FDA Clears Next-Generation RefleXion Platform That Improves Tumor Detection

Audio By Carbonatix

HAYWARD, Calif.--(BUSINESS WIRE)--Jan 8, 2026--

RefleXion Medical, an external-beam theranostic oncology company, today 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.

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 data 1 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.

The company will leverage its participation in the 44 th annual J.P. Morgan Healthcare Conference to be held Jan. 12-15 in San Francisco to discuss the newly cleared X2 platform and other commercialization milestones with select investors.

About RefleXion Medical

RefleXion is a privately held theranostic oncology company located in Hayward, Calif., commercializing SCINTIX biology-guided radiotherapy, a novel therapy that uses a single radiotracer injection to turn cancer cells into real-time biological beacons to guide external-beam radiotherapy. SCINTIX therapy is FDA-cleared for FDG-guided treatment of lung and bone tumors, including metastases. The RefleXion X2 platform is also cleared for conventional image-guided radiotherapy for solid tumors located anywhere in the body. For more information, visit 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.

View source version on businesswire.com:https://www.businesswire.com/news/home/20260108743946/en/

CONTACT: Media Contact:

[email protected]

+1-650-239-9070

Media Resources

KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: TECHNOLOGY FDA SOFTWARE BIOTECHNOLOGY RADIOLOGY HEALTH GENERAL HEALTH DATA MANAGEMENT ONCOLOGY

SOURCE: RefleXion Medical

Copyright Business Wire 2026.

PUB: 01/08/2026 09:00 AM/DISC: 01/08/2026 09:00 AM

http://www.businesswire.com/news/home/20260108743946/en