UltraSight’s AI-Powered Cardiac Ultrasound Technology Cleared by FDA

July 27, 2023—UltraSight, an Israel-based digital health company focused on cardiac imaging using artificial intelligence (AI), announced that it has been granted FDA clearance for its AI-powered ultrasound guidance technology. Previously, UltraSight’s real-time guidance software for cardiac ultrasound has received CE Mark approval in the European Union and United Kingdom Conformity Assessed marking.

According to the company, the UltraSight real-time AI-guidance software can assist medical professionals without sonography experience in acquiring cardiac ultrasound images at the point of care in multiple settings, allowing for more widespread detection of heart disease and providing patients easier access to cardiac monitoring.

UltraSight’s AI guidance software is indicated for use in two-dimensional transthoracic echocardiography for adult patients, specifically in the acquisition of the 10 standard views of the heart. The software is designed as an accessory for point of care ultrasound systems and is compatible with the Lumify ultrasound system (Philips).

The company explained that when paired with a compatible device, UltraSight’s underlying AI neural network predicts the position of the ultrasound probe relative to the heart, based on the ultrasound video stream, and guides the user on maneuvering the probe to capture diagnostic quality cardiac images.

UltraSight noted that its submission for FDA clearance was based on its landmark pivotal study which demonstrated that with real-time guidance of the ultrasound probe and feedback on the quality of the ultrasound image, medical professionals without prior ultrasound experience can acquire diagnostic quality images. The company announced the findings from the study in November 2022.

Roberto M. Lang, MD, who is Director of Cardiovascular Imaging at the University of Chicago in Chicago, Illinois, served as Principal Investigator of the study.

“Time to clinical decisions and clinical confidence are key aspects in patient care,” commented Dr. Lang in the company’s press release. “This is true for people walking into the emergency department with acute heart conditions, or patients requiring ongoing monitoring.”

Dr. Lang continued, “Ultrasound is a predominant tool in patient diagnosis but its user-dependent functionality and subjectivity in image quality assessment have been hurdles in providing care for heart patients in multiple care settings. UltraSight’s real-time AI guidance is a gamechanger for diagnostic efficiency and experience. Now, with regulatory clearance, medical professionals and patients alike can benefit from this transformative cardiac imaging solution.”