Powerful Medical’s AI heart attack detection model secures FDA approval

Powerful’s Queen of Heart analyses ECG reads to detect STEMI and STEMI-equivalent patterns indicative of acute coronary syndrome. Powerful’s Queen of Heart analyses ECG reads to detect STEMI and STEMI-equivalent patterns indicative of acute coronary syndrome. De novo classification for Powerful Medical’s Queen of Hearts AI model follows breakthrough designation for its PMcardio platform in March 2025. Credit: Natykach Nataliia/Shutterstock.com The US Food and Drug Administration (FDA) has granted de novo authorisation to Powerful Medical’s Queen of Hearts, an AI model for acute coronary syndrome (ACS) detection via electrocardiogram (ECG) analysis. Queen of Hearts is designed for the early identification…

Source: Medical Device Network