FDA Grants Clearance for UltraSight’s AI-Powered Cardiac Ultrasound Technology

Today, UltraSight, a digital health pioneer transforming cardiac imaging through the power of artificial intelligence, announced that it has been granted FDA clearance for its AI-powered ultrasound guidance technology. 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.

With more than 8 million patients admitted to U.S. emergency departments every year with symptoms concerning for heart attack or heart failure according to the Centers for Disease Control and Prevention, access to timely and accurate cardiac ultrasound in the acute care setting can save lives. In addition, approximately 30 million heart disease patients in the U.S. continue to require periodic cardiac monitoring. However, significant bottlenecks within the U.S. healthcare system, coupled with limited resources for training, restrict access to timely and consistent cardiac ultrasound for patients across the country.

“Time to clinical decisions and clinical confidence are key aspects in patient care. This is true for people walking into the Emergency Department with acute heart conditions, or patients requiring ongoing monitoring,” said Roberto Lang, MD, Director of Cardiovascular Imaging at the University of Chicago. “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.”

“The issues arising from the disproportion between the number of heart disease patients and availability of cardiac ultrasound was a key driver for the company’s founding team,” said Davidi Vortman, CEO of UltraSight. “The need to solve this significant disparity is why we applied deep geometrical machine-learning techniques to cardiac ultrasound, and what we found is that AI has the potential to close the skillset gap – empowering medical professionals to successfully acquire timely and accurate cardiac ultrasound images anywhere. With FDA clearance, we can now move forward with bringing our innovation to market and ultimately advancing patient care for the millions in need.”

UltraSight’s solution will enable hospital staff to advance patient triage and treatment with increased efficiency and clinical confidence. It can also increase access to care for chronic heart disease patients by bringing cardiac ultrasound into local communities, potentially increasing patient adherence to critical treatments.

UltraSight’s AI Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the 10 standard views of the heart. The company’s 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.

UltraSight’s software is designed as an accessory for point of care ultrasound systems and is compatible with the Philips Lumify Ultrasound System. 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.

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