FDA Clears Bright Uro’s Glean Abdominal Sensor for Multi-Channel Urodynamics
Bright Uro has received FDA 510(k) clearance for its Glean Abdominal Sensor. The clearance expands the Glean Urodynamics System into multi-channel urodynamic studies while preserving its wireless, catheter-free design.
The new sensor adds abdominal pressure monitoring to the Glean platform. That allows clinicians to capture abdominal and detrusor pressure data during ambulatory urodynamic testing for patients with lower urinary tract dysfunction and other urological conditions.
Urodynamics is used to assess how the bladder, sphincters and urethra store and release urine. The tests help identify the causes of leakage, retention, blockage and neurological voiding disorders, including conditions linked to overactive bladder, urinary incontinence, benign prostatic hyperplasia and neurogenic bladder.
Bright Uro says Glean moves beyond conventional catheter-based urethral pressure testing, which can be uncomfortable for patients and may produce less precise data. The company says the system is intended for adult patients and can support standard tests including uroflow, cystometrogram, urethral pressure profile and micturition studies.
First cases using the abdominal sensor are expected to begin in the third quarter, less than a year after Glean’s initial commercial launch. The clearance gives urology clinics a broader wireless diagnostic option and could shift more routine urodynamic evaluation away from catheter-based testing.