FDA grants 510(k) clearance to Glean Urodynamics System

The FDA has granted 510(k) clearance to the Glean Urodynamics System for adult patients with lower urinary tract dysfunction (LUTD), Bright Uro announced in a news release.¹

The device enables wireless, catheter-free ambulatory urodynamics monitoring.

According to the company, 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.

“I consider Glean to be the kind of diagnostic technology advance that the urology community has awaited for decades,” said Alan J. Wein, MD, of the University of Miami, Florida, in the news release.¹ “The system produces information that is closer to a real-life situation than that generated in a urodynamics laboratory. New norms may have to be worked out, but ultimately, I think this has great potential for deciphering lower urinary tract symptomatology and thereby improving patient care.”

Bright Uro shared that the Glean System was found to be easier for clinicians to use, delivered more accurate data, and was more comfortable for patients.

In a prior news release,² the company explained, “The Glean system consists of an insertion tool, a Bluetooth-enabled pressure sensor in a flexible silicone tube, a software app for use by clinicians and patients, and a uroflowmeter to sense volume and flow.”

Bright Uro also explained that the catheter-free design of the system may enable clinicians to collect more ambulatory data with greater physiologic accuracy compared with current standard of care options.

“The majority of urologists, including myself, believe that current urodynamics testing is lacking," said Bilal I. Chughtai, MD, of Northwell Health in New York.¹ “With artificial filling and voiding with catheters in place, patients are often unable to replicate symptoms during the test. Urodynamics is uncomfortable for patients, sometimes even traumatic. Glean will enable patients to void naturally, without catheters in place. I believe this advance will yield a better test that mimics actual symptoms.”

The Glean Urodynamics System was developed by investigators from the Cleveland Clinic, in collaboration with teams from the Department of Veterans Affairs, Case Western Reserve University, and Parker Hannifin Corporation. Bright Uro now holds an exclusive licensing agreement for the technology.

“Today, some providers forego urodynamics due to a paucity of equipment and trained nurses to administer the test,” said Melissa R. Kaufman, MD, PhD, FACS, of Vanderbilt University in Nashville, Tennessee.¹ “Given the simple and versatile nature of how Glean is delivered, we’ll be able to accelerate access so more patients can benefit from this important diagnostic information.”

REFERENCES

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

2. Bright Uro Launches with $6 Million in Seed Financing and Grant from National Institutes of Health. News release. June 9, 2022. Accessed April 2, 2025. https://www.businesswire.com/news/home/20220609005264/en/Bright-Uro-Launches-with-%246-Million-in-Seed-Financing-and-Grant-from-National-Institutes-of-Health