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Bright Uro Receives FDA Clearance For Glean® Abdominal Sensor

Las Vegas, Nevada (UroToday.com) -- Bright Uro, a medical device company with a mission to transform care for lower urinary tract dysfunction (LUTD) through innovations in urodynamics, 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.


The new Glean® Abdominal Sensor expands the capabilities of the Glean® Urodynamics System to include multi-channel urodynamic studies.

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 data.6 Glean delivers more accurate data7 to enable better-informed treatment plans and is preferred by patients over conventional UDS.8

"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.

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.
Source: Bright Uro. (2026). Bright Uro Receives FDA Clearance For Glean® Abdominal Sensor [Press release]. https://www.gleanuds.com/post/bright-uro-receives-fda-clearance-for-glean-abdominal-sensor/.