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FDA approves AI-based software that helps doctors take ultrasound pictures of the heart


The Food and Drug Administration has approved a software product from an artificial intelligence startup that is aimed at making it easier for doctors and other medical professionals to take ultrasound pictures of the heart, also known as echocardiograms.

The technology, developed by San Francisco-based Caption Health, could help more hospitals use the diagnostic test, which currently requires expertise that is in short supply.

“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,” said Robert Ochs, deputy director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “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.

The FDA approved the software through its “de novo” pathway, a process used for brand new medical devices. It will be called Caption Guidance.

Although the software helps medical professionals obtain the echocardiogram image, a trained cardiologist still views the images in order to make any diagnosis.

The data reviewed by the FDA came from two different studies. In one, 50 trained sonographers scanned patients with and without the software and were able to obtain similar images in both settings. In a second study, eight registered nurses who were not trained on using ultrasound used Caption Guidance to obtain images. Five cardiologists reviewed the images, and found that the images and videos were “of diagnostic quality,” the FDA said.

“No patient should have to forgo a potentially lifesaving cardiac ultrasound,” Andy Page, Caption’s CEO, said in a statement. “Through the power of artificial intelligence, Caption Guidance will provide patients with unprecedented access to ultrasound when and where they need it most.”

The caption has raised $18 million to date, the company has previously said. Page was previously a top executive at 23andMe.

A STAT reporter took a look at the new technology in October — using it to take an ultrasound in a matter of minutes. In January, cardiologist Dr. Eric Topol of Scripps Research tweeted that he’d tried the technology for the first time. He seemed enthusiastic.

Written by: Matthew Herper, Senior Writer, Medicine

Published on: FEBRUARY 7, 2020



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