Bright Uro Wins FDA Clearance for Multi-Channel Glean Abdominal Sensor, Expanding Wireless Urodynamics Platform

New updates have been reported about Bright Uro.

Bright Uro has secured U.S. FDA 510(k) clearance for its Glean Abdominal Sensor, a new component that upgrades the Glean Urodynamics System to perform full multi-channel, wireless, catheter-free urodynamic studies. This clearance allows Bright Uro to expand beyond bladder pressure testing to include abdominal and detrusor pressure measurement, positioning the company to address a large U.S. market of patients with overactive bladder, incontinence, BPH, and neurogenic bladder.

By eliminating urethral catheters and enabling ambulatory testing, Glean aims to deliver more accurate physiologic data, faster staff proficiency, and higher patient preference compared with conventional urodynamics, which are often uncomfortable and can yield less reliable readings. Early clinical users report that the expanded system shortens learning curves and supports real-world decision making, reinforcing Bright Uro’s value proposition to hospitals and urology practices.

The abdominal sensor’s clearance and near-term commercial introduction, coming less than a year after Glean’s initial launch, highlight Bright Uro’s rapid product-iteration cycle and responsiveness to clinician feedback. First clinical cases using the abdominal sensor are expected to begin in the third quarter, which should accelerate utilization of the installed Glean base and support broader adoption across U.S. urology and urogynecology centers.

For executives and investors, the multi-channel capability materially enhances Bright Uro’s competitive position as the first and only wireless, catheter-free urodynamics platform capable of standard studies such as uroflow, cystometry, urethral pressure profiles, and pressure-flow tests. The company operates under an exclusive license from Cleveland Clinic for key underlying technologies, creating a defensible IP foundation as it pursues scale in a large, under-served diagnostic segment. As reimbursement and clinical guidelines increasingly emphasize patient experience and data quality, the expanded Glean system may help Bright Uro capture share from legacy catheter-based systems and support future business development and fundraising initiatives.