number.

A 510(k) clearance requires substantial equivalence to something already on the market, not evidence that it works. This is the third launch on the same platform in eighteen months.

3h ago

A white robotic bronchoscopy system on a wheeled cart, with a display screen mounted above two articulated arms

Healthcare AI

The FDA Cleared a Rebuilt Contraception Algorithm Without a Single New Trial Result

Natural Cycles needed a fresh 510(k) submission for this model change. The effectiveness figures in the announcement belong to the product it replaces.

Jul 28, 2026

A person lying down and holding a smartphone in both hands, a cycle-tracking app open on the screen

Healthcare AI

FDA Clears a Wave of AI Tools for Brain MRI Scans

New 510(k) clearances for brain-tumor and metastasis software from Neosoma and Cercare Medical add to radiology's dominance of FDA-approved medical AI.

Jul 4, 2026

FDA Clears a Wave of AI Tools for Brain MRI Scans