FDA Clears First AI-ECG Model for Acute MI Detection

The Queen of Hearts artificial intelligence (AI)-powered ECG model has received De Novo authorization from the US Food and Drug Administration for the detection of STEMI and STEMI equivalents in patients with suspected acute coronary syndromes, manufacturer Powerful Medical announced last week.

This is “the first FDA De Novo authorization specifically for AI-ECG detection of ACS that requires urgent cardiologist review and intervention,” Robert Herman, MD, PhD, chief medical officer and co-founder of Powerful Medical, told TCTMD via email. “There is no other FDA-authorized AI-ECG model with this specific acute MI indication.”

Importantly, he added, “our intended use goes beyond detection alone and includes triage/prioritization and notification of the appropriate clinician or cardiology team.”

As noted in a company press release, the decision is “establishing a new device classification for AI-ECG models targeting acute, life-threatening cardiovascular diagnoses and underscoring recognition of this technology as a meaningful advance over existing diagnostic tools.”

Use of the Queen of Hearts model, which is deployed through the PMcardio platform for cardiac care coordination, is supported by more than 20 peer-reviewed studies including more than 40,000 patients. Those data show improved sensitivity compared with standard decision-making, reductions in false-positive cath lab activations, and shorter times to treatment, Powerful Medical said.

Last year at TCT 2025, Timothy Henry, MD (The Christ Hospital, Cincinnati, OH), presented results of retrospective registry study demonstrating that use of the model outperformed standard decision-making for the detection of STEMI across three primary PCI networks in the United States; the rate of false-positive activations was 7.9% when using the AI-ECG tool and 41.8% when it was not used. The findings were published simultaneously in JACC: Cardiovascular Interventions.

Speaking with TCTMD after the FDA authorization, Henry said use of Queen of Hearts leads to faster recognition of STEMI and STEMI equivalents (eg, hyperacute T waves and posterior MI), which should shorten times to treatment, and decreases false positives.

“It will be a significant addition to STEMI care in the United States,” he said, adding, “I think this is going to become pretty much standard of care.”

Henry noted that “the process of FDA approval is not always simple or straightforward, so the fact that [Queen of Hearts] is now FDA-approved is a big deal and I think will open the floodgates for use in the United States.”

The AI-ECG model will be particularly helpful at non-PCI centers, Henry predicted, saying that “it allows everybody to have expertise.” He pointed out that there is also a feature that explains why a certain ECG is considered positive for STEMI or a STEMI equivalent, which can help educate physicians. “It will lead to improved EKG recognition as well,” said Henry.

Queen of Hearts was given the FDA’s breakthrough device designation in March 2025 and was included in the agency’s Total Product Life Cycle Advisory Program, which is designed to accelerate development of innovative medical devices. The AI-ECG model previously obtained CE Mark approval in Europe in 2022.

Herman told TCTMD that “we already have multiple US health systems under contract, integrated, and ready to go live—essentially waiting for FDA authorization to flip the switch,” adding that the company is working closely with Henry and others to facilitate speedy uptake in the US.