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FDA approves Caption Health’s AI-guided imaging system

Published on 10/02/20 at 11:06am

The FDA have given marketing approval for Caption Health’s Caption Guidance and its use in cardiac ultrasound images.

The technology allows healthcare providers with no previous ultrasound experience to capture quality diagnostic images. It is planned to be deployed initially in areas needing acute care including critical care units as well as emergency and anesthesiology departments and will later be expanded to other departments.

Andy Page, Caption Health’s Chief Executive Officer, said: “No patient should have to forgo a potentially life-saving cardiac ultrasound. Through the power of artificial intelligence, Caption Guidance will provide patients with unprecedented access to ultrasound when and where they need it most.”

The FDA’s approval was based on a review of a clinical trial conducted by Northwestern Medicine and Minneapolis Heart Institute at Allina Health. The trial was conducted by nurses, who had no previous ultrasound experience, on 240 patients.

The company said that the trial had reached all four primary endpoints, along with the pre-specified criteria for the study's success by acquiring quality images for specific clinical assessments.

Charles Cadieu, Caption Health co-founder and President, said: “We founded Caption Health to tackle head-on some of the most challenging, intractable problems in medicine. This FDA authorization confirms our unique ability to couple breakthrough technology with robust clinical validation. And we’re just getting started.”

Conor Kavanagh


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