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FDA Breakthrough Device Designation for NSE-FAST stroke test provides regulatory advantages and expedited development pathway.
TETmedical has received FDA Breakthrough Device Designation for its NSE-FAST rapid blood test intended to aid in the diagnosis of acute ischemic stroke. The designation was issued by the FDA's Center for Devices and Radiological Health, Division of Immunology and Hematology Devices. NSE-FAST is a rapid, enzyme-based luminescence assay that measures the functional enzymatic activity of Neuron Specific Enolase in a patient's blood plasma, and is intended for use with other available clinical information to aid in the diagnosis of acute ischemic stroke in adult patients. TETmedical plans to initiate a multi-center pivotal study in the fourth quarter of 2026, with patient enrollment expected to complete in the second half of 2027 and a marketing application submission to the FDA by the fourth quarter of 2027. The Breakthrough Device Designation provides prioritized access to FDA experts and enhanced interaction opportunities, but does not guarantee marketing authorization.
FDA Breakthrough Device Designation for NSE-FAST stroke test provides regulatory advantages and expedited development pathway.