Ultromics secures FDA breakthrough device designation for cardiac AI

2021 09 14 17 40 3190 Heart Artificial Intelligence Ai 400

Ultromics has secured breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its artificial intelligence (AI)-enhanced platform for detecting cardiac amyloidosis.

The platform, EchoGo Amyloidosis, uses AI to analyze echocardiograms and identify the presence of cardiac amyloidosis.

EchoGo Amyloidosis is a module within the company's EchoGo Platform. Ultromics developed it using data from several clinical collaborators and with support from Janssen Biotech, part of the Janssen Pharmaceutical companies of Johnson & Johnson.

Ultromics is preparing regulatory submissions for the platform for the U.S. market and expects that it could be cleared for commercialization in early 2024, it said.

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