Bruker Wins FDA Clearance for MALDI Biotyper, Opening up US Clinical Market | GenomeWeb

Having last week received US Food and Drug Administration 510(k) clearance, Bruker's MALDI Biotyper is now approved for clinical microbiology work in the US.

With the clearance, the Biotyper joins its primary competitor, BioMérieux's Vitek MS system, which received 510(k) clearance in August. US hospitals and other facilities that have been waiting on FDA clearance to begin using the system can now implement it as part of their clinical workflows.

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