Jan. 8, 2026 — RefleXion Medical said the U.S. Food and Drug Administration has cleared its next-generation, autonomously guided oncology platform, the RefleXion X2 with SCINTIX therapy, for treatment of primary and metastatic lung and bone tumors.
The company says the X2 delivers a 20-fold increase in positron emission tomography (PET) sensitivity, substantially boosting the biological signal used for tumor detection and aiming to expand the number of patients eligible for SCINTIX therapy.
“Clinical outcomes data from our first-generation platform showed that SCINTIX biology-guided radiotherapy enables tumors to autonomously direct their own treatment,” said Sam Mazin, Ph.D., chief technology officer 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 X2’s key innovation is a wide field-of-view PET detector that quadruples the imaging field of view, increasing it from 5 to 20 centimeters. The wider field produces sharper images with less noise and improves visualization of moving tumors, extending the area over which SCINTIX therapy can be delivered autonomously.
“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,” Mazin said.
Design improvements also allow existing RefleXion systems to be upgraded, enabling current customers to transition to the X2’s capabilities with minimal disruption.
Clinical outcomes from the company’s first-generation platform were presented at ASTRO 2025 (PREMIER Registry, NCT05406167). More information is available at www.reflexion.com.
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