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Benefit Ledger · provisional · Medicine & Health

FDA authorizes Powerful Medical’s Queen of Hearts EKG heart-attack triage model

In early September 2026 the FDA issued a de novo classification for Powerful Medical’s Queen of Hearts algorithm, which reads electrocardiograms to help triage chest-pain patients, including occlusions that lack classic ST-segment elevation.

Tier 2 NotableMethodology 0.1
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Current score

+0.57

3 base · Notable (tier 2 of 5, 3 pts)
× 0.9000 attribution · Primary causal contribution
× 0.5000 evidence · External expert evaluation
× 0.7000 realization · Independently validated or deployed
× 0.6000 durability · Medium-term
Event-level product before credit split: 0.57

FDA de novo authorization of a heart-attack triage aid is notable (tier 2), not a proven lives-saved outcome. Attribution is to Queen of Hearts (0.90). Evidence is an FDA de novo plus independent reporting (0.50). Realization is authorization, not universal deployment (0.70).

What happened

In early September 2026 the U.S. Food and Drug Administration issued a de novo classification for Powerful Medical’s Queen of Hearts algorithm, which reads 12-lead electrocardiograms to help triage chest-pain patients, including occlusion myocardial infarctions that lack classic ST-segment elevation. STAT reported the authorization on 11 September 2026. De novo classification is uncommon for AI devices and typically requires more clinical evidence than a 510(k). This is a regulatory authorization of a diagnostic aid, not a measured reduction in mortality. The underlying model is a specialized clinical ECG system, not a frontier language model.

Model attribution

+0.57

Queen of Hearts

ECG algorithm authorized to help triage severe and harder-to-spot heart attacks.

STAT and the FDA action identify Powerful Medical’s Queen of Hearts as the authorized system. No frontier-lab model is named.

Attribution 0.9000 · Credit share 100% · Powerful Medical

Claims

  • FDA authorizes Powerful Medical’s Queen of Hearts EKG heart-attack triage model

    outcome · supported

Sources

primary sources

Revision history

  • 13 Sep 2026 · 0.00 → 0.00

    Auto-published from news ingest.

  • 14 Sep 2026 · 0.00 → 0.57

    Editorial review of a news-ingest placeholder: rewritten, attributed to a named system, and rescored.

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