---
title: "FDA authorizes Queen of Hearts AI to detect hard-to-spot heart attacks on EKGs"
id: "stat-news-0-stat-an-ai-tool-aims-to-catch-harder-to-detect-heart-attacks-in-ekgs"
canonical_url: "https://medichelpline.com/clinical-feed/stat-news-0-stat-an-ai-tool-aims-to-catch-harder-to-detect-heart-attacks-in-ekgs"
content_type: "clinical_feed_article"
specialty: "Cardiology"
source_name: "STAT News"
source_url: "https://www.statnews.com/2026/09/11/fda-new-ekg-heart-attack-detection-algo-queen-of-hearts/?utm_campaign=rss"
published_at: "2026-09-11T08:30:00.000Z"
evidence_level: "Verified Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# FDA authorizes Queen of Hearts AI to detect hard-to-spot heart attacks on EKGs
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/stat-news-0-stat-an-ai-tool-aims-to-catch-harder-to-detect-heart-attacks-in-ekgs
- **Specialty:** [Cardiology](https://medichelpline.com/clinical-feed/cardiology.md)
- **Primary Source:** STAT News
- **Source URL:** [Original Journal Publication](https://www.statnews.com/2026/09/11/fda-new-ekg-heart-attack-detection-algo-queen-of-hearts/?utm_campaign=rss)
- **Published At:** 2026-09-11T08:30:00.000Z
- **Evidence Rating:** Verified Feed
## Executive GIST (TL;DR)
- The Food and Drug Administration issued a de novo authorization to Powerful Medical’s **Queen of Hearts** algorithm to assist triage of patients with chest pain by analyzing a 10-second **EKG**. The reporting notes this de novo path is uncommon and typically requires more clinical evidence than the 510(k) route. - The algorithm aims to identify heart attacks that are harder to detect on standard EKG interpretation, complementing existing AI cleared to screen for arrhythmias and structural heart disease. - The most severe heart attacks involve complete coronary artery blockage and are typically identified by **ST-segment elevations** on an EKG; those patients need rapid transfer to a cath lab to restore blood flow. - STAT’s report highlights the potential role of AI to help clinicians identify myocardial infarction during acute presentations, but detailed performance metrics, study design, datasets, and operational details were not reported in the source article. - Fewer than 10 devices receive de novo classification from the FDA each year, underscoring that this pathway is reserved for devices with novel indications or where greater evidence is required. - The source places this authorization in the context of a broader wave of clinical AI cleared for cardiovascular uses, including arrhythmia detection and models predicting risk of sudden cardiac arrest. - The STAT piece is behind a STAT+ paywall; the article provides an overview but does not publish the full clinical validation, intended use population, comparator standards, or real-world deployment guidance in the accessible excerpt. - Clinicians should note that while the algorithm is positioned for triage support, the STAT report does not provide operational recommendations, integration details, or regulatory labeling from the FDA decision text in the quoted excerpt.
## Clinical Analysis & Structured Key Points
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Test your knowledge with our new weekday mini crossword [ Start solving ](https://www.statnews.com/stat-mini-crossword/) [STAT Plus](https://www.statnews.com/stat-plus/)[Health tech](https://www.statnews.com/category/health-tech/) # An AI tool aims to catch harder-to-detect heart attacks in EKGs ## FDA authorizes Powerful Medical’s Queen of Hearts algorithm to help triage heart attacks * [Manage alerts for this article](https://www.statnews.com/my-account/edit/#emails) * Email this article * [Share this article](https://www.statnews.com/2026/09/11/fda-new-ekg-heart-attack-detection-algo-queen-of-hearts/?utm_campaign=rss) ![](https://www.statnews.com/wp-content/uploads/2026/09/AdobeStock_910347045-645x645.jpeg) Adobe ![](https://www.statnews.com/wp-content/uploads/2021/02/katie-p-avatar-small-80x80.png) By [Katie Palmer](https://www.statnews.com/staff/katie-palmer/) Sept. 11, 2026 Health Tech Correspondent ![](https://www.statnews.com/wp-content/uploads/2021/02/katie-p-avatar-small-80x80.png) [Katie Palmer](https://www.statnews.com/staff/katie-palmer/) 1. [](https://x.com/KatieMPalmer "X") katie.palmer@statnews.com Katie covers the impact of health technology on patients, clinicians, and businesses. Her stories explore the price tag of clinical AI, digital health at the FDA, and the boom in direct-to-consumer telehealth. Confidential tips can be sent on Signal at palmer.01. A flurry of artificial intelligence algorithms have promised to help identify heart conditions early. By analyzing an electrocardiogram, a common 10-second test of the heart’s activity, AI has been cleared to screen for common arrhythmias and [structural heart conditions](https://www.statnews.com/2026/06/23/pathway-labs-echonext-ai-tool-heart-disease-detection/), and algorithms in development aim to pinpoint patients at highest risk of [sudden cardiac arrest](https://www.statnews.com/2026/06/24/artificial-intelligence-model-cause-of-sudden-cardiac-death/). While many of those models are focused on early diagnosis and prevention, AI also might help a patient when they’re having a heart attack. Last week, the Food and Drug Administration issued a rare [de novo classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250044) to a model from Powerful Medical that aims to help triage patients to the right care when they’re having chest pain. The vast majority of AI devices go to market through the FDA’s 510(k) clearance pathway; fewer than 10 each year receive de novo classification, which typically requires more clinical evidence. Advertisement The most severe kind of heart attack occurs when a coronary artery, which supplies blood to the heart, is completely blocked off. Those patients need to get to a cardiac catheterization lab as soon as possible to open up the blockage and restore oxygen to the heart. On an EKG, doctors can identify these kinds of myocardial infarctions from their characteristic “ST-segment elevations.” [![STAT+](https://www.statnews.com/wp-content/themes/stat/images/stat-plus-logo.svg)](https://www.statnews.com/stat-plus/) To read the rest of this story subscribe to STAT+. 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