Heartsciences receives fda confirmation for 510(k) clearance pathway

Southlake, tx, dec. 05, 2023 (globe newswire) -- heart test laboratories, inc. d/b/a heartsciences (nasdaq: hscs; hscsw) ("heartsciences" or the "company"), an artificial intelligence (ai)-powered medical technology company focused on transforming ecgs/ekgs to save lives through earlier detection of heart disease, today announced that it has received confirmation from the fda to change the clearance pathway for its myovista® wavecg™ device and associated ai-ecg algorithm to a more standard 510(k) submission from the more complex de novo process.
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