TETmedical has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for NSE-FAST®, a rapid blood-based test intended to help clinicians evaluate patients who may be experiencing an acute ischemic stroke.

University at Buffalo Business and Entrepreneur Partnerships (UB BEP) supported TETmedical through the Center for Advanced Technology in Big Data and Health Sciences (UB CAT) on a clinical evaluation project for NSE-FAST with UB neurosurgery faculty members Rosalind Lai, MD, assistant professor, and Elad Levy, MD, MBA, SUNY Distinguished Professor and the L. Nelson Hopkins Endowed Chair.

The FDA’s Breakthrough Devices Program is designed to help accelerate the development and review of certain medical devices that may provide more effective diagnosis or treatment for life-threatening or irreversibly debilitating conditions.

A Cornell University spinout, TETmedical is developing rapid diagnostic tools for acute neurological injury. The company plans to initiate a multi-center pivotal study of NSE-FAST in the fourth quarter of 2026.

Read the full announcement.