Radiation therapy equipment developer RefleXion Medical has received U.S. Food and Drug Administration (FDA) clearance to market its flagship RefleXion X1 system for conventional radiation therapy treatments.
X1 uses a novel design that combines a linear accelerator with a PET/CT scanner in an oversized gantry. The company is developing the system for what it calls biology-guided radiation therapy (BgRT), in which the linear accelerator directs treatment photons to sites of cancer detected with the PET/CT component.
RefleXion can also perform conventional radiation therapy, and the FDA clearance applies to that clinical use of the system. The company sees the agency's action as a stepping stone to eventual FDA approval for BgRT treatments, according to a statement by the firm.
RefleXion plans to begin commercial shipments of X1 within the next quarter from a manufacturing facility the company opened in 2019.
