Powerful Medical's 'Queen of Hearts' AI ECG model wins FDA De Novo authorization

Sep 15, 2026 · Issue 7 · 3 sources, 3 articles

Powerful Medical's AI-based 'Queen of Hearts' ECG model received FDA De Novo authorization on 15 September 2026.

Who is affected and how

doctor

A new, authorized AI ECG tool is entering cardiac diagnostics.

medtech company

The De Novo pathway creates a new product category, which serves as a reference for similar devices.

Sources

• Powerful Medical’s “Queen of Hearts” AI ECG Model Wins FDA De Novo Nodmedical product outsourcing · Sep 15, 2026
• Powerful Medical Receives FDA De Novo Approval for PMcardio "Queen of Hearts," Its AI ECG Model for Detecting Acute Heart Attacksbusiness wire · Sep 15, 2026
• Powerful Medical Receives FDA De Novo Authorization for AI ECG Model Detecting Acute Heart Attacks - News Centerg-medtech.com · Sep 15, 2026

Machine-generated summary based on the titles and excerpts of the source articles. The source article is the authority for the facts. News monitoring, not medical advice: consult a doctor for health decisions.