FDA authorizes Powerful Medical's AI ECG model for spotting heart attacks
The FDA granted De Novo authorization to Powerful Medical's PMcardio Queen of Hearts, an AI model that reads 12-lead ECGs for signs of urgent acute coronary syndrome, including STEMI and STEMI equivalents, and alerts clinicians to suspected cases. STAT reported the authorization on September 11 and the company announced it on September 15. The company says the model is backed by more than 20 peer-reviewed studies covering over 40,000 patients, found about twice as many heart attacks as standard care with up to five times fewer false positives, and is already used across more than 150 hospital locations, mostly in Europe.
Why it's notable: Many heart attacks caused by a fully blocked artery don't meet standard STEMI criteria on the ECG. A tool that flags them could get more of these patients to the cath lab faster. De Novo authorizations are rare, and this one creates a new FDA device category for AI ECG models that detect acute, life-threatening heart conditions.