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A.I. Heart Ultrasound Software Cleared by FDA

Caption Guidance screen

Screen shot from Caption Guidance software (Caption Health)

10 Feb. 2020. Software guided by algorithms that capture top-quality ultrasound images of the heart is now authorized by the Food and Drug Administration. The agency on Friday cleared Caption Guidance software, made by Caption Health in Brisbane, California, for marketing in the U.S., when used with a specific cardiac ultrasound system.

Echocardiograms use ultrasound that bounces sound waves off the heart to provide a non-invasive method of inspecting a person’s heart working in real time, and can offer conclusive evidence of heart disease such as damage to heart valves. While widely employed by cardiologists, echocardiograms usually require highly trained specialists called sonographers to provide images with acceptable clarity for interpretation by physicians to diagnose heart disease. As a result, echocardiograms are not often found in primary care or emergency settings, despite a continuing high rate of heart disease, responsible for one in four deaths in the U.S.

Caption Guidance helps non-sonographer clinicians operate an echocardiogram to return high-quality ultrasound images of a patient’s heart. The software guides the echocardiogram operator with on-screen instructions for positioning the transducer, the wand that sends out ultrasound signals and captures returning signals, to obtain the best images. Caption Guidance records a video of the entire session with a patient, then automatically provides the best two-second video clips for diagnostics.

In addition, the software calculates a patient’s ejection fraction, the percentage of blood leaving the heart’s left ventricle  each time it contracts, a key indicator of heart function. In December 2018, FDA cleared that part of the software for marketing in the U.S.

Caption Health, known previously as Bay Labs, drives the software with algorithms trained by echocardiogram images of varying quality, to discriminate among different levels and identify top-quality images. FDA based its authorization on two clinical trials, first testing Caption Guidance software with 50 expert sonographers, who returned diagnostic-quality images both with and without the software’s help.

In the second trial, eight registered nurses, but not trained as sonographers, used Caption Guidance to generate echocardiogram images with 240 cardiac patients ranging in size from normal to obese. The results, evaluated by trained cardiologists, show registered nurses can generate echocardiogram images of suitable quality to make diagnostic decisions.

In the trials, Caption Health used its software with an FDA-cleared echocardiogram system made by the Terason division of Teratech Corp. FDA’s clearance covers the use of Caption Guidance only with that system, but the agency says it hopes the software can be extended to other echocardiogram developers with similar specifications.

FDA says its the first software cleared for guiding non-expert health care professionals with ultrasound image capture. The agency authorized the system under its De Novo classification pathway, for new types of low- and moderate-risk devices, where no comparable devices or systems already exist.

Caption Health expects Caption Guidance will be used in point-of-care, intensive care, and emergency settings serving a higher volume of patients with suspected heart diseases. “No patient should have to forgo a potentially life-saving cardiac ultrasound,” says Andy Page, Caption Health’s CEO in a company statement released through PR Newswire. “Through the power of artificial intelligence, Caption Guidance will provide patients with unprecedented access to ultrasound when and where they need it most.”

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