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Medical Devices / Submissions and Approvals

BacterioScan Cleared for UTI Infection Detection System

May 16, 2018
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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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