What is Queen of Hearts?

An AI model in the PMcardio platform that reads 12-lead ECGs and flags findings suggestive of urgent acute coronary syndrome, including STEMI and STEMI equivalents.

Is Powerful Medical's AI authorized in the United States?

Yes. The FDA granted De Novo authorization to Queen of Hearts in September 2026, and the company announced it on 15 September 2026.

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Medical AI company

Powerful Medical

Powerful Medical is a medical technology company founded in 2017 that builds PMcardio, an AI platform that reads 12-lead ECGs from a photo or digital file. Its Queen of Hearts model, which flags ECG signs of urgent heart attacks including STEMI equivalents, received FDA De Novo authorization in September 2026 after CE marking in Europe.

Last reviewed 28 Oct 2026

Facts at a glance

Type	AI ECG diagnostics company
Founded	2017
Main product	PMcardio platform with the Queen of Hearts AI ECG model source
FDA status	De Novo DEN250044 for Queen of Hearts, decision dated 3 September 2026 source
Users	More than 100,000 clinicians and over 2.5 million ECGs analysed, the company says source
US billing code	Category III CPT code 1139T, effective 1 January 2027 source

Questions people ask

What is Queen of Hearts?: An AI model in the PMcardio platform that reads 12-lead ECGs and flags findings suggestive of urgent acute coronary syndrome, including STEMI and STEMI equivalents.
Is Powerful Medical's AI authorized in the United States?: Yes. The FDA granted De Novo authorization to Queen of Hearts in September 2026, and the company announced it on 15 September 2026.