RefleXion gets FDA nod for rad therapy

2020 03 12 17 01 2761 Reflexion Astro 2019 400

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.

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