FDA clears Bright Uro’s abdominal sensor for evaluating bladder dysfunction

The approval of Bright Uro’s Glean abdominal sensor advances the capabilities of its broader Glean urodynamics system that gained FDA approval in March 2025.

right Uro’s Glean abdominal sensor has obtained US Food and Drug Administration (FDA) clearance, expanding the company’s broader Glean urodynamics system to include multi-channel urodynamic and pressure studies (UDS) in bladder dysfunction evaluation.

Urodynamics is the science of testing how well the bladder, sphincters, and urethra hold and release urine to determine the source of leaks or blockages.

Clearance for the California-based company’s abdominal sensor means that clinicians will be availed with a catheter-free ambulatory urodynamics protocol to support treatment decisioning for patients with lower urinary tract dysfunction (LUTD) and other urological conditions, Bright Uro stated.

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