FDA Grants Breakthrough Device Status to AI Model for Heart Attack Detection

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Powerful Medical has received FDA Breakthrough Device designation for its PMcardio STEMI AI ECG model, designed to rapidly detect signs of ST-elevation myocardial infarction (STEMI) in electrocardiography results.

The AI model, named “Queen of Hearts”, identifies STEMI and STEMI-equivalent patterns in patient ECGs. Developed by Stephen W. Smith, MD, an emergency physician, this tool aims to address delays in diagnosis and triage, ensuring quicker, life-saving interventions for heart attack patients.

Key Highlights:

  • The AI model enables immediate and accurate STEMI detection, available 24/7.
  • The technology aims to bridge gaps in emergency cardiac care, improving patient outcomes and preventing avoidable deaths.
  • The FDA’s Breakthrough Device designation accelerates the approval process, advancing the technology to the U.S. healthcare market.

Powerful Medical’s AI-powered solution promises to revolutionize emergency cardiac care, improving the speed and accuracy of diagnoses.

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