Real IntelligenceReviewIndependent Clinical Evaluation
Back to Atlas

Cardiovascular imaging

EchoGo Heart Failure

Ultromics

Analyzes a routine echocardiographic view to flag patients who may have heart failure with preserved ejection fraction.

Designed for

Cardiologist and echocardiography team

Care setting

Hospital and cardiac imaging center

Specialty

Cardiology, Echocardiography

Public evidence assessedReviewed August 31, 2026

Our assessment

Bottom line

EchoGo Heart Failure has FDA-reviewed diagnostic evidence supporting an adjunctive role in identifying possible HFpEF from routine echocardiography. Independent prospective evidence on workup, treatment changes, false-positive investigation, and outcomes is still developing.

Based on public sources. RIR did not independently test this product. This is not an endorsement or recommendation.

What the evidence supports

Reviewed sources establish a cleared diagnostic aid for identifying patients with HFpEF in a defined echo workflow.

What remains uncertain

Performance across local acquisition protocols, patient subgroups, and the effect on diagnosis and treatment outcomes requires review.

How it was studied

EchoGo Heart Failure has FDA 510(k) records describing software and clinical validation for identifying patients with HFpEF from routine echocardiography. Public materials report testing on real-world cases and comparison with defined clinical reference assessments.

Product facts

Intended use
Provide augmentative AI analysis to support physician identification of HFpEF from eligible echocardiograms.
Represented version
FDA-cleared EchoGo Heart Failure; deployed version requires confirmation
Regulatory context
EchoGo Heart Failure is FDA 510(k) cleared as a diagnostic aid and received Breakthrough Device designation.

Sources reviewed

3 public sources represented in this evidence profile.

FDA 510(k) summary for EchoGo Heart Failure 2.0RegulatoryEchoGo Heart Failure product overviewOfficial productUltromics FDA clearance announcementOfficial documentation
For clinical and investment reviewEvidence context and questions for deeper review

Evidence source base

FDA-reviewed and developer-associated evidence. Independent prospective implementation evidence remains a priority.

Important limitation

Retrospective diagnostic performance does not establish current local accuracy, calibration, effect on specialist workup, treatment changes, or patient outcomes.

Questions to ask

  1. 01Which patients and image views are eligible?
  2. 02How are positive signals incorporated into diagnostic workup?
  3. 03What is current-version performance outside study sites?
Return to AtlasHow RIR evaluates evidence