15/09/2026
🇺🇸 The FDA has granted De Novo authorization to Queen of Hearts™, our AI ECG model for detecting acute coronary syndrome events, which can include STEMI and STEMI equivalents and require urgent cardiologist activation.
A defining milestone for Powerful Medical—and a new chapter for AI in acute cardiac care.
It is the world’s first FDA-authorized AI ECG solution designed to detect these acute heart attacks, establishing a new FDA device classification for AI ECG models targeting acute, life-threatening cardiovascular events.
Backed by 20+ peer-reviewed studies spanning more than 40,000 patients, Queen of Hearts can now begin its journey into routine clinical care across U.S. health systems.
Thank you to our team, investigators, clinical partners, clinicians, and patients for helping us reach this milestone.
The work now continues: bringing fast, accurate heart attack diagnosis to more patients across EMS, emergency departments, and cardiology.
