Bright Uro expands Glean platform with FDA-cleared abdominal sensor for catheter-free urodynamics

USA—Bright Uro has secured US Food and Drug Administration (FDA) clearance for its Glean abdominal sensor, expanding the capabilities of its Glean urodynamics system for multi-channel urodynamic studies (UDS) in bladder dysfunction evaluation.

The approval enables catheter-free ambulatory testing that captures bladder pressure and flow in real-world conditions.

Urodynamics assesses how the bladder, urethra, and sphincters store and release urine to identify causes of leakage or obstruction.

With this clearance, the California-based company strengthens its diagnostic tools for lower urinary tract dysfunction (LUTD) and other urological conditions.

FDA clearance enhances Glean platform

Bright Uro integrated the newly cleared abdominal sensor into its existing Glean platform, which the US FDA approved in March 2025.

The system measures pressure and flow dynamics in the lower urinary tract to improve diagnostic accuracy in bladder function assessment.

The company said the added multi-channel UDS capability addresses clinician demand for more adaptable and less invasive testing.

Chief Executive Officer Derek Herrera noted that the development reflects customer-driven innovation and a focus on improving clinical workflows while enhancing patient comfort during diagnostic procedures.

Catheter-free testing expands clinical use

The abdominal sensor enables ambulatory urodynamic testing without traditional catheter-based systems, improving patient mobility and comfort during assessment.

This approach provides more realistic physiological data during daily activities, supporting better-informed clinical decisions.

Bright Uro stated that the technology supports evaluation of conditions such as overactive bladder, urinary incontinence, and benign prostatic hyperplasia (BPH).

In the United States, approximately 80 million individuals experience voiding dysfunction, according to the National Association for Continence, highlighting strong demand for improved diagnostic tools.

Competitive activity in urology devices

The urology device sector continues to see rapid innovation as major players expand their portfolios.

Boston Scientific has strengthened its position in bladder disorder treatment through sacral neuromodulation (SNM) technologies targeting conditions such as urge urinary incontinence (UUI).

The company attracted attention at the January 2026 J.P. Morgan Healthcare Conference after acquiring Valencia Technologies, gaining its eCoin tibial nerve stimulation system.

Earlier, in October 2024, Boston Scientific completed its USD 3.3 billion acquisition of Axonics, expanding its neuromodulation capabilities for bladder dysfunction therapies.

Neurological devices market expansion

Neurological devices are increasingly applied beyond urology into areas such as chronic pain, major depressive disorder (MDD), and Parkinson’s disease.

Industry forecasts project sustained growth in this sector over the next decade. Market estimates indicate expansion from USD 12.5 billion in 2023 to USD 20.9 billion by 2033, driven by advances in minimally invasive technologies and demand for precise diagnostic solutions.

Recent company updates from Bright Uro indicate continued efforts to scale adoption of its Glean system across clinical sites in the United States, supporting broader integration of sensor-based urodynamic testing in routine care.