FDA clears Powerful Medical’s Queen of Hearts AI for urgent ECG heart-attack flags

Powerful Medical said the FDA granted De Novo authorization for Queen of Hearts, its AI ECG model meant to spot findings suggestive of urgent acute coronary syndrome — including STEMI and STEMI equivalents — and urgently notify clinicians. The company is accelerating U.S. rollout of its PMcardio platform around the newly authorized model.

Same-day company primary: FDA De Novo for an AI ECG model aimed at urgent heart-attack patterns that standard STEMI rules often miss — unlocking U.S. health-system deployment of PMcardio around that authorized model.

Powerful Medical, a cardiovascular AI company datelined New York, announced that the U.S. Food and Drug Administration granted De Novo authorization for Queen of Hearts, also called the ACS AI ECG Model. That 15 Sep 2026 company blog is the filing event. De Novo is the FDA path that creates a new device type when no already-cleared predicate exists. These are company claims. This desk did not review the FDA letter.

What the model is designed to do, as the company tells it: identify electrocardiogram — ECG — findings suggestive of urgent acute coronary syndrome, or ACS, which can include STEMI and STEMI equivalents, and urgently notify clinicians of suspected cases. An ECG is the heart’s electrical tracing. STEMI is the classic ST-elevation heart-attack pattern. STEMI equivalents are urgent blocked-artery patterns that lack that classic ST elevation. ACS is the umbrella for urgent blocked-artery heart events. File that job as the company’s. This is assist and notification software, not a diagnosis on its own and not a claim it replaces cardiologists.

Company context on the need: heart attacks remain a leading cause of death; U.S. patients are affected every 40 seconds; the ECG is the primary tool, but standard-of-care interpretation often misses a significant share of acute heart attacks, especially STEMI equivalents. File those lines as Powerful Medical’s. This desk did not audit a registry.

Prior path, still the company’s: Breakthrough Device Designation in March 2025; inclusion in the FDA’s Total Product Life Cycle Advisory Program, or TAP; and De Novo now, which the company says establishes a new device classification for AI ECG models targeting acute, life-threatening cardiovascular diagnoses. File the Breakthrough date, the TAP inclusion, and the new-classification line as the company’s statement — not as FDA label text this desk invented.

Europe context, company figures: after CE-marking — Europe’s market authorization — Queen of Hearts detected over 120,000 heart attacks in 2025 and contributed to reduced treatment times in more than half of those cases. File 120,000 and more-than-half as Powerful Medical’s. This desk did not count those cases or time those treatments.

Evidence base, still company: more than 20 peer-reviewed studies, including randomized controlled trials, spanning over 40,000 patients across four continents. Published data, the company says, show roughly twofold higher sensitivity versus standard of care, up to fivefold fewer false positives, and faster time to treatment. Sensitivity is how often a tool catches a finding that is there. File those study counts and ratios as the company’s. This desk did not rerun the trials and is not naming journals the Sep 15 blog does not name.

Named voices on the company blog: Martin Herman, chief executive and co-founder; Robert Herman, MD, PhD, chief medical officer and co-founder; and Felix Bauer, chief operating officer and co-founder. File the names and titles as the company’s. Their quotes are color only and stay in Sources.

Product path, company: with De Novo in hand, Powerful Medical is accelerating U.S. deployment of PMcardio, an AI cardiac care coordination platform that integrates ECG interpretation across pre-hospital, emergency-department, and cardiology workflows. File that rollout plan as the company’s. This desk did not watch a U.S. install.

Company about-box on the same blog: PMcardio is used by 100,000-plus clinicians who have analyzed more than 2.5 million ECGs; it detects 50-plus ECG findings, including occlusion myocardial infarction, or OMI — a blocked-artery heart-attack pattern the company says conventional STEMI rules miss in over half of cases. File those counts and the OMI line as Powerful Medical’s. This desk did not count the clinicians or the ECGs.

Plain English for the rest of the card: ECG = electrocardiogram, the heart’s electrical tracing. STEMI = classic ST-elevation heart-attack pattern. STEMI equivalents = urgent occlusion patterns that lack classic ST elevation. ACS = acute coronary syndrome, the umbrella for urgent blocked-artery heart events. De Novo = FDA path that creates a new device type when no predicate exists. CE-mark = Europe market authorization. OMI = occlusion myocardial infarction, a blocked-artery heart-attack pattern. TAP = FDA Total Product Life Cycle Advisory Program.

What this is not: Queen of Hearts is device-assist / notification software — a helper that flags findings and notifies clinicians — not autonomous diagnosis, not a drug approval, and not a miracle cure. Do not treat the company’s study summaries as independent Bad Signal verification. This desk is not inventing a 510(k) number, a mortality reduction as an FDA-proven endpoint, or a claim the model replaces cardiologists.

PRIMARY here: Powerful Medical’s 15 Sep 2026 company blog — Tier A company source, not a second-hand wire — plus the same-day Business Wire syndicate of that same company text. The De Novo authorization, the ACS / STEMI / STEMI-equivalent notification job, the every-40-seconds and missed-STEMI-equivalent need lines, the March 2025 Breakthrough and TAP path, the company’s new-classification claim, the Europe 120,000 / more-than-half figures, the more-than-20-studies / 40,000-patient evidence summary, the Herman / Herman / Bauer names, the PMcardio U.S. rollout, and the 100,000-clinician / 2.5-million-ECG about-box are company-attributed. NOT claimed: a 510(k) number, FDA label text this desk invented, cardiologist replacement, mortality cuts as FDA-proven endpoints, a drug approval, independently verified study results, that this desk reviewed the FDA letter, a stock tip, or investment advice. Distinct from the already-filed azmed-azchest-fda-6th, curvebeam-ai-fda-ct-bmd-510k, nvidia-chop-cardiac-monai, inductive-bio-indy-chemistry, tandem-health-100m-series-b, nara-health-14m, and ataraxis-tau-chemo.