Powerful Medical

Organization · Startup · SK · 1 item since Sep 2026

Deals & regulation

Sep 9
Authorized by U.S. Food and Drug Administration

Models & products

Products: Queen of Hearts

Trends

FDA authorizations extend clinical AI into new specialties and LLMs

Items

Sep 9
FDA authorizes Queen of Hearts AI-ECG
The first De Novo authorization for AI-ECG detection of STEMI and STEMI equivalents creates a new device class for acute cardiac diagnoses; registry data show 7.9% false-positive cath-lab activations with the tool versus 41.8% without.