Bright Uro Receives FDA Clearance for Glean™ Urodynamics System
Innovative patient-developed technology improves comfort, data accuracy, ease of use
IRVINE, Calif.–(BUSINESS WIRE)–Bright Uro, a medical device company with a mission to transform care for lower urinary tract dysfunction (LUTD) through innovations in urodynamics, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Glean™ Urodynamics System, a comprehensive system that enables wireless, catheter-free ambulatory urodynamics designed to support clinical decision making for patients with LUTD and other urological conditions.
