Bright Uro received FDA 510(k) clearance for the Glean abdominal sensor, expanding the Glean urodynamics system to support multichannel urodynamic studies. The sensor enables clinicians to capture both abdominal and detrusor pressures without the need for catheters. The clearance targets use in treatment decision-making for lower urinary tract dysfunction and related urological conditions, potentially reducing procedural complexity compared with catheter-dependent approaches. For device makers and urology care settings, the update reflects the market’s continued shift toward measurement systems that reduce invasiveness while improving pressure signal quality and workflow efficiency.
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