According to New York–based Powerful Medical, the AI-powered model is meant to identify ECG findings suggestive of urgent acute coronary syndrome (ACS). The goal is to get urgent notifications to clinicians of suspected cases. According to Powerful Medical, the FDA nod for Queen of Hearts is accelerating U.S. deployment of PMcardio — an AI-driven cardiac care coordination platform built for health system.
“This milestone reflects our mission to ensure every patient has access to fast, accurate heart attack diagnosis, regardless of where they present,” Powerful Medical CEO Martin Herman said in a news release. “With FDA De Novo authorization in place, we can scale adoption and bring this technology into routine clinical care across the United States.”