Bright Uro today announced that the FDA has granted 510(k) clearance for the Glean Urodynamics System, a system that enables wireless, catheter-free ambulatory urodynamics designed to support clinical decision making for patients with lower urinary tract dysfunction (LUTD) and other urological conditions.
The Glean System moves beyond current catheter-based urethral pressure testing, which can be uncomfortable for patients and often generates imprecise data. The company said Glean is easier for clinicians to use, delivers more accurate data to enable better-informed treatment plans, and offers a more comfortable experience for the patient.
The system can be used in adult patients only to perform standard urodynamic tests such as uroflow, cystometrogram, urethral pressure profile, and micturition studies. The major application of urodynamics is the diagnosis of uncontrolled loss of urine (incontinence), abnormal urinary retention, or neurological cases of micturition disorder. The device is intended to be used as medical diagnostic equipment.
Bright Uro was founded by Derek Herrera in 2021 with the goal of developing the most advanced diagnostic sensors and machine learning for Urology. As a Marine Raider Special Operations Officer, Derek was paralyzed from the chest down by a sniper’s bullet in Afghanistan. After recovering, Derek was inspired to develop products to address unmet clinical needs that he personally experienced. He began his career as a medical device entrepreneur in 2015.
“FDA clearance of the Glean Urodynamics System represents a historic milestone for our company,” said Derek Herrera, founder and CEO of Bright Uro. “This achievement is a direct result of the tremendous passion and dedication of our team, and we are excited to tackle our next great challenge – bringing this product to clinicians across the country to help them improve outcomes for millions of patients in need.”
