FDA Approves Caption Health’s AI-Powered Cardiac Ultrasound Software

Artificial Intelligence (AI) is often hailed as the future of MedTech and the U.S. Food and Drug Administration’s (FDA) most recent approval is a step in the right direction. Earlier this month, the FDA approved software from medical AI firm Caption Health, which allows medical professionals without specialist training to perform cardiac ultrasounds.

The software is called Caption Guidance, which assists and guides medical professionals such as nurses through the steps of the exam. Cardiac ultrasounds are one of the most common tools used to diagnose heart disease.

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“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,” said Robert Och, FDA Center for Devices and Radiological Health deputy director of in vitro diagnostics and radiological health.

Using machine learning, the two-dimensional transthoracic echocardiography (2D-TTE) software views the heart from various angles and provides real-time feedback on image quality while auto-capturing videos and saving the best clips of certain views.

The FDA awarded the program a de novo approval for use with a Teratech ultrasound system, but it also stated that it will be able to be used with other imaging systems with the proper technical specifications.

The agency assessed data from two different studies, which was conducted by Northwestern Medicine and Minneapolis Heart Institute at Allina Health, in the evaluation of the device application. One study involved 50 trained sonographers who captured similar diagnostic quality images both with and without the assistance of Caption Guidance.

The second study saw eight registered nurses with no prior ultrasound experience evaluate the use of the technology. After a short training course, the nurses then performed ultrasound exams using Caption Guidance on 240 patients. Finally, a panel of expert cardiologists assessed the exams. The nurses successfully acquired measurements of ventricular size and function as well as cases of pericardial effusion, or excess fluid surrounding the heart muscle.

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

The company is already planning where first to deploy the software, casting an eye on emergency rooms, critical care units as well as anesthesiology departments as a priority. Here, patients often require an assessment of chest pains, shortness of breath, and require immediate diagnoses.