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BioWorld - Sunday, March 29, 2026
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Home » Sepsis: FDA greenlights Prenosis rapid test, Bosch/Randox aim for another
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Sepsis: FDA greenlights Prenosis rapid test, Bosch/Randox aim for another

April 12, 2024
By Annette Boyle
Prenosis Inc. gained U.S. FDA de novo marketing authorization for an artificial intelligence-powered rapid diagnostic tool for sepsis, one of the most challenging and deadly conditions in hospitals and reported a distribution agreement with Roche Holding AG. Another pairing also made progress in developing a sepsis in vitro diagnostic this week, as Bosch Healthcare Solutions GmbH and Randox Laboratories Inc. joined forces and committed €150 million (US$159.63 million) to the effort.
Medical technology Regulatory Diagnostics Infection U.S. FDA

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