Ultromics’ EchoGo Amyloidosis Receives the US FDA’s Breakthrough Device Designation to Detect Cardiac Amyloidosis
- The US FDA has granted Breakthrough Device Designation for Ultromics’ EchoGo Amyloidosis, an AI-enhanced platform that detects cardiac amyloidosis by using AI to analyze echocardiograms
- EchoGo Amyloidosis platform is intended to be included within the company’s EchoGo Platform (developed in conjunction with various clinical collaborators and supported by Janssen). The company is also currently working on regulatory submissions for the US while the device could receive clearance for commercialization by early 2024
- Additionally, EchoGo Heart Failure also received Breakthrough Device Designation in 2022 and marketing authorization in 2023
Ref: PRNewswire | Image: Ultromics
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