Tel Aviv, ISRAEL – July 27, 2023 – 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.”

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