FDA clearance opens up US market for Intelligent Ultrasound

Artificial intelligence (AI)-based ultrasound software and simulation company Intelligent Ultrasound announced on Friday that GE Healthcare's ‘Voluson SWIFT’ ultrasound machine that incorporates GE’s ‘SonoLyst’ software with Intelligent Ultrasound's ‘ScanNav Assist’ AI technology had received 510(k) clearance from the Food and drug Administration (FDA) for sale in the United States.

The AIM-traded firm described SonoLyst as “the world's first” fully-integrated AI tool that recognises the 20 views recommended by the International Society of Ultrasound in Obstetrics and Gynaecology mid-trimester practice guidelines for fetal imaging, and featured two applications that leveraged its technology - ‘SonoLystIR’ and ‘SonoLystX’.

It said SonoLystIR performs automated detection of the key scanning views and automated selection of the relevant Voluson SonoBiometry measurement tools; and SonoLystX - a “virtual on-board ultrasound expert” - uses AI to compare the acquired image to standardised criteria, to ensure that it meets clinical standards.

SonoLystX could help enhance accuracy and quality, the board claimed, and was ideal for teaching, training and quality assurance to ensure the highest quality image standards and consistency.

It said SonoLyst was the first AI software to be launched under the group's long-term licence and co-development agreement with GE Healthcare, which enables the integration of Intelligent Ultrasound's real-time AI image analysis software into GE’s Voluson women's health ultrasound portfolio.

The first royalty per unit revenues for Intelligent Ultrasound were expected at the start of 2021.

“SonoLyst is an exciting new scanning aid in women's healthcare and FDA clearance for the Voluson SWIFT opens up the important US market,” said chief technology officer Nicholas Sleep.

“We are delighted to be working with GE Healthcare to bring the latest AI innovations to the global ultrasound market.”

At 0859 GMT, shares in Intelligent Ultrasound Group were down 1.57% at 15.01p.