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BioWorld - Sunday, December 22, 2024
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» 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
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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.
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