Ultromics secures FDA breakthrough device designation for cardiac AI
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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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