FDA Approves Roche (RHHBY)'s Blood Test to Diagnose Diabetes
5/24/2013
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Sensus Healthcare Receives FDA Clearance to Treat Keloids With the SRT-100™
5/24/2013
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Medtronic, Inc. (MDT)'s Receives CE Mark for Its CoreValve® System
5/23/2013
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Trulign Lens by Bausch & Lomb Gets FDA Approval
5/22/2013
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Varian Medical Systems (VAR) Receives FDA 510(k) Clearance of Its Nexus DRF Digital X-Ray Imaging System
5/22/2013
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Abbott Vascular (ABT) Receives CE Mark for World's Longest Coronary Drug Eluting Stent
5/21/2013
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Sequent Medical Inc. Launches New SL Family of WEB Aneurysm Embolization Devices
5/21/2013
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FDA OKs EndoChoice's Device Used in Colonoscopies
5/21/2013
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FDA OKs Hologic, Inc. (HOLX)'s C-View 2D Imaging Software
5/21/2013
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Covidien plc (COV) Nellcor Pulse Oximetry Portfolio Gets 510(k) Clearance for Motion Claim
5/20/2013
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Biosensors International Receives CE Mark Approval for BioMatrix NeoFlex™
5/20/2013
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AB SCIEX Announces In Vitro Diagnostic Devices CE Marked for Europe
5/20/2013
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Medtronic, Inc. (MDT) Receives CE Mark for Export Advance Aspiration Catheter
5/20/2013
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Thoratec Corporation (THOR) Announces FDA Approval of HeartMate II® Pocket Controller™
5/17/2013
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NewTom BIOLASE Technology, Inc. (BIOL) VG3 Panoramic Oral X-Ray System Receives FDA Clearance
5/16/2013
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Tryton Medical, Inc. Announces CE Mark and European Launch of Next-Generation Tryton Side Branch SHORT Stent
5/16/2013
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St. Jude Medical (STJ) Receives CE Mark Approval of Its ILUMIEN™ OPTIS™
5/16/2013
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Elixir Medical's DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System CE Marked
5/15/2013
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Devon Medical Products Receives CE Mark for extriCARE®
5/15/2013
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FDA Wins New Genentech (RHHBY) OK for Lung Cancer Drug, Diagnostic Test
5/15/2013
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FDA Clears RaySearch Laboratories' RayStation® 3.5
5/15/2013
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MiE's PET SCINTRON Receives FDA Approval
5/15/2013
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Imaging Diagnostic Systems (IMDS) Announces Ministry of Health Approval in Kuwait to Distribute CTLM®, the innovative 3D Laser Breast Imaging System
5/14/2013
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DiFUSION Technologies Release: VESTAKEEP® PEEK-Based Spinal Implant Receives FDA 510(k) Approval
5/14/2013
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Boston Scientific Corporation (BSX) Receives CE Mark Approval for the Rhythmia™ Mapping System
5/10/2013
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Sorin Group S.p.A. (SRN) Announces FDA Approval and U.S. Launch OF SMARTVIEW™ Remote Monitoring Solution for Patients With Implanted Cardiac Defibrillators
5/10/2013
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FDA OKs NEC Display Solutions's MD211C2 and MD211C3 Medical Diagnostic Monitors
5/10/2013
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Signostics Gets FDA Clearance for Signos RT
5/10/2013
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Houston Medical Device Company Arcos Gets FDA Clearance
5/9/2013
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Abbott Diagnostics Gets a CE Mark for Diabetes Screening Tech
5/9/2013
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FDA Clears BIOLASE Technology, Inc. (BIOL)'s WaterLase® iPlus® All-Tissue Laser
5/8/2013
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St. Jude Medical (STJ) Receives CE Mark Approval for Its Ellipse™ and SJM Assura™
5/8/2013
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First of Its Kind, Combat Medical Systems's Ready Clamp Gets FDA Approval
5/7/2013
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FDA Clears Hill-Rom, Inc.'s MetaNeb 4.0 System
