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 of suspected ACS patients who may benefit from early cardiology consultation and early cardiac catheterisation. ACS is primarily shorthand for heart attack, but the umbrella term also encompasses conditions like unstable angina that often serve as critical warning signs that a heart attack may happen soon.
While ECG is the primary diagnostic tool, standard of care (SoC) interpretation often fails to detect a significant proportion of acute heart attacks, particularly STEMI equivalents, leading to delays in life-saving treatment, Powerful stated.