Elevate Weekly

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.

The system overcomes current catheter-based urethral pressure testing, which is uncomfortable and often generates imprecise data. Bright Uro, a company transforming care for lower urinary tract dysfunction (LUTD) through urodynamics innovations, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Glean urodynamics system. Urodynamics is the science of testing how well the bladder, sphincters, and urethra hold and release urine to determine the source of leaks...

Glean, a comprehensive system, enables wireless, catheter-free urodynamics. Bright Uro aims to provide clinicians with more accurate data and actionable insights to aid in clinical decision-making. Glean features an insertion tool and a Bluetooth-enabled pressure sensor in a flexible silicone tube. It also has a software app for use by clinicians and patients and a uroflowmeter to sense volume and flow.