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Ultromics EchoGo

by Ultromics  ·  GB

Last verified

FDA-cleared AI on echocardiograms that flags heart failure with preserved ejection fraction and screens for cardiac amyloidosis.

Visit Ultromics EchoGo (opens in new tab)Read our methodology

At a glance

Pricing
No public price.
HIPAA
Attested
SOC 2
Not disclosed
EHRs
—
Founded
—
HQ
GB
On this page

Independent score  ·  By our public rubric

42/100Competitive

Editorial rating 3.0 / 5

How it’s computed →
  • Regulatory & Compliance
    24/28

    FDA cleared (6 510(k) clearances on record)

  • Clinical Integration
    0/6.6

    No EHR integrations listed

  • Evidence Strength
    0/26

    No peer-reviewed coverage

  • Vendor & Market
    8.4/18

    Mid-tier funding and adoption

  • Sentiment & Transparency
    2.5/5

    Pricing on request, no public amounts

▸ Show all 11 dimensions

Regulatory & Compliance

  • FDA clearance18/18

    FDA cleared (6 510(k) clearances on record)

  • HIPAA / SOC2 / BAA6/10

    Partial attestation (one of HIPAA / SOC2 / BAA)

Clinical Integration

  • EHR integrations (count)0/4

    No EHR integrations listed

  • Top-3 EHR coverage (Epic / Oracle / Athena)0/2

    None of the top-3 EHRs covered

Evidence Strength

  • Peer-reviewed papers0/18

    No peer-reviewed coverage

  • RCT / meta-analysis / systematic review0/8

    No RCT, meta-analysis, or systematic review

Vendor & Market

  • Funding & adoption signal8/12

    Mid-tier funding and adoption

  • Years in market0/6

    Founded year not recorded

Sentiment & Transparency

  • Pricing transparency3/5

    Pricing on request, no public amounts

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

FDA-cleared AI on echocardiograms that flags heart failure with preserved ejection fraction and screens for cardiac amyloidosis.

No public price. HIPAA-attested.

Evidence record

FDA decisions
Show 1 more
Verification
  • Score computed November 2, 2026, method 1.2.0
  • Review written November 2, 2026
Cite this record

MedAI Verdict, Ultromics EchoGo record, https://medaiverdict.com/tools/ultromics, version November 2, 2026

Change history
View every change to this record

Bottom line

Ultromics EchoGo is AI on echocardiograms, bought by echo labs and cardiology departments. EchoGo Heart Failure flags findings suggestive of heart failure with preserved ejection fraction (HFpEF) from a single apical four-chamber view, and EchoGo Amyloidosis screens adults 65 and older with heart failure for cardiac amyloidosis. Cardiology groups with an HFpEF or amyloid pathway fit. The older Core and Pro lines for quantification and stress echo do not appear on the vendor's site.

What does each product cover?

EchoGo Heart Failure has two versions on the FDA list, 1.0 in November 2022 and 2.0 in September 2024. The indication is a diagnostic aid for HFpEF in adults over 25, from an apical four-chamber view with an ejection fraction of 50% or higher. The product page states 90.3% sensitivity and 86.1% specificity in clinical evaluation, citing K240013. A March 28, 2025 press release announced HFpEF probability scoring.

EchoGo Amyloidosis received 510(k) clearance as K240860 on November 15, 2024, as a screening aid with EchoGo Heart Failure as its primary predicate. The product also holds a Breakthrough Device Designation, a separate status that is not a clearance.

FDA records list six Ultromics decisions in all, from November 2019 to November 2024. The other three belong to the older Core line (quantification of cardiovascular function) and Pro line (an adjunct to diagnostic stress echocardiography). The vendor's home page counts four FDA clearances, and whether Core and Pro are still sold is not stated.

What does the evidence show?

A 2026 JACC Heart Failure paper (PMID 42965535) tested EchoGo HF in the MESA cohort of 2,544 people for early HFpEF and reported an AUROC of 0.77 against 0.70 for the H2FPEF score. A 2025 Nature Communications paper (PMID 40133291) externally validated an AI HFpEF model, EchoGo Heart Failure v2, against H2FPEF and HFA-PEFF in 240 cases and 256 controls. Vendor involvement is not verified for either paper.

A July 22, 2026 release about an American Heart Association AI Assessment Lab report on EchoGo HF is vendor-run and not peer reviewed. The vendor claims more than 500,000 real-world cases processed.

Price and reimbursement

No public price. The site's call to action is "Talk with an EchoGo expert." CPT code 0932T and APC 5743, with a CMS update dated December 12, 2024, are reimbursement facts attached to EchoGo Heart Failure on the product page and not a price. According to the vendor, findings return to PACS and EMR within about 20 minutes of the study, with no on-premise infrastructure. Its Trust Centre lists GDPR, HIPAA, ISO 13485:2016 and ISO/IEC 27001:2022.

The verdict

EchoGo fits a cardiology service with an HFpEF or amyloid question on echo it already acquires. For HFpEF, the published support for early disease is the 2026 MESA result of 0.77 AUROC against 0.70 for the H2FPEF score. Amyloidosis, cleared in November 2024, is the newer of the two products.

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.

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

What deploys cleanly

Carries FDA 510(k), ISO 13485:2016, ISO/IEC 27001:2022, HIPAA (vendor-stated, Trust Centre) per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.

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