GEHC submits StarGuide GX digital SPECT/CT for FDA clearance

GE HealthCare (GEHC) has submitted its StarGuide GX digital 4D CZT SPECT/CT system for 510(k) clearance from the U.S. Food and Drug Administration (FDA), following the system's recent CE mark in Europe.

StarGuide GX digital 4D CZT SPECT/CT systemGEHC

StarGuide GX is powered by GEHC's dual-sided cadmium zinc telluride (CZT) detector technology, designed to deliver double volume sensitivity and high-resolution imaging with shorter scan times. The system incorporates Nvidia RTX computing for image reconstruction and features a patented dual-collimator detector capable of collimator exchange in less than three seconds, the company said.

The system is designed to image across a broad spectrum of energy levels, supporting both general-purpose SPECT imaging and investigational radioligand therapy isotopes including alpha-emitting agents such as Actinium-225 and Lead-212. GEHC said the ability to accurately image and quantify alpha emitters is expected to become increasingly important for therapy planning, dosimetry, and treatment response monitoring as the theranostics pipeline expands.