The FDA has cleared Queen of Hearts, Powerful Medical’s ECG model for spotting heart attacks, including occlusive blockages that lack classic ST-elevation signs. The de novo ruling opens the way for wider US use of PMcardio, the platform that runs the model, the US-Slovakia company said.
Queen of Hearts reached European patients through CE marking in 2022. Last year the model logged upward of 120,000 detections of acute MI. Care arrived sooner in over half of those cases, the company says. Its evidence file includes over 20 papers and randomized trials with more than 40,000 patients combined. The published comparisons show about twice the sensitivity of standard care and as few as one-fifth the false positives.
Many US patients still miss the treatment window because triage is slow, chief medical officer Robert Herman argues. Co-founder Felix Bauer expects the authorization to move real-time ECG interpretation to the first medical contact.
PMcardio previously received FDA breakthrough device designation in March 2025. The clearance gives emergency teams a second reader aimed at the subtle ECG patterns behind many missed myocardial infarctions, a category where standard criteria are known to underperform.
