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
Related News:- Ultromics’ EchoGo Heart Failure as a Breakthrough Device Receives the US FDA’s Clearance for the Detection of Heart Failure with Preserved Ejection Fraction
