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. 

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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


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