The FDA has granted Siemens Medical Solutions 510(k) clearance for the MVision Megavoltage Cone Beam (MVCB) Imaging Package, the latest in the company’s Adaptive Radiation Therapy (ART) portfolio, as well as the AXIOM Wireless Footswitch and AXIOM Voice Control.
MVision is a volumetric in-line target imaging system designed to work with Siemens' linear accelerators. The system is the first commercial implementation of cone beam technology utilizing a standard radiotherapy treatment beam. MVision makes it possible for the megavoltage (MV) source used for treatment also to create a 3D image of the patient.
"Megavoltage cone beam imaging has demonstrated excellent and clinically useful soft tissue contrast needed for many disease sites," said Ajit Singh, PhD, president, Oncology Care Systems, Siemens Medical Solutions. "With MVision, this is achieved without sacrificing dose or time efficiency."
Regarding oncology workflow, MVision is designed to fully integrate and automate all processes, including acquisition, reconstruction, registration, assessment, patient positioning and clinical review. Therapists can calculate 3D offsets simply, send them to the treatment couch to compensate for daily variations, and safely deliver therapy. Another benefit is that MVision does not require an independent imaging source for IGRT.
Both the AXIOM Wireless Footswitch and AXIOM Voice Control -- both wireless footswitch technologies -- were recently FDA cleared. These tools were built to eliminate the hazard of excess cables often found in the examination room. In particular, the Voice Control system allows for hands-free operation to the interventional suite that lets clinicians command the image processing of an AXIOM Artis system directly via voice control signals.