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.
![A 53-year-old patient (patient number four) with a recurrent pituitary adenoma with extension of a cystic component of disease to the medial temporal lobe apparent on MRI (contoured in blue), and extension of disease to the left sphenoid bone and orbital apex apparent on [68Ga]Ga-DOTA-TATE (contoured in yellow).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/04/pituitary-tumor.QGsEnyB4bU.jpg?auto=format%2Ccompress&fit=crop&h=100&q=70&w=100)
![A 53-year-old patient (patient number four) with a recurrent pituitary adenoma with extension of a cystic component of disease to the medial temporal lobe apparent on MRI (contoured in blue), and extension of disease to the left sphenoid bone and orbital apex apparent on [68Ga]Ga-DOTA-TATE (contoured in yellow).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/04/pituitary-tumor.QGsEnyB4bU.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