5/7/2013
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Congenix Gains CE Mark for ReLASV® Antigen Rapid Test
5/7/2013
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Corgenix Medical Corporation (CONX) Gains CE Mark for ReLASV® Antigen Rapid Test for Diagnosis of Lassa Fever
5/7/2013
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FDA Approves BIOTRONIK’s Ilesto 7 ICD/CRT-D Series
5/7/2013
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Life Spine Announces FDA Clearance of IRIS™ Anterior Cervical Plate (ACP) System
5/7/2013
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X-spine Announces FDA Clearance of New Spinal Implant System
5/7/2013
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Medtronic, Inc. (MDT) Wins Approval for Device to Resynchronize Heart
5/6/2013
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FDA Approves Johnson & Johnson (JNJ) Sedation Device
5/6/2013
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Masimo Corporation (MASI) RAS-125c Cleared by FDA
5/6/2013
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Fully Automated Diagnostic Device Receives CE Certification; IDx Inc. Planning For Rollout Across Europe
5/6/2013
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FDA Gives 510k Clearance to EyeKor's EXCELSIOR™
5/3/2013
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NeuroSigma, Inc. Receives Health Canada Approval for Its Monarch eTNS System
5/2/2013
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Eventus Diagnostics Receives CE Mark for Octava Pink™ Test
5/2/2013
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BiO2 Medical, Inc.'s IDE Application for the Angel™ Catheter Receives FDA Approval
5/1/2013
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FDA Clears the Expansion of VivaSight™-DL line of Innovative Airway Devices
4/30/2013
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FDA Clears Mauna Kea Technologies, Inc. (Formerly known as Cellvizio Inc.)'s AQ-Flex™ 19 Miniprobe
4/30/2013
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St. Jude Medical (STJ) Announces CE Mark and Launch of First Quadripolar CRT Pacemaker
4/30/2013
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Dayton Medical Device Firm, NovoSource Wins FDA Clearance
4/30/2013
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InterValve Inc. Receives 510(k) Clearance for the V8 Aortic Valvuloplasty Balloon Catheter
4/30/2013
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NxStage Medical, Inc. (NXTM) Announces FDA Clearance for NxStage System One
4/30/2013
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Blockade Medical Announces 510(k) Clearance of the Barricade Coil System
4/29/2013
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Spine Wave, Inc. Gets FDA 510K Clearance for the StaXx® IB System
4/29/2013
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Teleflex Incorporated (TFX) Receives FDA 510(k) Clearance for Next Generation Vascular Positioning System®
4/29/2013
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Olympus Medical Systems Corp. Wins FDA Clearance for HD 3D Surgical System
4/26/2013
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NinePoint Medical Receives Additional FDA 510(k) Clearance for NvisionVLE Imaging System
4/26/2013
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ResMed Inc. (RMD) Noninvasive Ventilation Device Cleared by FDA for COPD
4/25/2013
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Life Care Medical Devices Ltd Announces CE Mark
4/25/2013
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Becton, Dickinson and Company (BDX) Unit Receives FDA Approval for Second Simplist Drug
4/24/2013
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Z-Medica, LLC Announces Expanded CE Indications for QuikClot Hemostatic Dressings Supporting Broader Use in Surgical Wound Care
4/24/2013
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Andrew Technologies, Inc. Receives FDA 510(k) Clearance for Autologous Fat Transfer With HydraSolve™ Lipoplasty System
4/24/2013
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Theradiag Obtains CE Mark for Proprietary Anti-CCP IVD Kit
4/23/2013
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TriReme Medical Inc. Receives Shonin Approval to Market Glider™ PTCA Catheter
4/22/2013
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MedShape Inc. Gets FDA Clearance for Eclipse Soft Tissue Anchor
4/19/2013
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Aspect Imaging Announces FDA Clearance of M2™ Compact MRI System for Clinical Imaging of the Wrist
4/19/2013
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FDA OKs Abbott Medical Optics' TECNIS® Toric Intraocular Lens
