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PMcardio STEMI AI ECG tool earns US FDA breakthrough device designation - Cardiovascular News

Summary by Cardiovascular News
Powerful Medical has been granted breakthrough device designation by the US Food and Drug Administration (FDA) for its PMcardio ST-segment elevation myocardial infarction (STEMI) artificial intelligence (AI) electrocardiogram (ECG) model. PMcardio is 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 …
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Cardiovascular News broke the news in on Wednesday, March 26, 2025.
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