Mobius Medical Receives FDA 510(k) Clearance for Mobius3D Software

Mobius Medical Systems, LP, the leader in innovative software for quality assurance (QA) in radiation oncology, is pleased to announce that its Mobius3D software has received U.S. market clearance as a Class II medical device from the Food and Drug Administration (FDA).

Mobius3D software is used for QA and treatment plan verification in radiation therapy. It calculates 3D radiation dose directly on a patient’s CT scan or a phantom. The calculation is based on treatment plans initially calculated by a planning system. The MobiusFX module allows users to perform calculations based on linac delivery log data.

Company founder, Nathan Childress, Ph.D., stated, “Mobius Medical was founded in order to provide innovative solutions to the medical physics community. Mobius3D is the result of several years of development and testing. We are very pleased with the FDA clearance and look forward to showing clinicians in the U.S. the vast improvements Mobius3D provides in the safety and effectiveness of patient treatments.”

Mobius3D is the first software to verify patient plans in 3D using an independently developed TPS quality algorithm. Mobius3D works with all major linear accelerators, offering a streamlined workflow. Mobius3D makes patient plan QA faster and easier while supplying details not available from basic MU verification software.

The FDA clearance includes MobiusFX, an optional add-on that utilizes the same independently developed collapsed-cone algorithm with delivery log files to determine 3D dose delivered to the patient. MobiusFX provides clinicians a new and better way to perform patient-specific QA. Current methods that rely on ion chamber or diode arrays, EPIDs, or film are excessively time consuming, taking anywhere from 30 to 90 minutes per patient to complete and analyze. The long time required often necessitates the need for clinicians to work after hours or weekends in order to accomplish this important QA task. MobiusFX only requires enough time to deliver the beams. This allows QA to be easily achieved during breaks between patients or over a lunch hour, offering an opportunity to reclaim those nights and weekends.

As a true 3D solution for patient plan and delivery QA, Mobius3D and MobiusFX can provide information that is not available from traditional methods. Customizable DVH objectives, that include RTOG protocols and Task Group 101 recommendations by default, can be used by Mobius3D to tell clinicians if their treatments are meeting goals. MobiusFX compares data from the machine delivery to expected positions from the TPS plan. This provides users confidence that all parameters were delivered exactly as prescribed. Moreover, MobiusFX will extend the IMRT QA process from a pre-treatment check into per-fraction verifications. Lastly, Mobius3D’s intuitive browser-based interface can be accessed with any computer, tablet, or smartphone, making it extremely easy to evaluate results.