{"data":{"event":{"id":"0d438167-9f73-49f1-88f8-9d03440a8d98","slug":"stat-an-ai-tool-aims-to-catch-harder-to-detect-heart-attacks-in-ekgs-4549bfccd4","title":"FDA authorizes Powerful Medical’s Queen of Hearts EKG heart-attack triage model","short_summary":"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.","full_description":"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).\n\nThis 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.","ledger_type":"benefit","primary_domain_id":"c09546b6-10f8-48df-8347-0c1979416464","event_status":"provisional","event_date":"2026-09-04T00:00:00.000Z","discovery_date":"2026-09-04T00:00:00.000Z","first_published_date":"2026-09-04T00:00:00.000Z","last_reviewed_date":"2026-09-13T00:00:00.000Z","geographic_scope":"United States","affected_population":"U.S. emergency and chest-pain patients once the device is deployed","base_impact_tier":2,"base_score":"3.00","attribution_multiplier":"0.9000","evidence_multiplier":"0.5000","realization_multiplier":"0.7000","durability_multiplier":"0.6000","current_event_score":"0.567000","confidence_level":"medium","score_explanation":"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).","methodology_version_id":"d7881163-fb23-4e71-8625-bac1a8662c0f","original_methodology_version_id":"d7881163-fb23-4e71-8625-bac1a8662c0f","published_at":"2026-09-13T23:09:35.127Z","created_at":"2026-09-13T23:09:35.127Z","updated_at":"2026-09-14T00:14:56.501Z","flags":[],"domain_name":"Medicine & Health","domain_slug":"medicine-health","methodology_version":"0.1"},"contributions":[{"id":"f57c9963-b90c-4a42-a8b1-f2dad374eaf4","event_id":"0d438167-9f73-49f1-88f8-9d03440a8d98","model_id":"3b0e07f0-003f-415a-a22c-9a9597fe0917","role_description":"ECG algorithm authorized to help triage severe and harder-to-spot heart attacks.","attribution_multiplier":"0.9000","credit_share":"1.0000","contribution_score":"0.567000","attribution_rationale":"STAT and the FDA action identify Powerful Medical’s Queen of Hearts as the authorized system. No frontier-lab model is named.","attribution_confidence":"medium","first_used_date":"2026-09-04T00:00:00.000Z","model_version_if_known":null,"review_status":"approved","created_at":"2026-09-14T00:14:56.501Z","model_slug":"queen-of-hearts","model_name":"Queen of Hearts","identity_class":"named_release","is_internal":false,"family_name":"Queen of Hearts","family_slug":"powerful-medical-queen-of-hearts","organization_name":"Powerful Medical","organization_slug":"powerful-medical"}],"sources":[{"id":"798281f9-5eb8-49be-aa6a-0bbf52a7d032","event_id":"0d438167-9f73-49f1-88f8-9d03440a8d98","url":"https://www.statnews.com/2026/09/11/fda-new-ekg-heart-attack-detection-algo-queen-of-hearts/","canonical_url":"https://www.statnews.com/2026/09/11/fda-new-ekg-heart-attack-detection-algo-queen-of-hearts/","source_type":"journalism","publisher":"STAT","author":null,"publication_date":"2026-09-11T00:00:00.000Z","retrieved_at":"2026-09-13T23:09:35.295Z","title":"FDA authorizes Powerful Medical Queen of Hearts EKG heart-attack triage model","excerpt":"A newly approved AI tool can scan EKGs for severe heart attacks and, the company says, for rarer patterns indicating blocked arteries.","content_hash":null,"source_reliability_class":"medium","is_primary_source":true,"is_independent":true,"is_peer_reviewed":false,"archived_url":null,"created_at":"2026-09-13T23:09:35.295Z"}],"claims":[{"id":"d73c81d5-597f-4d50-9704-f4f1f91c4191","event_id":"0d438167-9f73-49f1-88f8-9d03440a8d98","claim_text":"FDA authorizes Powerful Medical’s Queen of Hearts EKG heart-attack triage model","claim_type":"outcome","claim_status":"supported","confidence_score":null,"created_at":"2026-09-13T23:09:35.388Z","updated_at":"2026-09-14T00:14:56.501Z"}],"revisions":[{"id":"53a166cf-65ad-42b0-a641-24c6b438b7bb","event_id":"0d438167-9f73-49f1-88f8-9d03440a8d98","model_id":null,"previous_score":"0.000000","new_score":"0.001000","previous_factors":{},"new_factors":{"evidence":0.1,"base_score":1,"durability":0.5,"attribution":0.1,"realization":0.2},"change_reason":"Auto-published from news ingest.","trigger_type":"news_ingest","trigger_source_ids":null,"reviewer_id":null,"review_status":"published","created_at":"2026-09-13T23:09:35.477Z"},{"id":"de452b2e-11f5-4976-bae3-ca3384e68e1b","event_id":"0d438167-9f73-49f1-88f8-9d03440a8d98","model_id":"3b0e07f0-003f-415a-a22c-9a9597fe0917","previous_score":"0.001000","new_score":"0.567000","previous_factors":{"placeholder":true},"new_factors":{"evidence":0.5,"base_score":3,"durability":0.6,"attribution":0.9,"realization":0.7},"change_reason":"Editorial review of a news-ingest placeholder: rewritten, attributed to a named system, and rescored.","trigger_type":"editorial_review","trigger_source_ids":null,"reviewer_id":null,"review_status":"published","created_at":"2026-09-14T00:14:56.501Z"}],"secondary":[]},"methodology_version":"0.1"}