GE HealthCare's StarGuide GX Digital 4D CZT SPECT/CT Receives FDA 510(k) Clearance in the U.S.
GE HealthCare recently announced that its new digital 4D CZT SPECT/CT system, StarGuide GX, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The system had previously obtained CE marking, and this U.S. clearance marks progress in the clinical adoption of its next-generation molecular imaging technology. Designed for theragnostics and precision medicine needs, StarGuide GX is a comprehensive SPECT/CT system. It supports imaging at multiple energy levels, enables general-purpose SPECT imaging, and is tailored for emerging tracer applications, including investigational α-emitters, aiming to provide imaging support for clinicians and researchers exploring new pathways in diagnosis, treatment planning, and therapeutic response monitoring.
2026-09-09
