MassDevice

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.

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