Post by Medical Device Network

Bright 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. Bright Uro’s Glean system, a urodynamic analyser designed to quantify the pressure and flow characteristics of the lower urinary tract, obtained FDA clearance in March 2025. The company’s CEO, Derek Herrera, highlighted that augmenting the system with multi-channel UDS comes in response to customer demand. “The abdominal sensor launch is another example of our commitment to innovation and our desire to meet the needs of our customers,” Herrera said. #urology #UUI #FDA #urodynamics Read the full report below: https://lnkd.in/eNUKHWxt