Israeli Cardiac Ultrasound Software Gets FDA Clearance

An AI-powered cardiac ultrasound technology has received FDA clearance, according to its Israeli maker.

The real-time UltraSight software guides medical staff in capturing heart scans, even if they don’t have sonography experience, according to the company of the same name. The technology can help detect heart disease and expand access to cardiac monitoring to more providers.

The real-time diagnostic tool can be carried out at the point of care in a broad range of settings. The solution could reduce the bottlenecks caused by limited training or fewer resources available for periodic cardiac ultrasounds.

The AI-enabled diagnostic tool can make heart monitoring more accessible to more communities, which could encourage more patients to follow cardiac treatment plans.

The AI guidance software works in conjunction with a two-dimensional transthoracic echocardiography (2D-TTE) scan for adults, acquiring 10 standard views of the heart. A landmark study it conducted showed that medical staff without prior ultrasound experience could acquire quality images.

UltraSight’s AI neural network can predict the position of the ultrasound probe relative to the heart by leveraging the ultrasound video stream and giving guidance about how to manipulate the probe to acquire diagnostic quality cardiac scans.

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UltraSight works with the Philips Lumify Ultrasound System and is an accessory tool for point-of-care ultrasound systems.

"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,” said Davidi Vortman, CEO of UltraSight.  

More than eight million people in the U.S. visit the emergency room for possible heart attacks or heart failure, according to the Centers for Disease Control and Prevention. An estimated 30 million heart disease patients in the U.S. undergo regular cardiac monitoring.

The company said UltraSight has received CE marking in the EU and UKCA marking in the U.K., meaning it has met their regulatory requirements.