Howard Goldman, MD, discusses development of the Glean Urodynamics System

The Glean Urodynamics System received FDA 510(k) clearance in March 2025 for adult patients with lower urinary tract dysfunction (LUTD).¹

According to Bright Uro, the system is a “urodynamic analyzer system that is intended to quantify the pressure and flow characteristics of the lower urinary tract.” The device enables wireless, catheter-free ambulatory urodynamics monitoring that can aid decision-making for LUTD.

According to Howard B. Goldman, MD, the idea for the device came from an understanding of the limitations of traditional urodynamics. Specifically, traditional urodynamics is restricted in that it does not mimic normal bladder filling and only offers a single snapshot in time.

Goldman is a professor of urology, the vice chairman of the department of urology, and the fellowship director in urogynecology and urogenital reconstruction at the Cleveland Clinic in Cleveland, Ohio.

Goldman likened the device’s improvement on traditional urodynamics to the difference between an EKG and a Holter monitor. Whereas traditional urodynamics is intended to capture a snapshot of urine function–much like an EKG–the Glean Urodynamics System can be worn for an extended period of time to capture a more holistic picture of urinary function—more akin to a Holter Monitor.

The device was developed by a team at the Cleveland Clinic before being licensed to Bright Uro, who took the device through development to FDA clearance. Urologists at the Cleveland Clinic recently became the first to use the device in clinical practice.²

REFERENCES

1. Bright Uro receives FDA clearance for Glean Urodynamics System. News release. Bright Uro. April 2, 2025. Accessed June 16, 2025. https://www.businesswire.com/news/home/20250402777960/en/Bright-Uro-Receives-FDA-Clearance-for-Glean-Urodynamics-System

2. Cleveland Clinic is first to use wireless, catheter-free device to monitor bladder dysfunction in patients. News release. Cleveland Clinic. June 10, 2025. Accessed June 16, 2025. https://newsroom.clevelandclinic.org/2025/06/10/cleveland-clinic-is-first-to-use-wireless-catheter-free-device-to-monitor-bladder-dysfunction-in-patients