FDA-Cleared AI Device

EchoGo

Ultromics

Automates measurement of cardiac function from echocardiography, including ejection fraction and strain, with modules aimed at detecting reduced ejection fraction and diastolic dysfunction.

At A Glance

Manufacturer
Ultromics
Medical specialty
Cardiology
Clearance route
510(k)
Year authorized
2020 onward
Modality
Echocardiography
Role in workflow
Quantification

Echocardiography has an under-discussed reproducibility problem: the same study measured by two sonographers can produce ejection fractions several points apart, and clinical thresholds sit inside that margin. Automation is attractive here less for accuracy than for consistency.

Where It Is Used

  • Automated ejection fraction reporting
  • Strain analysis without manual tracing
  • Reducing inter-reader variability in serial studies

Limitations Worth Knowing

Automated measurement inherits image quality problems entirely. Poor acoustic windows, foreshortened views, and off-axis planes produce confidently wrong numbers. Automation reduces variability without necessarily reducing bias.

Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.

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