4/18/2013
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FDA Clears Microline Surgical (Formerly known as Microline PENTAX) Flexible Ligating Shears for Advanced Tissue Sealing
4/18/2013
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Crescendo Bioscience Announces Laboratory Clearance for Use of Vectra® DA in New York
4/18/2013
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Astro-Med, Inc. (ALOT) Awarded PMA Approval for Cockpit Printer by the FAA
4/18/2013
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Endologix Inc. Announces FDA Approval of First Percutaneous Indication for Endovascular Abdominal Aortic Aneurysm Repair
4/17/2013
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VentriPoint Diagnostics Receives CE Mark for Its NRV™ Application
4/17/2013
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Furui Subsidiary Receives U.S. Approval for Liver Test
4/17/2013
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Injex Pharma Given China Approval for Needle-Free Delivery Device
4/17/2013
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FDA Approves Medical Designs, LLC's SAMBA™ Screw System
4/17/2013
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CAS Medical Systems, Inc. (CASM) Announces FDA Approval of Next Generation FORE-SIGHT® Absolute Tissue Oximeter
4/17/2013
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Aerocrine's NIOX MINO® Device for Measuring FeNO Receives Approval by Health Canada
4/16/2013
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FDA Approves Echosens's FibroScan® for Non-Invasive Liver Diagnosis
4/16/2013
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Accumetrics, Inc. Obtains CE Mark for Therapeutic Window Claim on the VerifyNow P2Y12 Test
4/16/2013
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Luminex Corporation (LMNX) Receives FDA Clearance for MAGPIX w/ xTAG GPP
4/15/2013
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Carticept Medical Wins 510(k) Clearance for Its Navigator® Delivery System
4/15/2013
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Stryker Corporation (SYK) Recall for ShapeMatch Guides Listed as Class I by FDA
4/12/2013
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BIOLASE Technology, Inc. (BIOL) Receives FDA Clearance for the EPIC 10S Soft Tissue Diode Laser for a Broad Spectrum of Medical Procedures
4/12/2013
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Vital Art and Science (VAS)'s Apple (AAPL) iPhone App for Vision Tests Gains FDA Approval
4/12/2013
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IntelligentMDx Announces CE-Marking of a Test for Detection and Differentiation of Influenza A, Influenza B, and Respiratory Syncytial Virus
4/12/2013
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Teleflex Incorporated (TFX) Receives FDA 510(k) Clearance for the ISO-Gard® Mask
4/12/2013
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Kinetic Concepts, Inc. (KCI)'s Portable Therapy System Approved in Japan
4/12/2013
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Becton Dickinson AG Gets FDA 510(k) Clearance and Commercial Launch of BD UltraSafe PLUS™ Passive Needle Guard
4/11/2013
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Maquet Cardiovascular LLC Receives FDA 510(k) Clearance and CE Mark Approval for AIR-BAND™ Radial Compression Device
4/11/2013
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Sophono Alpha 2 Hearing System Receives FDA Clearance for Use With MRI
4/11/2013
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Elekta Receives FDA 510(k) Clearance for Its Versa HD™ System
4/11/2013
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Avioq Announces CE Mark and European Launch of HTLV-I/II Test
4/11/2013
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FDA Clears the Terumo BCT Trima Accel® Automated Blood Collection System
4/10/2013
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BG Medicine (BGMD) Receives CE Mark for Galectin-3 Test
4/10/2013
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St. Jude Medical (STJ) Wins European OK for Brain Implant to Treat Dystonia
4/10/2013
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Olympus Introduces the World's Only Articulating HD 3D Laparoscopic Surgical Video System
4/10/2013
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Bausch & Lomb Receives FDA Approval for PROLENSA™
4/9/2013
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Allied Healthcare Group Seeks 510(k) for Its Heart Tissue Patch
4/9/2013
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Becton, Dickinson and Company (BDX) Release: New Molecular Assay Provides Healthcare Facilities With a Simple, Efficient Way to Detect Dangerous Superbug
