Abionic, an emerging medical diagnostics company focused on rapid early detection technologies, received 510(k) clearance for its PSP test from the U.S. Food and Drug Administration (FDA) to accelerate the Time-to-Detection of Sepsis in critical care and emergency settings. Already certified under the EU IVDR as of July 2022, this FDA clearance marks a pivotal moment for Abionic’s expansion into the U.S. market.
Epalinges
2010
11–50