Powerful Medical Wins First FDA Nod for AI-ECG Tool

Powerful Medical has won FDA De Novo authorization for Queen of Hearts, an AI model that reads a standard 12-lead ECG for signs of an acute heart attack and flags it for urgent cardiologist review. Announced 15 September 2026, it is the first FDA authorization of an AI-ECG tool built specifically to catch STEMI and STEMI-equivalent heart attacks — the kind that classic ST-elevation criteria miss — and it creates a new device classification that other AI-ECG makers can now clear against.

Reading the ECG past ST elevation

Powerful Medical’s Queen of Hearts is a deep-learning model trained on full ECG waveform morphology rather than the fixed ST-elevation threshold that has defined heart-attack triage for decades. That distinction is the point: a meaningful share of true coronary occlusions — so-called STEMI-equivalents, or occlusion myocardial infarctions — do not produce the ST-elevation pattern classic criteria look for, and get missed or delayed on a first read. Queen of Hearts sits inside the company’s PMcardio platform, which the company says interprets ECGs for dozens of cardiac findings across prehospital, emergency-department and cardiology settings; the newly authorized model is scoped specifically to acute coronary syndrome.

Stephen W. Smith, MD, an emergency-medicine professor at Hennepin Healthcare in Minneapolis and author of Dr. Smith’s ECG Blog, has been publicly credited by the company as a clinical collaborator who helped train and validate the model against angiographically confirmed outcomes — the ground truth Powerful Medical says its training data is built on, rather than the ECG pattern alone.

Why 92 percent beats first instinct

01

Higher catch rate, fewer false alarms

In the U.S. registry study cited in the FDA submission, Queen of Hearts flagged 92% of true heart attacks on the first ECG against 71% for standard triage, while cutting false-alarm cath-lab activations from roughly 42% to roughly 8% — the two numbers a cath lab actually schedules around.

02

A pathway that creates the category

De Novo authorization is reserved for devices with no predicate to clear against; FDA grants it to fewer than ten AI devices a year. Powerful Medical is first through this specific door, and the classification it created is now open to competitors via the faster 510(k) route.

03

Three years of paid clinical use behind it

Queen of Hearts has carried a CE mark under the EU’s Medical Device Regulation since March 2023. The company says that European deployment caught more than 120,000 heart attacks in 2025 — a real-world base the FDA submission could draw on that a first-time device rarely has.

Queen of Hearts in four figures

92%of true heart attacks caught on the first ECG, versus 71% for standard triage

~42% → ~8%false-alarm cath-lab activation rate, standard care versus Queen of Hearts

<10AI devices FDA authorizes via the De Novo pathway in a typical year

120,000+heart attacks the company says its model caught across Europe in 2025

Figures from the 15 September 2026 announcement and the company’s published clinical data.

What a De Novo grant actually creates

De Novo is the pathway FDA uses when a device is novel enough that no predicate exists to clear it against under a standard 510(k) — the agency instead evaluates it directly and, if it grants authorization, writes a new regulation and product classification for the category. That classification is now public property: any company with an AI-ECG model aimed at the same acute-coronary-syndrome indication can seek the faster 510(k) route against it, rather than filing its own De Novo. Powerful Medical’s own path here ran through a Breakthrough Device Designation for the same model, granted 25 March 2025, which entitled it to more frequent, structured FDA interaction as the submission came together.

The company frames the milestone as a global-access story as much as a regulatory one: Queen of Hearts has been running in European hospitals since its CE mark in March 2023, expanding to 15 additional European markets that July, before the FDA submission that produced this week’s authorization.

“This milestone reflects our mission to ensure every patient has access to fast, accurate heart attack diagnosis, regardless of where they present.” Martin Herman, Chief Executive Officer and co-founder, Powerful Medical — 15 September 2026 announcement

A crowded AI-ECG field, one clear gap

FDA has cleared or authorized a growing list of AI tools that read a standard ECG for signs of disease, but none of them for the specific job Queen of Hearts now holds. That gap — not the presence of competitors — is the real story: acute heart-attack triage was, until this authorization, the one major AI-ECG use case with no FDA-authorized answer at all.

Cardiac AI’s widely different price tags

$2.78B → $14.22B

Global AI-in-cardiology market, 2026 to 2034, as forecast by Fortune Business Insights; The Business Research Company’s narrower cardiac AI monitoring and diagnostics estimate is shown for comparison.

2026 (AI in cardiology)$2.78B

2026 (cardiac AI monitoring)$2.71B

2030 (cardiac AI monitoring)$6.94B

2034 (AI in cardiology)$14.22B

Sources: Fortune Business Insights, AI in Cardiology Market · The Business Research Company, Cardiac AI Monitoring and Diagnostics Global Market Report

Regulatory News outlook

We expect acute-MI triage tools like Queen of Hearts to open a distinct segment inside AI-in-cardiology spending worth roughly $700 million a year by 2034, well short of a market of its own but large enough to justify the competitors this authorization’s new classification now invites.

