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March 21, 2022

FDA grants 510(k) clearance for bioMérieux’s Vitek MS Prime

The system enables routine microbial identification in minutes, delivering faster identification results.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for bioMérieux’s new MALDI-TOF mass spectrometry identification system, Vitek MS Prime.

The compact, benchtop solution is a next-generation system designed to maximise routine lab workflow efficiency.

It enables routine microbial identification in minutes, delivering faster identification results.

The Vitek MS Prime increases laboratory productivity to provide a greater impact on patient care.

It has been developed with tools that offer increased Antimicrobial Stewardship (AMS) efficiency and effective patient therapy in order to support labs.

Last April, the new mass spectrometry microbial identification system received CE-mark, and it is currently commercially available in countries that recognise this product marking.

bioMérieux Clinical Operations chief operating officer Pierre Boulud said: “We are really pleased to bring this unique system to labs during the Covid-19 pandemic, when their need for optimal workflow and efficiency are greater than ever.

“In just six months, the adoption rate of customers in Europe has been astounding. Extending access to the US means even more labs can benefit from providing critical information more rapidly to clinicians, so more effective antimicrobial therapy is prescribed sooner.

“Our goal is to empower labs to further improve patient management and play a key role in the fight against antimicrobial resistance.”

The new system integrates Vitek 2, for antimicrobial susceptibility testing, as well as Myla middleware for data integration.

The company stated that the Vitek MS Prime’s commercial launch is underway in many European, Asian and Latin American countries, with plans to extend it globally throughout the year.

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