Company Spotlight: Clarius Ejection Fraction AI - Automating Cardiac Scans at the Bedside — AI in Medicine - curated summaries making complex issues easy to understand

We unpack the FDA 510(k) summary for the Clarius Ejection Fraction AI, a machine learning tool that automates left ventricular ejection fraction measurements directly on handheld ultrasound probes. The hosts explore the clinical validation data, the performance metrics compared to expert human reviewers, and the implications of the software's Predetermined Change Control Plan for future AI updates. This episode highlights what the clearance means for clinicians at the bedside and the limitations inherent in the retrospective testing.

Key points

Clarius Ejection Fraction AI is an assistive tool cleared for semi-automatic measurement of left ventricular ejection fraction on adult patients using specific Clarius ultrasound scanners.
In a retrospective study of 279 exams, the AI demonstrated an Intraclass Correlation Coefficient of 0.78 when compared to the mean of human reviewers, whereas human reviewers scored between 0.54 and 0.67 when compared to each other.
The clinical verification dataset was drawn from multiple geographic locations, but no clinical or sociodemographic information such as age, gender, or clinical diagnosis was available.
Images of inadequate quality and subjects where the Ejection Fraction AI model failed to generate a measurement were excluded from the performance testing comparisons.
The FDA clearance includes a Predetermined Change Control Plan (PCCP) allowing the company to modify data input sources, training hyperparameters, post-processing steps, and model architecture without a new 510(k) submission, provided they follow strict risk mitigation testing.

Source: FDA 510(k) summary K253593: Clarius Ejection Fraction AI (Clarius Mobile Health) - U.S. Food and Drug Administration, 2026

This episode is an AI-generated conversation summarising a public document; the hosts' voices are synthetic. It is for information only and is not medical advice. Always refer to the original source.

Company: Clarius Mobile Health (clarius.com) · Product: Clarius Ejection Fraction AI · FDA 510(k) K253593

Full transcript: https://ai-in-medicine-podcast.vercel.app/episodes/company-spotlight-clarius-ejection-fraction-ai-automating-cardiac-scan-772da0