Ultromics has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), along with Pfizer and AstraZeneca, for its EchoGo Amyloidosis software.
EchoGo Amyloidosis is an AI screening tool that detects amyloidosis from a single echocardiography clip.
The device is the first of the 55 devices enrolled in the FDA’s Total Product Life Cycle Advisory Program (TAP) to secure marketing authorization, Ultromics said. The TAP Program, set up by the FDA in 2023, expedites patient access to medical devices.
Janssen Biotech and Pfizer supported the development of this software.
