FDA OKs Bright Uro’s Glean Urodynamics System

Bright Uro, a company transforming care for lower urinary tract dysfunction (LUTD) through urodynamics innovations, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Glean urodynamics system.

Urodynamics is the science of testing how well the bladder, sphincters, and urethra hold and release urine to determine the source of leaks or blockages. Glean provides wireless, catheter-free urodynamics to support clinical decision making for patients with LUTD and other urological conditions.

The company said the system overcomes current catheter-based urethral pressure testing, which is uncomfortable and often generates imprecise data. According to Bright Uro, Glean is easier for clinicians to use, provides more accurate data to better inform treatment plans, and is a more comfortable experience for the patient.

The system can be used in adult patients only to perform standard urodynamic tests such as uroflow, cystometrogram, urethral pressure profile, and micturition studies.

Bright Uro was founded by Derek Herrera in 2021, with the aim of developing the most advanced diagnostic sensors and machine learning for urology. Herrera was paralyzed from the chest down by a sniper’s bullet in Afghanistan as a Marine Raider Special Operations Officer.

After recovering, Herrea was inspired—he began his medical device entrepreneurial career in 2015.

“I consider Glean to be the kind of diagnostic technology advance that the urology community has awaited for decades,” said Dr. Alan Wein of University of Miami. “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.”

“The majority of urologists, including myself, believe that current urodynamics testing is lacking,” added Dr. Bilal Chughtai of Northwell Health. “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.”