Zimmer Garners Warning Letter Over Quality Deficiencies July 20, 2016 The letter revealed numerous serious quality system deficiencies, including CAPA. Read More
FDA Releases Guidance To Back EMC Claims July 20, 2016 The FDA provides a checklist of what manufacturers should include in their submissions. Read More
Study Affirms Safety and Efficacy of Flex Robotic System July 19, 2016 Treatment was successful in 91 percent of transoral procedures. Read More
Roundtable Healthcare Sells Off Beaver-Visitec July 19, 2016 Financial terms were not disclosed. Read More
MHRA Releases Guidance on Remanufacturing Single-Use Devices July 19, 2016 The remanufacturer must ensure that the intended use of the device is the same as the original product. Read More
Guidance Maps Out Codevelopment Pathways for Companion Diagnostics, Drugs July 19, 2016 The guidance describes general principles to guide codevelopment. Read More
Medtronic Gains CE Mark Approval for Guardian Connect July 19, 2016 The system is scheduled to be launched on a “country-by-country basis.” Read More
Theranos Hit With CMS Sanctions; Bans CEO From Lab for Two Years July 18, 2016 The actions follow a litany of quality control failures for the blood testing company. Read More
Syneron’s UltraShape Power Wins FDA Clearance July 18, 2016 The UltraShape Power’s transducer reduces 32 percent of subcutaneous fat thickness. Read More
Essential Medical Secures CE Mark Approval July 18, 2016 Less than a week ago, the company garnered IDE approval. Read More
NGS Guidances Set the Stage for Precision Medicine Initiative July 18, 2016 The agency released two complementary draft guidances. Read More
Terumo Finalizes Acquisition of Sequent Medical July 18, 2016 Terumo initially announced the acquisition back in June. Read More