UltraSight's AI Guidance Assessment Software Technology Studied to Enable Novice Cardiac Sonographers

November 28, 2022—UltraSight, an Israel-based digital health company focused on cardiac imaging through artificial intelligence (AI), announced new findings from a landmark pivotal study of the UltraSight guidance and quality assessment software, which is currently under FDA review with 510(k) clearance pending.

According to the company, the results show that the technology allows medical professionals with no previous sonography experience to accurately perform echocardiographic examinations and acquire high-quality diagnostic images of the heart.

The multicenter study was conducted at the University of Chicago in Chicago, Illinois; Aurora St. Luke’s Medical Center in Milwaukee, Wisconsin; and the Sheba Medical Center in Tel HaShomer, near Tel Aviv, Israel.

Professor Roberto M. Lang, MD, Director of Noninvasive Cardiac Imaging Laboratory at the University of Chicago, is the principal investigator of the study.

As summarized in UltraSight's press release, investigators evaluated two-dimensional transthoracic echocardiography images that were acquired using UltraSight’s AI real-time guidance software by nine residents and registered nurses, none of whom had cardiac ultrasound experience. The study was conducted using the Lumify ultrasound device (Royal Philips).

The company explained that the 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 how to maneuver the probe to acquire images of diagnostic quality.

After undergoing a 1-day training course, the novice ultrasound users scanned 240 cardiac patients and acquired 10 standard echocardiography views. The patients were also scanned by a professional sonographer, without using the software, and each examination was blindly evaluated by a panel of five United States board-certified cardiologists who graded the exams for their diagnostic quality and anatomic elements.

The company stated that the results confirm that the cardiac examinationss performed by the novice ultrasound users permitted the following assessments with successful rates:

• Left ventricular size (99.2%)
• Left ventricular function (99.6%)
• Right ventricular size (93%)
• Presence of significant pericardial effusion (100%)

The results also confirm that using UltraSight’s AI guidance, novice ultrasound users can acquire diagnostic quality images of the 10 standard echocardiographic views in 68–94% of examinations, similar to the results announced in May 2022 from a pilot study conducted earlier in the year.

"The quality of the exams conducted by both the novice users and professional cardiac sonographers were remarkably comparable," commented Prof. Lang in the company's press release. "After analyzing the results, it is apparent that healthcare professionals without prior sonography training can follow the guidance offered by the software and capture diagnostic quality ultrasound images of patients’ hearts."

In August 2022, the company announced it received CE Mark approval for its AI guidance software for cardiac ultrasound, which it is now available in the European Union to institutions interested in using it for clinical trials.