Powerful Medical’s Queen of Hearts ACS AI ECG Model has received FDA De Novo authorization, an AI tool that detects ECG findings indicative of urgent acute coronary syndrome, including STEMI and equivalents, to alert clinicians to suspected cases.

The FDA clearance accelerates deployment of PMcardio, Powerful Medical’s AI-driven cardiac care coordination platform, enabling faster integration into routine U.S. clinical care.

Building on a prior Breakthrough Device designation from March 2025, the program now sits under a new FDA device category for AI-based ECG models targeting acute, life-threatening cardiovascular conditions, with plans to deploy across the United States via PMcardio.

Leadership emphasizes enabling fast, accurate heart-attack diagnosis at first medical contact and addressing diagnostic delays that can miss treatment windows.

Queen of Hearts has demonstrated higher sensitivity and fewer false positives in extensive data, including randomized trials with over 40,000 patients across four continents, showing roughly double the sensitivity and up to fivefold fewer false positives than standard care.

More than 20 peer-reviewed studies, including large randomized trials, support Queen of Hearts’ performance—roughly twice the sensitivity, up to fivefold fewer false positives, and faster pathways to cardiology consultation and potential catheterization.

CEO Martin Herman notes the goal of delivering fast, accurate heart-attack diagnosis for patients wherever they present, leveraging De Novo status to scale adoption.

Contextual materials reference the companies involved and related press materials, framing PMcardio within a broader medtech news cycle.

In Europe, the technology has CE marking and detected over 120,000 heart attacks in 2025, contributing to reduced treatment times.

The Queen of Hearts system addresses limitations of standard ECG interpretation that can miss acute heart attacks, with European data showing significant detection and reduced treatment times in many cases.

Industry context includes other medtech news, such as Implicity’s $40 million growth funding to scale AI-driven cardiac monitoring globally and leadership changes at TransMedics and Edwards Lifesciences awards, reflecting a dynamic sector.

Powerful Medical highlights that PMcardio is already in use by over 100,000 clinicians worldwide, underscoring broad access to fast, accurate heart-attack diagnosis.