HeartBeam (BEAT) disclosed earlier today that it received a “Not Substantially Equivalent” letter from the Food and Drug Administration related to the company’s 510(k) application for its 12-Lead Electrocardiogram Synthesis Software. “The Company stands behind its clinical data and will be working with the FDA to come to a resolution,” it added. HeartBeam said it is also evaluating launching its 3D ECG system, which received FDA 510(k) clearance in December 2024. Shares of HeartBeam are down 63%, or $1.06, to 62c in midday trading.
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