Bright Uro, a medical device company focused on treating lower urinary tract dysfunction (LUTD), today announced that the FDA has granted 510(k) clearance for the Glean Abdominal Sensor.
This new sensor expands the capabilities of the Glean Urodynamics System to include multi-channel urodynamic studies. This comprehensive system enables wireless, catheter-free ambulatory urodynamics designed to support clinical decision making for patients with LUTD and other urological conditions.
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.
The Glean system moves beyond current catheter-based urethral pressure testing, which can be uncomfortable for patients and may generate imprecise data. Glean delivers more accurate data to enable better-informed treatment plans and is preferred by patients over conventional UDS.
The introduction of the abdominal sensor less than one year after first commercial launch underscores Bright Uro's commitment to rapid innovation and responsiveness to customer needs. First cases with the abdominal sensor are expected to begin in Q3.
