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# RefleXion Breakthrough for Radiotherapy
- URL: https://www.fdaweb.com/reflexion-breakthrough-for-radiotherapy/
- Published: 2021-12-06T12:00:00.000Z
- Updated: 2026-09-14T17:24:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150705

FDA has granted RefleXion Medical a breakthrough device designation for its biology-guided radiotherapy for use in treating lung tumors. The device uses injected radiotracers to produce active signals, called emissions, from each tumor to guide treatment delivery, according to the company. It uses positron-emission tomography imaging data to enable tumors to continuously signal their location to a linear accelerator to direct radiotherapy to tumors with sub-second latency.  

RefleXion says the long-term plan for the radiotherapy is to expand treatment options for patients with all stages of cancer. “Several recent lung cancer clinical trials combining radiotherapy with drug therapy demonstrate significant improvements in overall and progression-free survival, despite the inability of current technology to reach more than one to three tumors,” it says.