Powerful Medical wins a De Novo for AI that flags heart attacks on a 10-second ECG

MedDevice Startups Staff · Sep 4 · 2 min read · Via STAT

FDA granted Powerful Medical a De Novo under DEN250044 for Queen of Hearts, an AI model that reads a standard 10-second, 12-lead ECG and flags STEMI and STEMI-equivalent patterns. The indication covers early identification of suspected acute coronary syndrome patients who may benefit from early cardiology consultation and early catheterization.

The model sits inside the company's PMcardio platform. It was trained on ECG annotations from Stephen W. Smith, an emergency physician at Hennepin County Medical Center, and it looks at the whole waveform rather than applying ST-elevation thresholds. Powerful Medical was founded in 2020 and runs its evidence program out of Slovakia and the US.

The company took Breakthrough Device designation in March 2025 and already held a CE mark as a Class IIb device under MDR. It cites more than 20 peer-reviewed studies covering over 40,000 patients, reporting roughly twice the sensitivity of standard STEMI criteria with fewer false positives.

Most AI ECG software reaches the US market through a 510(k) against an existing arrhythmia or ECG analysis predicate. Powerful Medical took the slower, evidence-heavier route instead, and it now owns the regulation. The next company making this claim files against Powerful Medical's special controls.

Questions & Answers

What did FDA authorize for Powerful Medical's Queen of Hearts?

FDA granted Powerful Medical a De Novo classification under DEN250044 for Queen of Hearts, an AI model that reads 12-lead ECGs to flag STEMI and STEMI-equivalent patterns. The model runs inside the company's PMcardio platform.

What is the indication for Powerful Medical's Queen of Hearts AI model?

Queen of Hearts is indicated for early identification of suspected acute coronary syndrome patients who may benefit from early cardiology consultation and early cardiac catheterization. It analyzes a standard 10-second, 12-lead ECG.

Did Powerful Medical have FDA Breakthrough Device designation before the De Novo?

Yes. Powerful Medical received FDA Breakthrough Device designation for the PMcardio STEMI AI ECG model in March 2025, ahead of the De Novo granted under DEN250044. The model also holds a CE mark as a Class IIb device under the EU Medical Device Regulation.

← Back to Newly Cleared