MVision AI Receives FDA 510(k) Clearance for Guideline-Based Segmentation Radiotherapy Software

Helsinki, 31st of May, 2022 – MVision AI announces that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for guideline-based, AI-powered software for automatic segmentation for radiotherapy.

Precision, consistency, and reliability play an important role in radiotherapy for cancer treatment. Robust, guideline-compliant auto-segmentation brings quality and standardisation to the clinical workflow.

MVision’s guideline-based segmentation software integrates seamlessly with hospital systems to provide consistent and reliable contours of critical structures – and improve the clinical workflow.

MVision AI primarily operates with cloud-based solutions. However, the software is also available on local servers. To guarantee the most secure and optimal user experience, MVision is HIPAA and GDPR compliant.

Mahmudul Hasan, CEO and founder of MVision AI states:

“We are truly excited to bring MVision’s AI-powered guideline-based segmentation (GBS™) solution to the US market. Our GBS™ solution is widely used in the EU and UK hospitals. These clinics have reported significant workflow efficiency gains, improved consistency, and standardization for contouring.”

About MVision AI

MVision AI provides the high quality of contours for your radiation oncology workflow needs. MVision was founded in 2017, providing many hospitals in EU and EMEA countries with innovative software solutions. With the 510(k) clearance, MVision takes another step towards offering the highest quality auto segmentation service globally.

Are you eager to explore GBS™? Request a demo here. 

MVision AI is active on LinkedInTwitterFacebook, and Instagram. Follow us on social media and subscribe to our newsletter to stay up-to-date on the latest MVision AI news.

Welcome you to contact MVision AI:

c/o Terkko Health Hub, Haartmaninkatu 4, 00290 Helsinki, Finland.

Tel: +358 (0) 40 5489 229



For media inquiries:

Tel: +358 40 500 7915


Our Newsletter

Subscribe to get information, latest news and other interesting offers about MVision AI

Related Posts


MVision AI Appoints Antti Pirskanen as New Chief Financial Officer

Helsinki, Finland – June 14, 2024 – MVision AI, a pioneering company in the development of innovative AI solutions for radiation oncology is pleased to announce the appointment of Antti Pirskanen as its new Chief Financial Officer (CFO). Antti will assume his responsibilities immediately, bringing extensive expertise in financial management…

Press Releases


MVision AI Receives MFDS Approval and Market Authorization for South Korea

HELSINKI, Finland – June 14, 2024 MVision AI is pleased to announce that our application for MVision AI Segmentation (Contour+) in South Korea has been accepted by the Ministry of Food and Drug Safety (MFDS) under the “Image Segmentation Application Software” for image analysis algorithms to be used in radiation…

Press Releases


From Awareness to Action: International Men’s Health Week and Cancer Screening

This year, from 10 to 16 June we celebrate the International Men's Health Week. The dates are different each year, so it precedes and includes Father's Day. Multiple activities around the world aim to raise awareness of men’s preventable health problems and early detection (1). The official framework was created…