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- CERTIFICATIONS

Forma Medical Granted FDA Clearance For Optimal Plating System Enabling a Multi-Faceted Growth Strategy for MIS Forefoot Portfolio

CAMP HILL, Pa.–(BUSINESS WIRE)–Forma Medical Inc., a leading innovator in medical device technologies, is thrilled to announce the FDA 510(k) clearance for its groundbreaking OptimalMTP® Plating System. This regulatory milestone marks a significant leap forward in MIS (Minimally Invasive Surgery), ushering in a new era of precision and efficiency dedicated to foot and ankle surgery, one of the fastest growing segments in the medical device space.

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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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