This FDA-Cleared AI May Spot a Hidden Coronary heart Assault Your Physician Misses
The new AI-powered device is known as the ‘Queen of Hearts.’ Here’s how it can help save lives.
A new AI-powered device just received clearance to help paramedics detect heart attacks that they may have otherwise missed.
The Food and Drug Administration issued a rare classification for the STEMI AI ECG Model from New York-based medical technology company Powerful Medical. Referred to as “the Queen of Hearts,” this AI model can look at electrocardiogram (ECG) readings from a patient with chest pain, and identify acute arterial blockages that precipitate the most serious types of heart attacks. The technology has the potential to accelerate the time between diagnosis and care for heart attack patients, as well as reduce the rate of false positives.
For the last 20 years, life-saving treatment exists
“For the last 20 years, life-saving treatment exists for heart attack patients, yet far too many still don’t receive the urgent care they need due to delays in diagnosis and inefficient triage,” Robert Herman, a physician and the Chief Medical Officer of Powerful Medical, said in a statement from last year. “By equipping physicians and allied providers with an AI-powered tool for accurate and immediate STEMI detection, available around the clock, we can bridge this gap, ensure timely treatment, and improve patient outcomes, often preventing avoidable deaths.”
The FDA granted the Queen of Hearts ”De Novo” classification, which provides a path for clearance of devices—or in this case algorithms—that differ substantially from devices the FDA previously approved or cleared. Stat News was the first to report the development, and noted that the classification is relatively rare—fewer than 10 AI devices receive it annually. The algorithm had previously received “breakthrough” designation, which will ease its path toward applying for supplemental Medicare payments. That, more flexible approach (which will sunset in 2028) allows Medicare beneficiaries to access innovative, yet expensive tech, according to separate reporting from Stat News.
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The Queen of Hearts’ value lies in its ability to give first responders, who are typically paramedics and ER doctors, the type of expertise needed to best triage cardiac patients. Coronary artery blockages can be diagnosed by the type of pattern, called ST-segment elevation myocardial infarction (STEMI) that they cause a heart to make on an ECG scan. The AI model can quickly identify those. Where the model truly shines is in identifying heart attacks in people who have blocked arteries, but are not meeting classic STEMI criteria on their first ECG, which can be as many as 50 percent of patients. Incorrect diagnosis can delay treatment by about four to five hours, according to Powerful Medical, potentially costing patients their lives.
These [STEMI] equivalents are not something that you
“These [STEMI] equivalents are not something that you can teach a paramedic during a weekend course,” Martin Herman, CEO of Powerful Medical, told Stat News, adding that although cardiologists are more likely to have training to identify these less common ECG patterns, it is usually paramedics and ER doctors who are seeing patients first.
Aside from those patients who have atypical ECG results, but are still experiencing life-threatening heart attacks, there are also false positives. Because these heart attacks are so serious, many triage systems will err on the side of safety, mobilizing teams of specialists to rush in and prep a patient for surgery. That results in false alarms—and added expenses—about 25 to 40 percent of the time. Houston-based Memorial Hermann-Texas Medical Center is planning a pilot program to test whether the algorithm results in cost-savings, Stat News reported.
Heart disease is the leading cause of death in the U.S., causing an estimated one in three deaths in 2023, according to the Centers for Disease Control. There is, however, some good news. A study published in the Journal of the American Heart Association in 2025 found that heart attack deaths have fallen about 90 percent from 1970 through 2022, in part thanks to medical innovations. In fact, the field for ECG analysis is already crowded, both with legacy software and AI-powered innovations that promise to detect a variety of anomalies from atrial fibrillation to genetic heart conditions, Stat News reported.
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