Bright Uro has received US FDA 510(k) clearance for the Glean Abdominal Sensor, expanding its Glean Urodynamics System into multi-channel urodynamic testing.

This is relevant because lower urinary tract dysfunction remains a large but often under-addressed clinical area. The company notes that an estimated 80 million Americans experience voiding problems, including overactive bladder, urinary incontinence, enlarged prostate and neurogenic bladder.

Traditional urodynamics can be uncomfortable because it often depends on catheter-based pressure testing. Therefore, Glean’s wireless and catheter-free approach could make testing more acceptable for patients while still giving clinicians useful bladder pressure and flow data.

The new abdominal sensor adds abdominal pressure monitoring, allowing the system to measure abdominal and detrusor pressures. This expands the platform from basic wireless testing into fuller multi-channel urodynamics, which may support more informed treatment decisions.

The system is intended for adult patients and can be used for standard urodynamic tests such as uroflow, cystometrogram, urethral pressure profile and micturition studies. It is positioned for diagnosis of incontinence, urinary retention and neurological micturition disorders.

The clearance indicates that urodynamics is also moving toward more patient-friendly diagnostics. As clinics look for better patient experience and more real-world bladder data, wireless systems such as Glean may become increasingly important in urology practice.