The AI ECG Cardiology Market After Queen of Hearts: Who the De Novo Clearance Actually Benefits
Dr. Dereck Mush, MD, MBA
Powerful Medical
Clinical AI company behind Queen of Hearts, the first FDA authorised AI ECG model for detecting heart attacks.
What they do
Powerful Medical builds PMcardio, an AI platform that reads standard 12 lead ECGs. Its Queen of Hearts model received FDA De Novo authorisation in September 2026 for detecting acute coronary syndrome, after validation in more than 40,000 patients across over 20 studies.
The record
- Vertical
- Cardiovascular
- Sub-segment
- Cloud ECG analysis
- Product type
- Software as a medical device
- Stage
- Series A
- Headquarters
- Bratislava, Slovakia
- Region
- Europe
- Founded
- 2019
- Total funding
- $9M raised
Notable investors: Zero Gravity Capital, Crowdberry, Lighthouse Ventures, CB Investment Growth.
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