February 07, 2020
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FDA authorizes marketing of software that uses artificial intelligence for cardiac diagnostics

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The FDA granted Caption Health Inc. authorization to market its Caption Guidance software, which is intended to guide medical professionals through cardiac ultrasound image acquisition, according to an FDA release.

The Caption Guidance software is an accessory to compatible diagnostic ultrasound systems and, according to the release, uses artificial intelligence to obtain pictures of the heart that are of “acceptable diagnostic quality.” The software is intended for 2D transthoracic echocardiography for adult patients, particularly for standard views of the heart from different angles.

“Echocardiograms are one of the most widely used diagnostic tools in the diagnosis and treatment of heart disease,” Robert Ochs, PhD, deputy director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the release. “Today’s marketing authorization enables medical professionals who may not be experts in ultrasonography, such as a registered nurse in a family care clinic or others, to use this tool. This is especially important because it demonstrates the potential for artificial intelligence and machine learning technologies to increase access to safe and effective cardiac diagnostics that can be life-saving for patients.”

According to the release, the Caption Guidance software was created using machine learning, which trained it to differentiate between acceptable and unacceptable image quality. The AI user interface offers prescriptive guidance on how to move the ultrasound probe to obtain standard echocardiographic images and video clips of diagnostic quality. It offers real-time feedback on potential image quality, auto-captures video clips and automatically saves the best video clip obtained from a specific view.

The FDA assessed data from two independent studies for the device application. According to the release, results from both studies demonstrated the software allowed registered nurses to obtain echocardiography images and videos of diagnostic quality.

 

Reference:

www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-cardiac-ultrasound-software-uses-artificial-intelligence-guide-user