Tag: AI medical devices
FDA roster of cleared AI medical devices passes 1,500
FDA marketing authorizations for AI-powered medical tools have passed 1,500, with oncology among the fastest-growing categories.
Record wave of AI devices wins Medicare add-on payments
A record number of AI devices qualified this year for Medicare's temporary new technology add-on payments, STAT reports.
World-first AI kidney stone surgery robot clears FDA review
Korea's Roen Surgical won FDA 510(k) clearance for Zamenix, an AI-guided flexible ureteroscope robot for kidney stone surgery.