Powerful Medical Receives FDA Breakthrough Device Designation for PMcardio STEMI AI ECG Model

Powerful Medical, a leader in AI-driven cardiovascular diagnostics, announces that its PMcardio STEMI AI ECG model has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA). This designation recognizes PMcardio as a breakthrough technology for the detection of ST-elevation myocardial infarction (STEMI) and STEMI equivalents—a life-threatening cardiac condition requiring immediate intervention.

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Powerful Medical Receives FDA Breakthrough Device Designation for PMcardio STEMI AI ECG Model

Every 40 seconds, someone in the US suffers from a heart attack¹, where rapid diagnosis is crucial to saving heart muscle and preventing long-term damage, often leading to higher mortality rates. The ECG remains the primary tool for rapid diagnostics, yet the standard of care often fails to detect heart attacks accurately and timely, resulting in critical delays in treatment. PMcardio is the only solution capable of detecting both STEMI and STEMI equivalents on the ECG—aligning with the emerging emphasis on a paradigm shift towards Occlusion Myocardial Infarction (OMI) diagnosis and bridging a vital gap in early, precise heart attack diagnosis.

“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,” said Robert Herman, MD, PhD, Chief Medical Officer of Powerful Medical. This is especially critical in settings where immediate specialist evaluation isn't available—only 17% of patients presenting to rural centers make it to the catheterization lab in time for intervention.²

Dr. Herman added, “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’s Breakthrough Device Designation provides PMcardio with an expedited review process and close collaboration with the agency on its path toward market authorization. This designation is reserved for technologies that offer significant advantages over existing solutions and address unmet medical needs.

This recognition underscores the FDA’s acknowledgment of Powerful Medical's STEMI AI ECG Model, dubbed “Queen of Hearts”, 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 is a pivotal milestone in our effort to revolutionize heart attack detection and ensure every patient receives immediate, life-saving care,” said Felix Bauer, COO of Powerful Medical. “We’re committed to bringing this life-saving technology to the US, 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 to bring the PMcardio STEMI AI ECG Model to healthcare providers nationwide, serving US public health.

About Powerful Medical

Powerful Medical is a pioneering health technology company specializing in AI-driven cardiovascular diagnostics. Its flagship product, PMcardio, harnesses AI to enhance ECG interpretation, streamline patient triage, and support clinical decision-making. With a mission to bridge the gap between innovation and clinical practice, Powerful Medical is committed to ensuring every patient receives the highest standard of care.

References

1. Tsao, C.W., Aday, A.W., et al. Heart Disease and Stroke Statistics—2023 Update: A Report From the American Heart Association. Circulation. 2023.
   
   
   
   
2. Jollis, J.G., Granger, C.B., et al. Treatment time and in-hospital mortality among patients with ST-segment elevation myocardial infarction. JAMA. 2018–2021.

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PMcardio is the only solution capable of detecting both STEMI and STEMI equivalents on the ECG— bridging a vital gap in early and accurate heart attack diagnostics.