RefleXion Gets FDA Nod for Oncology Platform

Jan. 8, 2026 — RefleXion Medical, an external-beam theranostic oncology company, has announced the U.S. Food and Drug Administration has cleared its next generation, autonomously-guided oncology platform, the RefleXion X2 with SCINTIX therapy, for the treatment of primary and metastatic lung and bone tumors.re

The X2 platform delivers a 20-fold increase in positron emissions tomography (PET) sensitivity, significantly increasing the biological signal for tumor detection. This increased sensitivity aims to expand the number of patients eligible for SCINTIX therapy.

“Clinical outcomes data¹ from our first-generation platform showed that SCINTIX biology-guided radiotherapy enables tumors to autonomously direct their own treatment,” said Sam Mazin, Ph.D., CTO and co-founder of RefleXion. “The goal of the X2 platform is to scale applicability of SCINTIX therapy to a broader patient population, including those with early-stage or metastatic disease.”

The key innovation of the X2 platform is its wide field-of-view PET detector technology, which quadruples the imaging field of view to generate sharper images with less noise and improve visualization of moving tumors. The X2 expands the field of view of the first-generation system from 5 to 20 centimeters, expanding autonomous delivery of SCINTIX therapy to a much larger area.

“We have effectively expanded the 'eyes' of the machine to generate more real time data over a larger portion of the patient’s anatomy, thereby covering the expected range of tumor motion during treatment,” continued Mazin.

Design advancements also allow upgrades across the existing installed base, enabling current RefleXion customers to transition to the full capabilities of the new X2 platform with minimal disruption.

Additional information is available at www.reflexion.com.

1. Tu, Dan et al. Biology-guided radiotherapy for Lung and Bone Tumors: Early insights into Local Control Outcomes from the Prospective PREMIER Registry [NCT05406167]. Presented at ASTRO 2025, San Francisco, CA, USA.