by Mat Dirjish
Bright Uro, a medical device company specializing in lower urinary tract dysfunction (LUTD), has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Glean Abdominal Sensor. The abdominal sensor expands the capabilities of the company’s Glean Urodynamics System to include multi-channel urodynamic studies. The complete system enables wireless, catheter-free ambulatory urodynamics to support clinical decision making for LUTD patients with other urological conditions.
The new Glean Abdominal Sensor expands the capabilities of the Glean Urodynamics System to include multi-channel urodynamic studies.
The company describes urodynamics as the science of testing how well the bladder, sphincters, and urethra hold and release urine to determine the source of leaks or blockages. Its Glean system eschews current catheter-based urethral pressure testing, which is uncomfortable for patients and often generates imprecise data.
The Glean Urodynamics System is a urodynamic analyzer system that quantities the pressure and flow characteristics of the lower urinary tract. As per its maker, it is the first and only method to perform wireless, catheter-free urodynamics. The system targets adult patients only to perform standard urodynamic tests such as uroflow, cystometrogram, urethral pressure profile, and micturition studies.
A major application of urodynamics is the diagnosis of uncontrolled urine loss, a.k.a., incontinence, abnormal urinary retention, or neurological cases of micturition disorder. Reportedly, contrasting traditional instrumentation, the Glean delivers more accurate data to enable better-informed treatment plans.
Summarily, the introduction of the abdominal sensor underscores the company’s commitment to customer needs. First cases with the abdominal sensor are will begin in Q3 2026. For more details, visit Bright Uro’s Glean System overview.
Mat Dirjish Online 