Federal Clearance for Collaborative Solution

GE Healthcare’s Voluson SWIFT ultrasound machine that incorporates GE Healthcare’s SonoLyst software with Intelligent Ultrasound’s ScanNav Assist AI technology, has received 510(k) clearance from the FDA for sale in the USA.

SonoLyst is an integrated artificial intelligence (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 features two applications that leverage Intelligent Ultrasound’s technology: SonoLystIR and SonoLystX.

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 can help enhance accuracy and quality and is ideal for teaching, training and quality assurance to ensure the highest quality image standards and consistency.

SonoLyst is the first AI software to be launched under the Group’s long-term licence and co-development agreement with GE Healthcare that enables the integration of Intelligent Ultrasound’s real-time AI image analysis software into GE Healthcare’s Voluson women’s health ultrasound portfolio. The first royalty per unit revenues for Intelligent Ultrasound are expected at the start of 2021.

Nicholas Sleep, CTO of Intelligent Ultrasound, said: “SonoLyst is an exciting new scanning aid in women’s healthcare and FDA clearance for the Voluson SWIFT opens up the important US market. We are delighted to be working with GE Healthcare to bring the latest AI innovations to the global ultrasound market.”