RefleXion Medical has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking clearance for Anchor Point Tracking, a tumor tracking technology designed for use with its RefleXion X2 radiotherapy platform.
Anchor Point Tracking identifies a consistent biological anchor within PET data to track tumors in real time during treatment delivery, according to the vendor. The X2 platform features a fourfold increase in onboard PET detectors compared with its predecessor, producing a 20-fold increase in PET sensitivity that enables the tracking algorithm, RefleXion said. If cleared, the technology is expected to support treatment across a broader range of tumor sizes, shapes, and motion characteristics.
The submission is supported by system validation, phantom testing, and work by academic investigators demonstrating improvements in target tracking, dose conformity, motion management, and organ-at-risk sparing, according to RefleXion. Findings will be presented at the American Association of Physicists in Medicine (AAPM) Annual Meeting, July 19 to 22, in Vancouver, British Columbia, Canada. Anchor Point Tracking is not yet commercially available in the U.S.
