Bright Uro announced today that it received FDA 510(k) clearance for its Glean urodynamic analyzer system.
Glean, a comprehensive system, enables wireless, catheter-free urodynamics. Bright Uro aims to provide clinicians with more accurate data and actionable insights to aid in clinical decision-making. Glean features an insertion tool and a Bluetooth-enabled pressure sensor in a flexible silicone tube. It also has a software app for use by clinicians and patients and a uroflowmeter to sense volume and flow.
Irvine, California-based Bright Uro designed Glean to support patients with lower urinary tract dysfunction (LUTD) and other urological conditions. It moves beyond current catheter-based urethral pressure testing, which the company says is uncomfortable for patients and often produces imprecise data.
Glean, meanwhile, offers ease of use, delivers more accurate data and provides a more comfortable experience, Bright Uro says.
Last fall, after raising an oversubscribed $32 million Series A round, Bright Uro said it anticipated a 2025 launch Glean. The company also planned to use funds for manufacturing capacity expansion and R&D activities to support expanding its future pipeline.
“FDA clearance of the Glean urodynamics system represents a historic milestone for our company,” said Derek Herrera, founder and CEO. “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.”
