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Medical Devices / Submissions and Approvals

BacterioScan Cleared for UTI Infection Detection System

May 16, 2018

The FDA granted 510(k) clearance for BacterioScan’s rapid infection detection system, an automated diagnostic system approved for detecting urinary tract infections.

Current UTI testing is a manual culturing process that can require 2 days or more for results. BacterioScan’s system can detect UTIs in a matter of hours with a laser sensor that reduces lab turnaround time.

The device’s faster detection of infection could lead to less over-prescription of antibiotics, which can promote drug resistance, the company said.

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