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.
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