Reflexion’s Radiotherapy System Gains FDA Clearance

The FDA granted Reflexion 510(k) clearance for its X1 machine, a linear accelerator that improves the localization of tumors in cancer treatment.

The device features high-quality CT-imaging in conjunction with a linear accelerator that reduces “motion artifacts” caused by patient movement that can hinder the targeting accuracy of the radiation dose to a patient’s tumor.

The device was cleared for stereotactic body radiotherapy — which delivers high doses of radiation using several beams of varying intensity at different angles — stereotactic radiosurgery and intensive modulated radiotherapy.