UltraSight receives FDA approval for AI-based cardiac ultrasound technology.
UltraSight has secured approval from the US Food and Drug Administration (FDA) for its artificial intelligence (AI)-based cardiac ultrasound guidance technology.
With real-time AI guidance software, medical professionals having no sonography experience can acquire cardiac ultrasound images right at the point of care in various settings.
The software is intended for two-dimensional transthoracic echocardiography (2D-TTE) in adult patients, particularly to capture the ten standard views of the heart.
RELATED: Microbot Medical Announces First Steps to Advance CE Mark for Sales in Europe
The FDA approval is based on the company’s pivotal study, which showed that medical professionals having no prior ultrasound experience could obtain diagnostic-quality images with the help of real-time guidance of the ultrasound probe and feedback on the ultrasound image’s quality.
Compatible with the Philips Lumify Ultrasound System, the software can be utilised as an accessory for point-of-care ultrasound systems.
When used along with a compatible device, the AI neural network of UltraSight is designed to predict the position of the ultrasound probe in relation to the heart, based on the ultrasound video stream.
UltraSight CEO Davidi Vortman said: “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.”
