New Device IDs Disease-Causing Germs
The Vitaek MS can screen for yeasts such as Candida and Malassezia and bacteria from the Staphylococcaceae and pneumonia families, the agency said in a news release. People with AIDS and others with weakened immune systems are most prone to infections from these germs.
The device uses a laser to break germs into pattern-forming particles that are unique to each yeast or bacterium, the FDA said. Only a small amount is necessary to identify these germs, which collectively are responsible for skin, bloodstream and respiratory infections.
In clinical testing, the new device correctly identified a germ's scientific group or family more than 93 percent of the time, the agency said.
The Vitek MS is manufactured by bioMerieux Inc of Durham, N.C.
More information
The FDA has more about this approval.
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