
Nanopath Granted FDA Breakthrough Device Designation for Its Molecular Diagnostic Platform for Urinary Tract Infections
CAMBRIDGE, Mass., Nov. 18, 2025 /PRNewswire/ — Nanopath, a point-of-care diagnostics company enabling high-quality molecular testing in minutes, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the company’s novel assay for the rapid detection of infection in patients with suspected, or at risk of, complicated urinary tract infections (UTIs).








