CND Life Sciences Is Granted FDA Breakthrough Device Designation for Its Skin Biopsy-Based Syn-One Test®

CND Life Sciences is Granted FDA Breakthrough Device Designation for Its Skin Biopsy-Based Syn-One Test®

SCOTTSDALE, Ariz., Oct. 7, 2025 /PRNewswire/ -- CND Life Sciences, Inc. (CND), a medical technology company pioneering the development of cutaneous neurodiagnostic tests and associated biomarker services, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough…

CND Life Sciences is Granted FDA Breakthrough Device Designation for Its Skin Biopsy-Based Syn-One Test® – Ortho Spine News

SCOTTSDALE, Ariz., Oct. 7, 2025 /PRNewswire/ — CND Life Sciences, Inc. (CND), a medical technology company pioneering the development of cutaneous neurodiagnostic tests and associated biomarker services, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for the company’s Syn-One Test® for aiding the diagnosis of synucleinopathies in patients aged 40 years and older with neurologic c