Ezra Earns FDA Clearance for Prostate Cancer AI Solution

Ezra has received 510(k) clearance from the FDA for its artificial intelligence (AI) software designed to assist radiologists in analyzing prostate magnetic resonance imaging (MRI) scans.

The software measures the sizes of lesions and automatically identifies lesions that require biopsies. It is the first prostate AI software to receive FDA clearance, the company said.

The FDA also cleared the Ezra’s Plexo picture archiving and communications system (PACS) that runs in a browser, allowing radiologists to log onto the Ezra platform and use the AI technology without installing additional software.