4/9/2013
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Monteris Medical, Inc. 's NeuroBlate System Receives 510(k) Clearance
4/8/2013
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CryoLife, Inc. (CRY) Receives FDA Clearance for Next Generation HeRO Device
4/4/2013
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Aerocrine Passes Regulatory Milestone in Japan
4/4/2013
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SAM Medical Products Gets 510(k) Clearance for New Product to Control Junctional Hemorrhage
4/3/2013
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LensAR, Inc. Laser System Receives FDA Clearance for Arcuate Incisions in Cataract Surgery
4/3/2013
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Hitachi Medical Systems America Announces FDA Clearance of Its SCENARIA™ Advanced 128-Slice CT System
4/3/2013
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Health Canada Approves UCB Canada Inc.'s NEUPRO® Patch for Treatment of Parkinson's Disease
4/2/2013
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Aptus Endosystems Inc. Receives CE Mark for Its Thoracic-Length Heli-FXTM System
4/2/2013
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Nuvolase Inc. Receives CE Mark for PinPointe™ FootLaser™
4/2/2013
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Medtronic, Inc. (MDT) Gets FDA Clearance for Oxygenation System
4/2/2013
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Simbionix Gets FDA Clearance for TEVAR System
3/29/2013
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FDA Cleared Chromagen, Inc. Lenses are a Life-Changing Aid for People Struggling With Dyslexia and Other Reading Problems
3/28/2013
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FDA Greenlights Becton, Dickinson and Company (BDX) Syringes; Wilson Plant to Manufacture Product
3/27/2013
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Life Technologies (LIFE) Announces SFDA Clearance for Its 3500xL Dx Genetic Analyzer
3/27/2013
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Quidel Corporation (QDEL) Receives CE Mark for Its Molecular Diagnostic Test
3/26/2013
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BIOTRONIK Iforia is the World's First DF4 ICD/CRT-D Series Approved for MRI
3/26/2013
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Genalyte Inc. Announces CE Mark for Maverick™ Detection System
3/26/2013
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Advanced Bionics Corporation Receives TGA Approval in Australia
3/26/2013
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Tenex Health Announces New FDA 510(k) Clearance
3/25/2013
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Sorin Group S.p.A. (SRN)'s Cardiac Resynchronization Device Wins Conditional FDA Approval
3/25/2013
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Stereotaxis, Inc. (STXS) Receives Regulatory Approval of Niobe(R) Technology in Japan; Begins Commercialization Efforts
3/25/2013
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FDA Approves GE Healthcare's AdreView™
3/22/2013
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SFDA Approval for Amoy Diagnostics Co. LTD.'s EML4-ALK Test
3/22/2013
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Trivitron Healthcare's Medical Device Gets European Nod for Export
3/21/2013
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iTraumaCare Receives European Union CE Marking for iTClamp™ Hemorrhage Control System
3/21/2013
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HiRes Optima™ Sound Processing From Advanced Bionics Corporation Receives Worldwide Approval
3/21/2013
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iCAD, Inc. (ICAD) Receives FDA Clearance of Cervical Applicator for Xoft Electronic Brachytherapy System
3/21/2013
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MEDICREA Receives FDA Pediatric Clearance for PASS® LP Systems
3/21/2013
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FDA Approves Guerbet (GBT)'s New Gadolinium-Based MRI Agent
3/21/2013
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Quantel Medical Inc. Receives FDA Clearance for New Vitra Multispot Laser System
3/20/2013
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Fenwal Secures New FDA Clearance for Device Designed to Help Increase Plasma Available for Transfusion
3/20/2013
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SOOFT italia S.p.A. Receives CE Mark Certification for Its Lontophoresis Device
3/20/2013
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X-spine Announces FDA Clearance of New Implant System
