Trace-Ability has received approval from the U.S. Food and Drug Administration (FDA) for the first use of its Tracer-QC device at Massachusetts General Hospital (MGH).
The agency is allowing MGH to use Tracer-QC for release testing of nitrogen-13 (N-13) ammonia for injection in PET imaging, according to Trace-Ability. Tracer-QC is designed to automate the PET tracer release testing process.
Tracer-QC was installed and validated at MGH for two release tests for N-13 ammonia, which is used in cardiac PET imaging. Results were submitted to the FDA, which led to the agency's decision to allow MGH to use Tracer-QC in release testing.
