NEW YORK, March 24, 2025 – Powerful Medical, a prominent player in AI-driven cardiovascular diagnostics, announced today that its PMcardio STEMI AI ECG model has been awarded Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).
This designation signifies PMcardio as a groundbreaking technology designed to detect ST-elevation myocardial infarction (STEMI) and its equivalents – a critical cardiac condition demanding immediate intervention.
Every 40 seconds in the United States, someone experiences a heart attack. Rapid diagnosis is crucial to minimizing heart muscle damage and long-term complications, which often lead to increased mortality rates. While the electrocardiogram (ECG) remains the primary tool for swift diagnostics, the current standard of care frequently fails to accurately and promptly detect heart attacks. This can result in significant delays in treatment.
PMcardio distinguishes itself as the sole solution capable of detecting both STEMI and its equivalents on the ECG. This aligns with the rising emphasis on a shift towards Occlusion Myocardial Infarction (OMI) and addresses a vital gap in early, precise heart attack diagnosis.
“For two decades, life-saving treatments have existed for heart attack patients, yet too many still do not receive the urgent care they require due to diagnostic delays and inefficient triage,” stated Dr. Robert Herman, MD, PhD, Chief Medical Officer of Powerful Medical. He further emphasized the critical need in settings lacking immediate specialist evaluation, noting that only 17% of patients presenting to rural centers reach the catheterization lab in time for intervention.
Dr. Herman added, “By equipping physicians and allied providers with an AI-powered tool for rapid and accurate STEMI detection, available around the clock, we can effectively address this gap, ensure timely treatment, and significantly improve patient outcomes, often preventing avoidable deaths.”
The FDA’s Breakthrough Device Designation grants PMcardio an expedited review process and close collaboration with the agency as it moves toward market authorization. This designation is reserved for technologies that offer significant advantages over existing solutions and fulfill unmet medical needs. This recognition underscores the FDA’s acknowledgment of Powerful Medical’s STEMI AI ECG Model, also known as “Queen of Hearts”. The model aims to set a new standard in frontline heart attack detection and triage, ultimately enhancing care quality, accelerating treatment decisions, and saving lives through earlier and more accurate diagnosis.
“FDA Breakthrough Device Designation represents a pivotal milestone in our mission to revolutionize heart attack detection and ensure every patient receives immediate, life-saving care,” said Felix Bauer, COO of Powerful Medical. “We are committed to bringing this life-saving technology to the U.S., the largest healthcare market in the world. This recognition by the FDA validates the impact of our innovation and brings us closer to transforming emergency cardiac care on a global scale,” added Martin Herman, CEO.
With this designation, Powerful Medical not only works closely with the FDA on market approval but also gains improved access to CMS reimbursement mechanisms.This will enable the PMcardio STEMI AI ECG Model to be available to healthcare providers nationwide, thereby serving U.S. public health.
For additional information about PMcardio and its innovative technology, please visit www.powerfulmedical.com.
About Powerful Medical
Powerful Medical is a pioneering health technology company specializing in AI-driven cardiovascular diagnostics. Its flagship product, PMcardio, utilizes artificial intelligence to enhance ECG interpretation, optimize patient triage, and support clinical decision-making. The company’s primary goal is to bridge the gap between technological innovation and clinical practice, ensuring that every patient receives the best possible care.