3/20/2013
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Allergan Inc. (AGN)'s "Gummy Bear" Breast Implants Receive FDA Approval
3/20/2013
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Ethicon Endo-Surgery, Inc. Receives 510(K) Clearance for ENSEAL® G2 Cordless
3/20/2013
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EOS Imaging (Formerly Known as biospace med) Receives FDA Clearance for 3D Imaging Software
3/19/2013
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Lantos Technologies Receives FDA Clearance for Its 3D Ear Scanning System
3/18/2013
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InSpire MD Receives CE Mark Approval for Carotid Embolic Protection Stent
3/18/2013
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Regentis Biomaterials Receives European CE Mark Approval for GelrinC
3/18/2013
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ETView Medical, Ltd. Announces SFDA Clearance of a Pre-Marketing Notification Application for the VivaSight-SL Line of Innovative Airway Devices
3/18/2013
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Quidel Corporation (QDEL) Receives FDA Clearance for Virus Detection Test
3/18/2013
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InSpire MD Receives CE Mark Approval for Carotid Embolic Protection Stent
3/15/2013
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FDA Clears Cardiac Designs' Apple (AAPL) iPhone-Based ECG
3/14/2013
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Nanosphere, Inc. Receives CE Mark for BC-GN Test
3/13/2013
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Quidel Corporation (QDEL) Respiratory Virus Test Approved
3/13/2013
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RTI Biologics Gets 510(k) Clearance From FDA for Porcine Dermis Implant
3/13/2013
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Alphatec Spine Receives FDA 510(K) Market Clearance for Its Alphatec Solus™ Internal Fixation Anterior Lumbar Interbody Fusion Device
3/12/2013
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Bedfont Scientific Announce That the GastroCH4ECK™ is Now Available in the U.S. Following Regulatory Approval From the FDA
3/12/2013
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invendo medical GmbH Receives FDA Clearance Computer-Assisted Single-Use Colonoscopy System
3/11/2013
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Endeavor Power Markets Its FDA Cleared Target System
3/8/2013
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Merit Medical Systems, Inc. (MMSI) Receives CE Marking to Market Its Line of Embosphere® Microspheres
3/8/2013
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FDA Approves Roche (RHHBY)'s HCV Test
3/8/2013
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FDA Clears Vital Images, Inc. (VTAL)'s for Its CT TAVR Planning Application
3/8/2013
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Medtronic, Inc. (MDT) Receives CE Mark for Engager Transcatheter Valve
3/7/2013
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Medtronic, Inc. (MDT) Lands EU Approval for Attain Performa CRT-D Leads
3/7/2013
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New Smartphone App, ONCOassist, Certified by CE as a Medical Device
3/6/2013
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Vital 5 Receives Clearance From FDA for Dual Function Catheter System
3/6/2013
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FDA Approves Johnson & Johnson (JNJ)'s Bluetooth Blood Glucose Monitor
3/5/2013
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Tenaxis Medical®, Inc. Receives FDA Approval for its ArterX® Surgical Sealant
3/5/2013
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FDA Approves Two Dako A/S (Acquired by Agilent Technologies, Inc.) (A) Assays as Companion Diagnostics for Genentech (RHHBY)'s Breast Cancer Medicine
3/5/2013
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Health Canada Gives OrthoAccel Technologies, Inc.'s Approval for OrthoAccel
3/5/2013
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Touch Medical Solutions Gets FDA Nod for Medical Imaging Software Suite
3/4/2013
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OrthoAccel Technologies, Inc. Receives Clearance to Sell AcceleDent in Canada - Delivers First Order This Week
3/4/2013
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VentriPoint Diagnostics Receives FDA Clearance for Pulmonary Arterial Hypertension
3/1/2013
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Philips Electronics UK Ltd. Receives FDA Clearance to Market MicroDose SI Mammography System
3/1/2013
