The FDA-approved DaTscan is a Drug Enforcement Administration (DEA) Schedule II controlled substance and is a radiopharmaceutical adjunct imaging agent that works by binding to dopamine transporters (DaT).
The approval was based on two phase 3 clinical trials confirming the efficacy of DaTscan for the visualization of DaT distribution within the striata, an interior part of the brain.
GE Healthcare Medical Diagnostics vice president and general manager Donald Quinn said GE Healthcare personnel are working with hospitals to ensure that these institutions have the proper facilities to handle and use DaTscan and that physicians are trained properly.
"We have a thorough process in place to provide institutions with assistance in DEA-controlled substance registration, imaging equipment set-up, and personnel training for radioactive drug handling and patient imaging protocols," Quinn said.
