AI model that reads heart scans becomes the first of its kind authorized by the FDA to catch heart attacks that standard readings can miss.
Every 40 seconds, someone in the US has a heart attack. The tool doctors reach for first is the electrocardiogram (ECG), which has been around for more than a century and is still the fastest way to check what’s going on inside a patient’s heart. There’s a catch that doesn’t come up enough outside cardiology circles, though: standard interpretation of that test misses a meaningful chunk of acute heart attacks, particularly a category called STEMI equivalents, patterns that mean an artery is blocked without showing the textbook signs doctors are trained to catch right away. Missed reads mean delayed treatment, and in a condition where minutes decide how much heart muscle survives, that delay is often the whole ballgame.
Powerful Medical, based in New York, announced on 4 September that the US Food and Drug Administration (FDA) granted its AI-powered ECG model, called Queen of Hearts, De Novo authorization, the agency’s pathway for devices genuinely novel enough that they don’t fit an existing category. First FDA authorization ever given to an AI ECG tool built specifically to catch acute heart attacks, including the equivalents that are easy to miss [1].
What’s actually happening under the hood
It’s not replacing a cardiologist. Queen of Hearts runs inside a platform called PMcardio, which threads AI-assisted ECG interpretation through the earliest points of contact a patient has with the health system: a paramedic in an ambulance, an ER nurse, the first physician on the chart and hands that assessment off to cardiology faster than a manual read usually allows.
The system reads standard 12-lead ECGs and flags patterns consistent with a heart attack in progress, aiming to close the gap between when a patient’s heart starts struggling and when a cardiologist actually finds out.
More than 20 peer-reviewed studies back the model, according to the company, including randomized controlled trials in major cardiovascular journals, covering upwards of 40,000 patients across four continents. That published data has Queen of Hearts catching roughly twice as many true heart attacks as standard-of-care interpretation, cutting false positives by as much as fivefold, and getting patients to treatment quicker.
It’s already got a track record in Europe. Following CE-marking there, Powerful Medical says the tool detected more than 120,000 heart attacks in 2025, and in over half those cases, helped speed up treatment.
Martin Herman, the company’s CEO and co-founder, treated the FDA decision as much an access story as a technical one.
“This milestone reflects our mission to ensure every patient has access to fast, accurate heart attack diagnosis, regardless of where they present,” he said. “With FDA De Novo authorization in place, we can scale adoption and bring this technology into routine clinical care across the United States.”
Robert Herman, the company’s Chief Medical Officer and co-founder, was blunter about what’s actually at stake for patients.
“Many heart attack patients in the United States still miss the window for life-saving treatment due to delays in diagnosis and inefficient triage,” he said.
Felix Bauer, the company’s COO and co-founder, added, “With FDA-approved technology now available, we can bridge this gap by bringing accurate, real-time ECG interpretation to the first medical contact.”
Where this fits into the longevity conversation
Cardiac AI tools get filed under acute care pretty reflexively, and it’s easy to see why, but heart disease sits at the center of just about every serious conversation about healthy lifespan. It’s still the leading cause of death worldwide, and unlike most chronic conditions tied to aging, a heart attack can end a life or permanently damage heart function, over the course of an afternoon.
The window between when damage starts and when treatment begins is one of the few places in cardiovascular medicine where a single technology shift can meaningfully change outcomes, mostly by protecting the heart muscle that would otherwise be lost in the hours right after an event starts, rather than by preventing the disease years ahead of time.
PMcardio is already used more than 2 million times a year by over 100,000 clinicians, per the company, linking emergency responders, ER staff and cardiologists into one coordination platform. Queen of Hearts also holds Breakthrough Device Designation and sits in the FDA’s Total Product Life Cycle Advisory Program, and Powerful Medical is treating this authorization less as an endpoint and more as the starting gun for a broader US rollout.
