Healio5d
FDA grants 510(k) clearance to AI Optics’ handheld retinal imaging system
The device is designed to be easy to use and portable. The FDA has granted 510(k) clearance to AI Optics’ Sentinel Camera, a handheld retinal imaging system that captures high-quality images ...
Morningstar26d
Radical Catheter Technologies’ 8F Neurovascular Catheter Receives US FDA 510(k) Clearance, Second for the Best-in-Class Ribbon Technology Platform
Radical Catheter Technologies has received two US FDA 501(k) clearances for the 7F and 8F applications of its novel platform. The 7F Radicalâ„¢ Catheter has neurovascular clearance for both ...
Yahoo Finance13d
AI Optics Receives FDA Clearance, Increasing Patient Access to Retinal Screening
NEW YORK, Jan. 28, 2025 /PRNewswire/ -- AI Optics Inc., an AI-focused medical device company announced today that it has received FDA 510(k) clearance for its Sentinel Camera. This handheld ...