Intelligent Ultrasound said GE’s SWIFT ultrasound has received FDA sale clearance
(AIM: MED ) said GE Healthcare's Voluson SWIFT ultrasound machine that incorporates GE Healthcare's SonoLyst software with the group’s own ScanNav Assist AI technology, has received 510(k) clearance from the FDA for sale in the USA.
510(k) is a premarket submission showing that a device is as safe, effective and substantially equivalent to a legally marketed device that is not subject to premarket approval.
SonoLyst is the 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 uses two applications leveraging MED’s technology.
These two applications are SonoLystIR and SonoLystX. SonoLystIR performs automated detections of key scanning views and automated selection of relevant Voluson SonoBiometry measurement tools while SonoLystX, a virtual ultrasound expert, compares acquired images to standardised criteria in order to ensure that it meets clinical standards.
SonoLystX can also help to 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 MED’s long-term licence and co-development agreement with GE Healthcare that enables the integration of its 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. Commenting on the clearance, 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."
Shares in Intelligent Ultrasound have jumped over 30% in value since August 2020 and closed at 15.25p on Thursday afternoon trading.
More on Intelligent Ultrasound
MED develops AI-based clinical image analysis software tools for the diagnostic medical ultrasound market and hi-fidelity VR simulators for the ultrasound training market.
Intelligent Ultrasound announced last month that it had been working over the past year to commercialise its AI technology with GE in order to launch the Voluson SWIFT device.
The device’s creation follows a recent study found that obstetrics and gynaecology clinicians in the United States have some of the highest burnout rates among physicians, with the leading factor being bureaucratic tasks like paperwork, charting, and patient data capture.
In a COVID-19 pandemic environment, these clinicians face additional pressures to see more patients and perform exams quickly to limit possible patient exposure to the coronavirus.
The GE Voluson SWIFT, when deployed in private healthcare settings, increases the speed of ultrasound procedures whilst ensuring correct quality levels are consistently achieved.
This has the potential to increase revenue for the operator and therefore provide GE Healthcare with a more compelling sales proposition than that of its competitors.
Prof Aris Papageorghiou, Professor of Fetal Medicine, St George's Healthcare NHS Trust, London called the technology a “big advance for ultrasound imaging in women’s health.”
He added, “I have worked in the field of AI in ultrasound for over ten years, yet I am still amazed at the level of accuracy that has been achieved. You can really see how Intelligent Ultrasound's AI technology, incorporated in the SonoLyst software, will improve efficiency, make the learning of ultrasound easier and reduce omissions and errors.”
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