
FDA Grants Breakthrough Device Designation to TOBY’s AI-Powered Urine Test for Early Bladder Cancer Detection
BOSTON, June 30, 2025 /PRNewswire/ — TOBY, Inc., a biotech startup advancing non-invasive cancer detection through urine-based volatilomics and Artificial Intelligence, announced today the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its TOBY Test for Bladder Cancer.