The FDA has granted Breakthrough Device Designation to MeMed BV Flex, an AI-powered capillary blood test designed to distinguish bacterial from viral infections in 15 minutes using host-response biomarkers.
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Researchers at JAX and MIT have developed a microneedle patch that samples immune cells from skin within hours, providing a noninvasive alternative to blood draws and biopsies.
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The system delivers coagulation test results in under 10 minutes, compared to 30-60 minutes for current platforms.
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The CDC has named Cepheid one of four national collaborators to accelerate rapid diagnostic assay development for public health emergencies under a new federal initiative and IDIQ contract.
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The FDA has granted Breakthrough Device Designations to two 15-minute rapid tests for detecting Candida auris and carbapenem-resistant Acinetobacter baumannii, both identified by WHO as critical priority pathogens.
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