FDA clears AI devices: Tempus ECG tool, kidney stone surgery robot, CapsoCam feature

Sep 28, 2026 · Issue 9 · 3 sources, 3 articles

The FDA has cleared Tempus's AI tool for detecting mitral regurgitation from ECGs. Clearance also went to Zamenix, the first AI-powered kidney stone surgery robot, and to CapsoVision's AI Highlights feature for CapsoCam Plus.

Who is affected and how

doctor

New ECG, endoscopy and surgical AI tools are becoming clinically available.

medtech company

The clearances are model cases for AI devices going through the FDA pathway.

Sources

• FDA Clears Tempus AI Tool to Spot Mitral Regurgitation from ECGsmedical product outsourcing · Sep 28, 2026
• World's First AI-Powered Kidney Stone Surgery Robot, 'Zamenix,' Receives FDA Clearance헬스조선 · Sep 28, 2026
• CapsoVision Announces FDA Clearance of AI Highlights for CapsoCam Plus®globenewswire · Sep 28, 2026

Machine-generated summary based on the titles and excerpts of the source articles. The source article is the authority for the facts. News monitoring, not medical advice: consult a doctor for health decisions.