Caption Health Receives Expediated Clearance for AI-Guided Cardiac Ultrasound Tool

After an expediated, 25-day review, the U.S. Food & Drug Administration (FDA) has cleared an update to an existing Caption Health artificial intelligence (AI)-guided medical imaging acquisition system, making it easier for front-line providers to perform diagnostic-quality cardiac ultrasounds.

Called Caption Guidance, according to a company statement, this system provides more than 90 types of real-time instructions and feedback, as well as visual prompts to help users – who might not have years of ultrasound experience – make specific transducer movements that can optimize the capture of high-quality images needed for diagnosis.

“Caption AI provides clinicians with the ability to quickly and accurately perform potentially life-saving ultrasound exams where and when they are needed most,” said Andy Page, Caption Health chief executive officer. “We are proud to assist those on the front lines of this pandemic who are risking their lives to care for patients.”

This Caption Guidance update, which is part of the existing Caption AI software platform, includes 88-percent more types of guidance, improved algorithm performance, and optimized workflow, according to company information. It gives providers who do not have specialized echocardiography training the ability to capture images at the point-of-care, both reducing the risk of COVID-19 transmission and conserving the use of personal protective equipment.

The accelerated FDA review was prompted, company officials said, by requests from various clinicians in hospitals nationwide, detailing the need for a tool that would facilitate the rapid assessment of cardiac function, reduce personnel risk exposure, and maximize the limited resources found in hospital emergency room and intensive care units.

“At Northwestern Medicine, we believe AI-based guidance for cardiac ultrasound acquisition will equip our front-line providers to perform these exams with limited training,” said Akhil Narang, M.D., a Northwestern Medicine cardiologist., in a statement. “This will have a significant impact in our response to COVID-19 while minimizing exposure for our sonographers.”