FDA clears Powerful Medical's Queen of Hearts EKG AI for STEMI

The FDA has granted de novo authorization to Powerful Medical for Queen of Hearts, an AI model that reads a standard EKG and flags heart attacks, including the harder-to-see occlusion patterns that conventional ST-elevation criteria can miss. Fewer than 10 devices per year clear via that pathway, STAT reports.

In a retrospective U.S. registry study of over 1,000 patients across three emergency heart attack networks (Beth Israel Deaconess, UC Davis, and UTHealth Houston), Queen of Hearts identified 92% of true heart attacks on the first EKG versus 71% with standard triage. The false-alarm rate fell from approximately 42% to 8%. The model was developed with input from Stephen W. Smith, an emergency physician at Hennepin County Medical Center in Minneapolis.

Robert Herman, Powerful Medical's chief medical officer and co-founder, described the clearance as "the first FDA De Novo authorization specifically for AI-ECG detection of ACS that requires urgent cardiologist review." Timothy D. Henry, director of clinical research at The Christ Hospital in Cincinnati, pointed to transfers from smaller and rural hospitals "where only 17% currently receive timely treatment" as the group most likely to benefit.

Two of the AI experts we follow shared the STAT piece the day it landed.

Powerful Medical also secured an authorized Predetermined Change Control Plan, which lets it modify the model post-market within a defined scope. Queen of Hearts already carries European CE mark approval and received the FDA's breakthrough device designation in March 2025.