Israeli digital health company UltraSight has secured CE mark approval for its AI-powered guidance software that enables capturing diagnostic quality ultrasound images of heart.

The UltraSight AI Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients.

The AI technology is intended to help medical professionals capture diagnostic quality ultrasound images of the heart, irrespective of their sonography experience.

UltraSight designed the novel software to pair with currently available point of care ultrasound devices and provide real-time instructions on how to capture high quality diagnostic images.

Its underlying AI neural network can predict the position of the ultrasound probe relative to the heart, and guides the probe to ensure the diagnostic quality images are acquired.

UltraSight CEO Davidi Vortman said: “UltraSight was founded with the intention to apply the power of machine learning in imaging and put the ability to scan patients into the hands of physicians everywhere.

“By empowering more medical professionals to accurately scan patients, we will have faster and greater detection of CVD across the continent.

“This is not only a momentous occasion for UltraSight as a company, but it brings us one step closer to helping the millions of people in Europe who suffer from CVD.”

The CE mark approval is based on results from a clinical study conducted at the Sheba Medical Centre in Israel, using the Philips Lumify ultrasound device.

The study validated the AI-powered technology and confirmed that the software is effective in guiding medical professionals to acquire diagnostic-quality cardiac images.

In addition, the clinical trial found that UltraSight AI guidance allowed medical professionals, who lacked prior sonography experience, to obtain diagnostic quality cardiac images.

UltraSight said that its new AI guidance software serves as an accessory to compatible general-purpose diagnostic ultrasound systems.

It can be used only by medical professionals who received UltraSight’s training.