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BioWorld - Thursday, April 30, 2026
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Home » FDA clears 510(k) for Echo IQ’s aortic stenosis SaMD
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FDA clears 510(k) for Echo IQ’s aortic stenosis SaMD

Oct. 9, 2024
By Tamra Sami
The U.S. FDA gave the 510(k) green light to Echo IQ Ltd.’s Echosolv AS for its AI-enabled software as a medical device to be used as a decision support aid in detecting severe aortic stenosis.
Medical technology Regulatory Digital health Artificial intelligence Cardiovascular Asia-Pacific Australia U.S. FDA

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