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COCIR Welcomes Balanced Approach Of The Medical Devices Regulation

COCIR welcomes the endorsements on 15 June of the agreement on the Medical Devices Regulation (MDR) by the Council's Permanent Committee (COREPER) and by the European Parliament’s Environment, Public Health and Food Safety (ENVI) Committee. COCIR and its members view...

Vela Diagnostics Announces Launch of CE-IVD HCV Genotyping Next-Generation Sequencing Assay

Vela Diagnostics announced that the Next-Generation Sequencing (NGS)-based Sentosa® SQ HCV Genotyping Assay is now CE marked for in-vitro diagnostic use. It has been certified to meet the requirements for EC Directive 98/79/EC Annex IV for the high-risk IVD...

GE Healthcare Launches New Molecular Imaging Systems That Can Help Quantitative Care and Research

GE Healthcare showcased new molecular imaging technologies at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2016 that will enable clinicians to deliver personalized, quantitative results to patients.  The Discovery MI system and Discovery NM/CT 670 CZT will...

Terumo Cardiovascular Systems says FDA lifts all remaining shipping restrictions at it’s Ann Arbor F

Terumo Corporation announced that Terumo Cardiovascular Systems received notice from the U.S. FDA that it has successfully completed the second and final phase of its work plan to remediate all products manufactured or distributed from Terumo's Ann Arbor, Michigan...

Philips and Rostock University collaborate to deliver networked cardiac care across Germany

Saudi Aramco has signed a Memorandum of Understanding (MoU) with GE and Cividale SpA of Italy to build the Middle East and North Africa’s first-of-its-kind high-end forging & casting manufacturing facility that will serve the region’s maritime and energy...

Medtronic Announces Results of New Approach to ICD Therapy During Cardiostim 2016

Medtronic plc announced results from several feasibility studies evaluating a new approach to implantable cardioverter defibrillator (ICD) therapy at CARDIOSTIM / EHRA EUROPACE 2016, the World Congress in Electrophysiology and Cardiac Techniques, in Nice, France. The Medtronic EV-ICD System, which...

Terumo Launches Global First Tissue-based Product Designed for the Treatment of Heart Failure

Terumo Corporation President and CEO: Yutaro Shintaku announced that in late May it commenced sales of HeartSheet - a global first cellular and tissue-based product designed for the treatment of heart failure.HeartSheet is designed for treating severe heart failure...

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