AI-assisted cardiac ultrasound guidance software receives De Novo clearance

Caption Health's tool instructs non-expert medical staff on how best to produce high-quality diagnostic images in real time.
By Dave Muoio
04:38 pm

The first artificial intelligence-enabled cardiac ultrasound software has received De Novo marketing authorization, the FDA announced today. Developed by Caption Health, the Caption Guidance tool guides medical professionals through a heart disease diagnostic test that normally requires an ultrasound expert.

“Echocardiograms are one of the most widely-used diagnostic tools in the diagnosis and treatment of heart disease,” Robert Ochs, deputy director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a statement. “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.”

According to the agency, the software is now indicated for use in adult patients for the acquisition of standard views of the heart from different angles. It’s currently compatible with a Teratech Corporation-produced diagnostic ultrasound system, and could be used with other ultrasound imaging systems with similar specifications.

According to Caption Guidance, the tool guides practitioners in real time on how to place and move the scanner to produce the best quality image. The software records and stores the highest quality images from each scanning session, and assists analysis with automatic automatic calculation of the ejection fraction — although the final assessment and diagnosis is still conducted by the cardiologist.

The agency said that it reviewed data from two independent studies of the software. The first of these had 50 sonographers scan patients with and without the tool, and found that both settings yielded comparable image quality. The second had eight registered nurses use the software to collect echocardiography images, the quality of which were then assessed by five cardiologists who found them to be of appropriate diagnostic quality.


Heart diseases are the leading killer in the US, and according to the CDC account for one in every four deaths among men and women. Early detection is the first step in preventing serious episodes or managing a long-term condition, meaning that a tool expanding the number of medical staff able to initiate diagnostic imaging could go a long way toward cutting down on new cases.

Further, Caption Health’s De Novo is the latest in a growing number of AI-based tools being cleared to scale diagnostic care and reduce the burden among overworked specialists.

“This is especially important because it demonstrates the potential for [AI] and machine learning technologies to increase access to safe and effective cardiac diagnostics that can be life-saving for patients,” Ochs said.


The past few years has seen the FDA clear dozens of algorithms and clinical decision support (CDS) tools, having just recently released a revised version of its draft guidance on the latter in September. Within the area of cardiovascular diagnostics specifically, health technology firm Ultromics received a 510(k) for its EchoGo Core system in November while digital stethoscope maker Eko picked up its own clearance for an atrial fibrillation and heart murmur detection algorithm just a few weeks ago.

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