Bright Uro Receives FDA Clearance For Glean® Abdominal Sensor

New Abdominal Sensor Enables Wireless, Catheter-Free Multi-Channel Urodynamics

IRVINE, Calif., May 7, 2026 /PRNewswire/ -- Bright Uro, a medical device company with a mission to transform care for lower urinary tract dysfunction (LUTD) through innovations in urodynamics, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Glean^® Abdominal Sensor. This new sensor expands the capabilities of the Glean^® Urodynamics System to include multi-channel urodynamic studies. This comprehensive system enables wireless, catheter-free ambulatory urodynamics designed to support clinical decision making for patients with LUTD and other urological conditions.

An estimated 80 million Americans suffer from voiding problems, including overactive bladder, urinary incontinence, enlarged prostate (BPH) and neurogenic bladder^1-4. 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.

The Glean system moves beyond current catheter-based urethral pressure testing, which is uncomfortable for patients⁵ and often generates imprecise data⁶. Glean delivers more accurate data⁷ to enable better-informed treatment plans and is preferred by patients over conventional UDS⁸.

"Glean has been my preferred urodynamics technology since the very first use. The addition of abdominal pressure monitoring and now full multi-channel urodynamics has only expanded its clinical value in my practice," said Dr. Siobhan Hartigan of Hunterdon Health (Flemington, NJ). "Glean delivers reliable data while shortening the learning curve for our clinical staff and capturing real-life physiologic filling data for my patients. While there will always be select cases where conventional urodynamics is warranted, the vast majority of my patients will be excellent Glean candidates going forward."

"Bright Uro continues to deliver on our mission of creating a superior experience for clinicians and patients. The Abdominal Sensor launch is another example of our commitment to innovation and our desire to meet the needs of our customers," said Derek Herrera, CEO and Founder of Bright Uro.

Glean has gained rapid adoption across the US market since launch and has established itself as a technologically superior approach⁷ for performing cystometry and pressure flow studies, now to include abdominal and detrusor pressures.

The introduction of the abdominal sensor less than one year after first commercial launch underscores Bright Uro's commitment to rapid innovation and responsiveness to customer needs. First cases with the abdominal sensor are expected to begin in Q3.

About Glean

The Glean^® Urodynamics System is a urodynamic analyzer system that is intended to quantify the pressure and flow characteristics of the lower urinary tract. Glean is the first and only method to perform wireless, catheter-free urodynamics — delivering more accurate data⁷, quicker proficiency for clinical staff and a more dignified patient experience. The system can be used in adult patients only to perform standard urodynamic tests such as uroflow, cystometrogram, urethral pressure profile, and micturition studies. The major application of urodynamics is the diagnosis of uncontrolled loss of urine (incontinence), abnormal urinary retention, or neurological cases of micturition disorder. The device is intended to be used as medical diagnostic equipment.

Bright Uro has obtained an exclusive licensing agreement from Cleveland Clinic for technology Cleveland Clinic developed in collaboration with the Department of Veterans Affairs, Case Western Reserve University, and Parker Hannifin Corporation. For more information, visit www.GleanUDS.com.

About Bright Uro

Based in Irvine, Calif., Bright Uro's mission is to offer a superior urodynamics experience by building the most advanced diagnostic devices and data science for urodynamics. Founded in 2021 by Derek Herrera — a Marine Raider Special Operations Officer who was paralyzed in combat and went on to become a medical device entrepreneur — Bright Uro is committed to becoming the most trusted and reliable partner for clinicians and patients during their time of need. For more information, visit www.GleanUDS.com.

References:

1. Stewart WF, et al. World J Urol. 2003;20:327–336.
2. NIDDK, NIH. Urologic Diseases in America Annual Data Report. April 26, 2024.
3. Dorsher PT, et al. Adv Urol. 2012;2012:816274.
4. Lee UJ, et al. J Urol. 2021;205(6):1718–1724.
5. Suskind AM, et al, Urology, 2015 Mar;85(3):547-51.
6. Rahmanou, P, et al, Neurourol. Urodyn, 2011, 30:1356–1360.
7. Hamson, et al, J Endourology, online, 2026; 0(0).
8. Kim, J. et al, J Endourology, 2025; 39(6):625-634.

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SOURCE Bright Uro