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# FDA Clears Bright Uro’s Urodynamics Device
- URL: https://www.fdaweb.com/fda-clears-bright-uros-urodynamics-device/
- Published: 2025-04-14T12:00:00.000Z
- Updated: 2026-09-14T14:57:43.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159003

FDA has cleared a Bright Uro 510(k) for its Glean Urodynamics System, a wireless, catheter-free ambulatory urodynamics device designed to support clinical decision-making for patients with lower urinary tract dysfunction. About 80 million Americans suffer from voiding problems, including overactive bladder, urinary incontinence, enlarged prostate and neurogenic bladder, the company says.

The urodynamic analyzer is intended to quantify the pressure and flow characteristics of the lower urinary tract, the company says. It is used in adult patients to perform standard urodynamic tests such as uroflow, cystometrogram, urethral pressure profile, and micturition studies. The device is also designed as an alternative to current catheter-based urethral pressure testing, which is uncomfortable for patients and often generates imprecise data, it adds.