Omega Medical Grabs FDA Clearance for AI Imaging System

The FDA granted 510(k) clearance for Omega Medical’s artificial intelligence-powered FluoroShield, an imaging system that reduces x-ray dosage.

The device defines regions of interest based on where the operator is focused and uses autocollimation — an optical technique that reflects a beam back into the system — to improve image quality.

Omega Medical claims that the device is the first of its kind in that it actually reduces radiation dose to patients and staff instead of simply managing it.