Skip to site menu Skip to page content

Daily Newsletter

29 January 2025

Daily Newsletter

29 January 2025

FDA grants 510(k) clearance to GE HealthCare’s updated ultrasound systems

The systems are equipped with AI-driven features alongside automation tools.

gullapalli January 29 2025

The US Food and Drug Administration (FDA) has granted 510(k) clearance to GE HealthCare’s enhanced Voluson Expert Series ultrasound systems, which include the Voluson Expert 22, 20, and 18 models.

These systems are designed to improve imaging performance and efficiency in women's healthcare by integrating ‘high-resolution’ image quality with the latest ultrasound technology and an ergonomic design.

Equipped with AI-driven features alongside automation tools, the systems aim to support rapid assessments and early identification, intervention, and diagnosis of complex and high-risk pregnancies.

Lyric Architecture of the systems claims to enhance imaging and processing capabilities, providing detailed images that disclose intricate anatomical details, even in challenging scanning conditions.

The SonoLyst set of AI tools is tailored to streamline examinations by recognising images and automating annotations and measurements, thereby enhancing the ‘accuracy’ and ‘speed’ of exams.

GE HealthCare Advanced Visualization Solutions Women’s Health general manager Gerald Seifriedsberger said: “We are proud to introduce these updates to the Voluson Expert ultrasound systems, which represent our ongoing commitment to advancing technology that addresses women's health needs of today, and the future.”

The latest update includes SonoLystlive for use during 11 to 14-week anatomical exams, ensuring that essential views are captured for diagnostic precision.

Moreover, the ultrasound systems feature Graphicflow, an expanded colour Doppler offering that graphically represents blood cell trajectories in real-time.

Enhancements to select Voluson AI tools have also been introduced, including SonoPelvicFloor3.0, which can minimise the time required for pelvic floor measurement exams by 80%.

Additionally, SonoAVCfollicle2.0 leverages AI to enhance the ‘accuracy’ and ‘precision’ in identifying follicles.

The systems are compatible with a variety of speciality probes such as the new lightweight 2D/3D RAB7-D probe and the wireless Vscan Air dual probes.

This development follows a significant £200m ($246.6m) agreement between the company and Nuffield Health to strengthen diagnostic imaging services across Nuffield Health’s hospitals in the UK.

Uncover your next opportunity with expert reports

Steer your business strategy with key data and insights from our latest market research reports and company profiles. Not ready to buy? Start small by downloading a sample report first.

Newsletters by sectors

close

Sign up to the newsletter: In Brief

Your corporate email address *
First name *
Last name *
Company name *
Job title *
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Thank you for subscribing

View all newsletters from across the GlobalData Media network.

close