FDA clears use of Tracer-QC at Massachusetts Gen
The FDA approved the first use of Trace-Ability’s Tracer-QC at Massachusetts General Hospital for testing of an imaging agent used in positron emission tomography (PET)-N-13 ammonia for injection, according to a release.
Tracer-QC automates the conventional PET tracer release testing process.
"Our goal is to help the industry transition to a more streamlined PET drug production and quality control workflow," says Daniel Yokell, associate director for dadiopharmacy and regulatory affairs at the Gordon Center for Medical Imaging at Massachusetts General Hospital. "In turn we can hopefully expand patient access to these critical diagnostic procedures outside of large academic medical centers."