FDA Clears Mevion’s CBCT Imaging Solution from medPhoton

Mevion Medical Systems’ strategic partner, medPhoton GmbH, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the ceiling-mounted ImagingRing, an in-room cone-beam computed tomography (CBCT) imaging system. This advanced imaging solution is now available to MEVION S250 Series users in the United States.
 
The new 102cm bore system with ceiling rail mounting, is fully integrated into the Mevion proton therapy system to enable daily soft tissue localization to pair with the HYPERSCAN Pencil Beam Scanning for precision radiation therapy treatments. The ImagingRing CBCT was integrated into the MEVION S250i Proton Therapy System at Maastro Proton Therapy in the Netherlands and has been in clinical use since February 2019.

The Maastro Proton Therapy started treating patients with protons in February 2019. It is the first Mevion system in Europe and because of the compact Mevion technology; it is fully integrated into an existing radiotherapy center, Maastricht Radiation Oncology (Maastro).
 
“We are excited to receive FDA clearance for the ImagingRing,” said Heinz Deutschmann, CEO and founder of medPhoton. “We look forward to expanding the collaboration with Mevion and continuing the development of new capabilities and features to enhance the imaging tools and isocentric workflow for Mevion systems, including ultra large field of view scans, dual energy options and 4D motion management.”
 
Geert Bosmans, managing director of Maastro Proton Therapy, said, “We are using the CBCT system for daily tumor localization, for all our proton patients, in the workflow with the Mevion system. This imaging system is enabling our team to bring precision image guided proton therapy to our patients in the south-west Netherlands region.”
 
While other proton therapy devices provide “one-size-fits-all” imaging systems, Mevion offers an open architecture with a full suite of the latest image-guided proton therapy (IGPT) solutions that allow customers to upgrade their treatment rooms with the latest imaging devices such as medPhoton’s ImagingRing CBCT.
 
“We congratulate medPhoton on the 510(k) clearance of the ImagingRing,” said Tina Yu, CEO of Mevion Medical Systems. “The addition of the ImagingRing has been integral to our commitment to provide proton therapy solutions to our customers.”
 
Mevion Medical Systems Inc. provides compact proton therapy systems for use in radiation treatment for cancer patients. Mevion is based in Littleton, Mass., with a presence in Europe and China.