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An advanced algorithm that looks for signs of heart failure in five-second voice recordings has received the FDA's breakthrough device designation.

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The finding could signal that the brain has the potential to heal itself in the long-term after a stroke. 

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Back in 2019, the FDA issued a warning about the use of paclitaxel-coated devices when treating peripheral artery disease. The agency took back that warning in 2023, but it appears to have made a significant impact on patient care. 

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FDA Commissioner Robert Califf, MD, explains the U.S. is spending the most on healthcare of any country, but has poorer outcomes than other western nations. He said healthcare reform is needed to change that course. #Healthdisparities #healthequity

FDA Commissioner Robert Califf, MD, explains the need for hospitals to perform quality assurance checks on clinical artificial intelligence to ensure these technologies don't "drift" from what was originally cleared by the FDA.
 

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An advanced algorithm that looks for signs of heart failure in five-second voice recordings has received the FDA's breakthrough device designation.