FDA clears Glean Abdominal Sensor, expanding catheter-free urodynamics platform

The FDA has granted 510(k) clearance to the Glean Abdominal Sensor, expanding the Glean Urodynamics System to enable multi-channel urodynamic testing in a wireless, catheter-free ambulatory format, Bright Uro announced in a May 7, 2026, news release.¹

The clearance broadens the system’s capability to capture abdominal and detrusor pressure alongside cystometry and pressure flow measurements without catheter interference. According to the company, the system is intended to improve patient comfort while supporting clinical decision-making for patients with lower urinary tract dysfunction (LUTD) and other urologic conditions.

The introduction of catheter-free systems aims to address barriers to traditional urodynamic assessments, such as patient intolerance to catheterization and its effects on physiologic voiding behavior.

"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 Siobhan Hartigan, MD, FPMRS, FACS, of Hunterdon Health in Flemington, New Jersey, in the news release.¹ "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."

About the Glean Urodynamics System

The Glean Urodynamics System received initial FDA clearance in April 2025. The system is described as a wireless, catheter-free urodynamic analyzer intended to quantify pressure and flow characteristics of the lower urinary tract in adult patients. According to the company, it supports standard urodynamic assessments including uroflowmetry, cystometrogram, urethral pressure profiling, and micturition studies.

The feasibility and safety of the device was assessed in the prospective Modern Urodynamics System Efficacy (MUSE) trial, which enrolled 32 adult patients with LUTD.² The device was successfully inserted in all patients, and all patients were able to void with the sensor indwelling. There were 14 adverse events (AEs) reported in 12 patients, of which 7 events in 7 patients were related to the device. No serious AEs were observed.

Among all patients, 97% reported that device removal was easy or very easy. Likewise, 81% of clinicians indicated that removals were easy or very easy.²

The newly cleared abdominal sensor expands the platform’s ability to capture multi-channel data during urodynamic assessments.

"Bright Uro continues to deliver on our mission of creating a superior experience for clinicians and patients,” said Derek Herrera, CEO and Founder of Bright Uro, in the company’s news release.¹ “The Abdominal Sensor launch is another example of our commitment to innovation and our desire to meet the needs of our customers.”

According to the company, initial clinical use of the abdominal sensor is expected to begin in Q3 of 2026.

REFERENCES

1. Bright Uro receives FDA clearance For Glean® abdominal sensor. News release. Bright Uro. May 7, 2026. Accessed May 7, 2026. https://www.prnewswire.com/news-releases/bright-uro-receives-fda-clearance-for-glean-abdominal-sensor-302765627.html

2. Kim J, Xavier K, Cannon-Smith T, et al. The Feasibility and Safety of the Glean Urodynamics System: The Modern Urodynamics System Efficacy Study. J Endourol. 2025;39(6):625-634. doi:10.1089/end.2025.0270