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AccurECG

by AccurKardia  ·  US

Last verified

FDA-cleared AI software that analyzes ambulatory single-lead ECG recordings for qualified professionals, as an adjunct to review.

Visit AccurECG (opens in new tab)Read our methodology

At a glance

Pricing
No public price. There is no pricing page; the only route is the partner contact form.
HIPAA
Not disclosed
SOC 2
Not disclosed
EHRs
—
Founded
—
HQ
US
On this page

Independent score  ·  By our public rubric

19/100Tracked

Not rated: too little independent evidence yet.

How it’s computed →
  • Regulatory & Compliance
    12/22

    FDA cleared (2 K-numbers on record)

  • Clinical Integration
    0/11.6

    No EHR integrations listed

  • Evidence Strength
    0/30

    No peer-reviewed coverage

  • Vendor & Market
    3/18

    Seed-stage or unfunded

  • Sentiment & Transparency
    1.3/2.5

    Pricing on request, no public amounts

▸ Show all 11 dimensions

Regulatory & Compliance

  • FDA clearance12/12

    FDA cleared (2 K-numbers on record)

  • HIPAA / SOC2 / BAA0/10

    No public HIPAA/SOC2/BAA attestation

Clinical Integration

  • EHR integrations (count)0/6

    No EHR integrations listed

  • Top-3 EHR coverage (Epic / Oracle / Athena)0/5

    None of the top-3 EHRs covered

  • Bidirectional write-back0/1

    No bidirectional write-back documented

Evidence Strength

  • Peer-reviewed papers0/21

    No peer-reviewed coverage

  • RCT / meta-analysis / systematic review0/9

    No RCT, meta-analysis, or systematic review

Vendor & Market

  • Funding & adoption signal3/12

    Seed-stage or unfunded

  • Years in market0/6

    Founded year not recorded

Sentiment & Transparency

  • Pricing transparency1/3

    Pricing on request, no public amounts

Scored November 2, 2026 · Public scoring method v1.2.0

FDA-cleared AI software that analyzes ambulatory single-lead ECG recordings for qualified professionals, as an adjunct to review.

No public price. There is no pricing page; the only route is the partner contact form.

Evidence record

FDA decisions
Verification
  • Score computed November 2, 2026, method 1.2.0
  • Review written November 2, 2026
Cite this record

MedAI Verdict, AccurECG record, https://medaiverdict.com/tools/accurkardia, version November 2, 2026

Change history
View every change to this record

Bottom line

AccurKardia, a New York company, sells AccurECG, a web and API service that analyzes ambulatory single-lead ECG recordings and returns labeled beats, rhythm and heart rate for a qualified professional to review. FDA cleared it twice through the 510(k) route, in June 2023 and December 2025. It suits a cardiac monitoring company that wants beat-level labeling behind its own service, which matches the partners named in the company's news. A cardiology service that wants 12-lead interpretation is not who it addresses.

Which of its products are cleared?

Only AccurECG. The site also shows AK-AVS, an aortic valve stenosis screen, and AK+ Guard, a hyperkalemia detector, and marks both research use only and "Not cleared or approved by the US FDA". AK-AVS received FDA Breakthrough designation in October 2024 and entered the FDA TAP program in June 2026. AK+ Guard received Breakthrough designation in January 2025. A designation is not a clearance.

What do K223013 and K252361 cover?

K223013 was cleared on June 23, 2023 as the AccurECG Analysis System (product code DPS). K252361 followed on December 22, 2025 for version 2.0 under 21 CFR 870.2340, with K223013 as its predicate, so the chain is the company's own. The vendor announced the version 2.0 launch in January 2026.

The FDA summary for K252361 describes server-side software that labels and measures a single-lead recording uploaded through the web or an API. It detects ventricular and supraventricular ectopic beats and reports heart rate and rhythm, for adults 22 and older. It is an adjunct to review by a qualified professional and is not meant for telemetry monitors.

Is there a study of AccurECG?

The only PubMed paper naming the company or AccurECG in its title or abstract is a 2022 JMIR Formative Research study (PMID 36169999). It compared QT and QTc measured by an Apple Watch and processed on the earlier AccurBeat platform with a 12-lead ECG, so it concerns a different product and is vendor-linked. The company's news page cites an aortic stenosis study from February 2026 for AK-AVS, which is not a cleared product. It also reports a 2025 MedTech Breakthrough award for "Best New Technology Solution for ECG".

Funding, partners and price

The FDA record gives the address as 101 Avenue of the Americas, New York. The About page names Juan C. Jimenez as CEO and Mohamed Sadeq Ali as COO among five founders. A company news item announced the final closing of a $2.7 million seed round in June 2023, while third-party totals range from $2.5 million to $6.81 million. The company lists Mayo Clinic Platform Accelerate, NVIDIA Inception and the 2024 MedTech Innovator cohort.

Monitoring-firm partners in its news are HeartBeam (April 2025), Specialized Medical (April 2026) and Wellysis (July 2026). EHR integrations and security attestations are not stated. The only way to get a price is the "Partner With Us" contact form, since the site has no pricing page.

The verdict

The partners named in its news are monitoring firms. Whether version 2.0 is sold to hospitals directly is unanswered, and a clinic that wants a device it can buy off the page has no listing to buy from.

Editorial review last generated November 2, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.

What it costs

All tiers are custom-quoted. The vendor does not publish per-provider list pricing.

TierMonthlyAnnualNotes
EnterpriseNot statedNot statedNo public price. There is no pricing page; the only route is the partner contact form.

Source: vendor pricing page. Last checked November 2, 2026.

What deploys cleanly

Carries FDA 510(k) per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.

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