MedTech News

FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test

SILVER SPRING, Md., June 27, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus (HCV) test that can be used to bring diagnosis to appropriately certified point-of-care settings for individuals at risk for hepatitis C.

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MCRA Supports CamDiab with FDA Approval for Artificial Pancreas Software

WASHINGTON, June 26, 2024 /PRNewswire/ — MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its role in aiding CamDiab’s artificial pancreas software, CamAPS FX, in achieving U.S. Food and Drug Administration (FDA) clearance.

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