UltraSight announced today that it received FDA clearance for its AI-powered ultrasound guidance technology.
Tel Aviv, Israel-based UltraSight designed its real-time AI guidance software to assist in the acquisition of cardiac ultrasound images. It can help medical professionals without sonography experience at the point of care in multiple settings. UltraSight says it allows for more widespread heart disease detection, providing patients with easier access to cardiac monitoring.
“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.”
More about the UltraSight AI-powered technology
The company said its solution enables hospital staff to advance patient triage and treatment with more efficiency and clinical confidence. It could also increase access to care for chronic heart disease patients by bringing cardiac ultrasound to local communities. This may increase patient adherence to critical treatments, UltraSight said.
FDA clearance covers use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients. It specifically grants authorization for the system’s use in the acquisition of the 10 standard views of the heart. Clinical data demonstrated that, with real-time guidance of the ultrasound probe and feedback on image quality, medical professionals without prior ultrasound experience can acquire diagnostic-quality images.
UltraSight designed its software as an accessory for point-of-care ultrasound systems. It has compatibility with the Philips Lumify ultrasound system. When paired with a compatible device, UltraSight’s underlying AI network predicts the position of the ultrasound probe. It predicts this position relative to the heart based on the ultrasound video stream. The software then guides the user on maneuvering the probe to capture diagnostic-quality cardiac images.