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.