FDA grants de novo clearance to Powerful Medical’s AI tool for detecting severe heart attacks on EKGs

The U.S. Food and Drug Administration issued a de novo classification for Powerful Medical’s AI algorithm that analyzes electrocardiograms to identify severe heart attacks. This clearance allows the tool to be used in clinical settings to help triage patients presenting with chest pain.

The algorithm, described as the "Queen of Hearts," scans a standard 10‑second EKG and flags patterns that suggest a blocked artery or a high‑risk heart attack. The company says the system can detect harder‑to‑spot events that traditional analysis might miss.

Unlike the majority of AI medical devices that receive 510(k) clearance, a de novo classification is granted to only a few products each year and requires more extensive clinical evidence. This signals the FDA’s confidence in the tool’s performance and safety data.

If widely adopted, the AI could speed decision‑making in emergency departments, directing patients to the appropriate level of care more quickly and potentially improving outcomes for those experiencing acute cardiac events.