UltraSight AI-Powered Cardiac Ultrasound Gains FDA Nod

UltraSight, a digital health company aiming to transform cardiac imaging through artificial intelligence (AI), has earned U.S. Food and Drug Administration (FDA) clearance for its AI-powered ultrasound guidance technology.
 
UltraSight real-time AI guidance software can help clinicians without sonography experience acquire cardiac ultrasound images at the point of care in multiple settings.
 
“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,” Roberto Lang, MD, Director of Cardiovascular Imaging at the University of Chicago, told the press. “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,” added 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 AI Guidance software is meant for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in acquisition of the 10 standard views of the heart.
 
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.