How we got here: Fortune Business Insights values the broader AI-in-cardiology market at $14.22 billion by 2034; acute coronary syndrome accounts for a small minority of cardiology AI use cases, so we apply a 5% share of that total — $14.22B × 0.05 ≈ $711M — as a rough, recomputable floor for the acute-MI triage segment specifically.

Four cleared algorithms, four different jobs

Product	Pathway	What it flags	Acute heart attack detection?
Queen of Hearts (Powerful Medical)	De Novo, September 2026	Acute coronary syndrome, incl. STEMI-equivalents	Yes — its authorized indication
Viz HCM (Viz.ai)	De Novo, 2025	Hypertrophic cardiomyopathy	No — a different chronic condition
ECG-AI Low EF (Anumana)	510(k)	Low ejection fraction, a heart-failure marker	No — a chronic risk marker, not an acute event
Cardiologs (Philips)	510(k), 2017	Atrial fibrillation and other arrhythmias on ambulatory monitoring	No — rhythm screening, not acute triage

From each company’s own regulatory filings and announcements; not a head-to-head clinical comparison.

From a Bratislava trial to a US first

Seven years to De Novo

1. 2019

   Powerful Medical founded

   Founded in Bratislava, Slovakia by Martin Herman and Robert Herman, MD, PhD, to build AI-ECG diagnostics.

2. January 2022

   First MDR clinical trial in Slovakia

   The company says it launched the first medical-device clinical trial run under the EU’s new Medical Device Regulation, with insurers Union and Dôvera.

3. September 2022

   €6.2 million seed round

   Closed with Venture To Future Fund, CB ESPRI Impact One, bpd partners and angel investors.

4. March 2023

   CE mark, EU launch

   PMcardio launches as a CE-marked Class IIb device under EU MDR, with a UK launch the same month.

5. March 2024

   €7.5 million from the EU Innovation Council

   A €2.5 million grant plus €5 million equity investment to fund continued development.

6. 25 March 2025

   FDA Breakthrough Device Designation

   Granted for the PMcardio STEMI AI-ECG model, ahead of the De Novo submission.

7. 15 September 2026

   FDA De Novo authorization

   Queen of Hearts becomes the first FDA-authorized AI-ECG model for acute heart-attack detection.

8. Ahead

   US deployment

   The company says the authorization accelerates US rollout of PMcardio; it has not published a launch date.

What the US rollout still needs to show

• Commercial launch: no published U.S. launch date; the company has said the authorization accelerates deployment rather than starting it immediately.
• New competitors: the classification Powerful Medical created is now open to any AI-ECG maker willing to clear a 510(k) against it for the same acute-coronary-syndrome indication.
• Independent replication: the 92%-versus-71% and 42%-to-8% figures come from a single cited U.S. registry study; hospital systems adopting the tool will generate their own real-world numbers, as Europe already has.

What is not yet public: the device’s De Novo number in FDA’s own database, which the agency typically indexes within days of a grant, and the exact U.S. commercial and reimbursement plan. We will update this page when FDA’s record and the company’s launch details are published.

Frequently asked questions

What did FDA authorize for Powerful Medical?

A De Novo authorization for Queen of Hearts, the ACS AI-ECG Model inside the company’s PMcardio platform, which analyzes a standard 12-lead ECG to flag findings suggestive of an acute heart attack — including ST-elevation myocardial infarction (STEMI) and STEMI-equivalents that do not meet classic ST-elevation criteria — for urgent cardiologist review. FDA authorized it on 15 September 2026, creating a new device classification other AI-ECG makers can now use.

Is this the same as an FDA clearance?

No. De Novo authorization is a separate pathway FDA uses for novel, low-to-moderate-risk devices that have no prior equivalent on the market to clear against under a 510(k). It is rare: fewer than ten AI-based devices a year receive it. Once granted, other companies can seek a faster 510(k) clearance against the classification it creates.

How accurate is Queen of Hearts?

In a U.S. registry study of more than 1,000 patients cited in the FDA submission, the model flagged 92% of true heart attacks on the first ECG, against 71% caught by standard triage, while cutting false-alarm cath-lab activations from roughly 42% to roughly 8%.

Is Queen of Hearts available in the United States yet?

The authorization clears the regulatory path; the company has not published a U.S. commercial launch date. Queen of Hearts has been CE-marked and sold in Europe since March 2023, where the company says it was used to catch more than 120,000 heart attacks in 2025.