FDA sees promise in new AI model for heart attack detection
Powerful Medical, a New York-based artificial intelligence (AI) company, has received the FDA’s breakthrough device designation for its AI model designed to detect signs of an ST-elevation myocardial infarction (STEMI) in electrocardiography results.
The company’s PMcardio STEMI AI ECG model, nicknamed “Queen of Hearts,” identifies STEMI and STEMI-equivalent patterns in a patient’s ECG. It was trained by Stephen W. Smith, MD, an emergency physician at Hennepin County Medical Center and founder of Dr. Smith’s ECG Blog.
“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, said in a statement. “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.”
“We’re committed to bringing this life-saving technology to the U.S., the largest healthcare market in the world,” added Martin Herman, the company’s CEO. “This recognition by the FDA validates the impact of our innovation and brings us closer to transforming emergency cardiac care on a global scale.”
The FDA’s breakthrough device program is designed to help medical devices make it through the approval process faster than they would otherwise. The agency’s representatives work directly with the device manufacturer, for example, and any submissions related to the device will be prioritized.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.