UltraSight, a digital health company focused on cardiac imaging, has received the US Food and Drug Administration (FDA) approval for its AI-powered ultrasound guidance technology.
The AI-Guidance software is indicated for two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the 10 standard views of the heart.
The software is designed to help medical professionals without sonography experience to acquire cardiac ultrasound images at multiple point-of-care settings.
It enables hospital staff to advance patient triage and treat chronic heart disease patients using cardiac ultrasound, increasing patient adherence to critical treatments.
UltraSight said that its FDA submission was based on a clinical trial which showed that with real-time guidance of the ultrasound probe enables medical professionals without prior experience to acquire diagnostic quality images.
UltraSight CEO Davidi Vortman said: “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.
“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.”
According to the CDC, more than eight million patients are admitted to emergency departments in the US every year, with symptoms of heart attack or heart failure.
Access to timely and accurate cardiac ultrasound in the acute care setting can save lives.
However, bottlenecks within the US healthcare system, together with limitations for training, restrict access to timely and consistent cardiac ultrasound for patients across the country.
The company said that its software is designed as an accessory for point-of-care ultrasound systems and is compatible with the Philips Lumify Ultrasound System.
When used together with a compatible device, its AI neural network predicts the position of the ultrasound probe relative to the heart and guides its manoeuvring to capture diagnostic-quality cardiac images.
Last month, UltraSight teamed up with EchoNous, a US-based medical equipment manufacturer, to advance cardiac ultrasound.
