Submission builds on the X2 platform’s 20X increase in PET sensitivity to further enhance biologic guidance and expand versatility of SCINTIX therapy

RefleXion Medical, an external beam theranostic oncology company, today announced it has submitted 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking clearance for Anchor Point™ Tracking, a next-generation tumor tracking technology designed for use with the new RefleXion® X2 platform.

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Anchor Point Tracking, designed for use with the new RefleXion X2 platform, underpins SCINTIX therapy with higher fidelity biologic data.

“Anchor Point Tracking represents the next major advancement in autonomous radiotherapy,” said Todd Powell, CEO and president of RefleXion. “The X2 platform’s 20-fold increase in PET sensitivity enables development of a sophisticated tracking algorithm that underpins SCINTIX therapy with significantly richer biologic data for directing treatment in real time.

“We believe this additional information will permit more precise and more robust treatment delivery, while creating a scalable platform that expands the range of tumors and clinical scenarios SCINTIX therapy can address.”

The X2 platform’s significantly increased positron emission tomography (PET) sensitivity is produced by quadrupling its onboard PET detectors, providing higher-fidelity biologic data that enables powerful autonomous treatment algorithms such as Anchor Point Tracking. By identifying a consistent biologic “anchor” within the PET data used to track tumors, the X2 delivers an increased level of precision in treatment delivery. If cleared, Anchor Point Tracking is expected to expand the versatility of SCINTIX therapy by supporting treatment across a broader range of tumor sizes, shapes and motion characteristics.

The submission is supported by extensive system validation and phantom testing. Parallel work conducted by leading academic investigators demonstrated improvements in target tracking, dose conformity, motion management and organ-at-risk sparing enabled by the X2 platform and Anchor Point Tracking. These findings will be presented at the 2026 American Association of Physicists in Medicine (AAPM) Annual Meeting, July 19-22, in Vancouver, B.C.

Anchor Point Tracking is currently pending FDA 510(k) review and is not commercially available in the United States.

About RefleXion Medical

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

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“We believe this additional information will permit more precise and more robust treatment delivery, while creating a scalable platform that expands the range of tumors and clinical scenarios SCINTIX therapy can address.”