Bright Uro’s Glean abdominal sensor has obtained US Food and Drug Administration (FDA) clearance, expanding the company’s broader Glean urodynamics system to include multi-channel urodynamic and pressure studies (UDS) in bladder dysfunction evaluation.
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.
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Clearance for the California-based company’s abdominal sensor means that clinicians will be availed with a catheter-free ambulatory urodynamics protocol to support treatment decisioning for patients with lower urinary tract dysfunction (LUTD) and other urological conditions, Bright Uro stated.
Bright Uro’s Glean system, a urodynamic analyser designed to quantify the pressure and flow characteristics of the lower urinary tract, obtained FDA clearance in March 2025. The company’s CEO, Derek Herrera, highlighted that augmenting the system with multi-channel UDS comes in response to customer demand.
“The abdominal sensor launch is another example of our commitment to innovation and our desire to meet the needs of our customers,” Herrera said.
In the US, an estimated 80 million individuals suffer from voiding problems, such as overactive bladder, urinary incontinence, and enlarged prostate (BPH), according to the National Association for Continence.
Neuromodulation’s role in bladder dysfunction treatment
In recent times, Boston Scientific has made moves to advance its urology portfolio with the addition of sacral neuromodulation (SNM) products for treating bladder disorders such as urge urinary incontinence (UUI).
The company drew significant attention at the J.P. Morgan Healthcare conference in January 2026 for its acquisition of urinary incontinence specialist Valencia Technologies. With this deal, for which financial terms were not publicly disclosed, Boston inherited Valencia’s eCoin, a tibial nerve stimulator for UUI.
In October 2024, the medtech giant agreed to acquire Axonics in a $3.3bn deal , availing Boston with SNM products for bladder dysfunction treatment.
Neurological devices are impacting healthcare in a variety of areas beyond bladder dysfunction, including in chronic pain, major depressive disorder (MDD) and Parkinson’s disease. According to a report by GlobalData, the global neurological devices market will reach a valuation of $20.9bn by 2033, up from $12.5bn in 2023.
