TETmedical, Inc., a clinical stage medical diagnostics company developing rapid tools for diagnosing acute neurological injury based on its patented Tethered Enzyme Technology (TET), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its NSE-FAST® (Neuron Specific Enolase — Functional Activity Stroke Test), a rapid in vitro diagnostic assay intended to aid in the diagnosis of acute ischemic stroke.
The designation was issued by the FDA’s Center for Devices and Radiological Health (CDRH), Division of Immunology and Hematology Devices.
