FDA Clears First AI to Aid Heart Failure Detection During Routine Check-ups
DAIC
APRIL 3, 2024
doi: 10.1136/bmjhci-2022-100718 FDA 510(k) Summary, K233409 Bachtiger, P., for detection of LVEF below 40%, 84.8% sensitivity, and 69.5% specificity when deployed on over 1,050 patients across multiple real-world settings. BMJ Health & Care Informatics, 30:e100718.
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