The U.S. Food and Drug Administration (FDA) has granted 510 (k) clearance for Fresenius Kabi’s Adaptive Nomogram, an ...

Fresenius Kabi Receives FDA 510 (k) Clearance for Adaptive Nomogram, Enhancing Plasma Collection Efficiency with the Aurora ...

announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Adaptive Nomogram - an alternate algorithm that will be available in the Aurora Xi ...

NEW YORK – Roche said Wednesday that its Tina-quant Lipoprotein (a) Gen.2 Molarity assay has received 510(k) clearance from the US Food and Drug Administration. The test, which is intended for ...

--(BUSINESS WIRE)--#FreseniusKabi--Fresenius Kabi, an operating company of Fresenius, specializing in lifesaving medicines and technologies, announced today that the U.S. Food and Drug Administration ...

NEW YORK — Werfen said Monday that it has received US Food and Drug Administration 510(k) clearance for its Aptiva Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) ...

NEW YORK--(BUSINESS WIRE)--Paige, a leader in next-generation AI technology, announced today that its FullFocus™ digital pathology image viewer received FDA 510(k) clearance, for use with the ...

OSANG Healthcare noted on the 14th that its personal and professional COVID-19 and flu combo kit received official FDA approval (510(k)) about 10 months after receiving emergency use authorization ...

A PCCP allows manufacturers to include a detailed plan for future device changes within a 510(k), PMA, or De Novo submission. Once approved by the FDA, the PCCP allows manufacturers to implement ...

510(k) FDA Clearance Received for Two Digital Pathology ... earning the distinction of being the first FDA-approved AI application in pathology. Paige has also developed the first million-slide ...