![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » BacterioScan Cleared for UTI Infection Detection System
BacterioScan Cleared for UTI Infection Detection System
![ClearanceStamp_Blue.gif](https://www.fdanews.com/ext/resources/test/Device_Images6/ClearanceStamp_Blue.gif?t=1576043968&width=430)
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.
Upcoming Events
-
21Oct