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ArthroCare Corporation (ARTC) Receives FDA Clearance for SpeedLock® HIP Knotless Fixation Implant
3/1/2013
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U.S. ARKRAY's Announces FDA Clearance of the Fully Automated Integrated Urine Analyzer AUTION HYBRID™ AU-4050
2/28/2013
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Medtronic, Inc. (MDT) Reports CE Mark for Engager Transcatheter
2/28/2013
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Surgical Theater, LLC™ Receives FDA Clearance for Surgery Rehearsal Platform™
2/27/2013
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Claret Medical, Inc. Announces CE Mark Approval of Montage 2™
2/27/2013
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Medline Industries, Inc.'s Gemini Sterilization Wrap Receives FDA 510(k) Clearance
2/27/2013
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West Pharmaceutical Services Announces the Commercial Introduction of a Novel Intradermal Adapter for Disposable Syringes
2/27/2013
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SpineGuard Wins Approval to Start Marketing PediGuard
2/27/2013
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ALung Technologies Secures CE Mark to Begin European Commercialization
2/26/2013
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On-X Life Technologies, Inc. Receives FDA Approval for On-X Heart Valve With Anatomic Shaped Sewing Ring
2/26/2013
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FDA Clears Tandem Diabetes Care's Diabetes Management Application
2/26/2013
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Surefire Medical, Inc. Receives CE Mark Approval for Next Generation Infusion System and Specialty Catheters
2/26/2013
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NxStage Medical, Inc. (NXTM)'s Single Needle Technology, OneSite, Gets CE Mark Approval
2/25/2013
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FDA Approves BIOTRONIK's Lumax 740 DX System
2/25/2013
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NxStage Medical, Inc. (NXTM) Announces CE Mark Approval for Nocturnal Home Hemodialysis
2/21/2013
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Korean FDA Clearance for Planmed Verity® Extremity Scanner
2/21/2013
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FDA Approves the Allergan Inc. (AGN) Natrelle 410 Breast Implant
2/21/2013
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NxStage Medical, Inc. (NXTM) Receives CE Mark Approval for Nocturnal Home Hemodialysis
2/19/2013
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Dallen Medical Receives FDA Clearance for New Compressyn™ Staple
2/19/2013
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Sanitas, Inc.'s Wellaho Receives FDA Approval for Its Mobile and Web Platform
2/19/2013
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Dune Medical Devices Ltd. Announces European Union Approval of the MarginProbe&#-0174 System Type 1.2
2/19/2013
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ElectroCore® Receives Australian and Colombian Regulatory Approval for GammaCore® Vagal Nerve Stimulation Therapy
2/19/2013
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FDA Approves Medtronic, Inc. (MDT)'s Advisa DR MRI™ SureScan® Pacing System
2/19/2013
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Dako A/S (Acquired by Agilent Technologies, Inc.) (A) Receives FDA Approval for Fast, Accurate, Nontoxic FISH Assay for Cancer Diagnostics
2/15/2013
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Lombard Medical Technologies Wins U.S. Nod for Aortic Stent
2/15/2013
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FDA Approves Second Sight's Argus II Retinal Prosthesis System
2/15/2013
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BIOTRONIK Ilesto 7 ICD/CRT-D Series With ProMRI® Technology Gains CE Approval
2/15/2013
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Hansen Medical Appoints Will Sutton as Chief Operating Officer Responsible for Engineering and Manufacturing
2/14/2013
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PuriCore Receives FDA 510(k) Clearance for Vashe Skin and Wound Hydrogel
2/14/2013
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FDA Clears Fluke Biomedical 's ESA615 Electrical Safety Analyzer
2/14/2013
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ApiFix Receives CE Mark for Its Innovative Treatment System for Scoliosis
2/14/2013
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Theradiag's New Biotherapy Monitoring Kits Receive CE Mark Approval
2/14/2013
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Freedom Meditech, Inc. Receives FDA 510(k) Clearance for ClearPath DS-120™
2/13/2013
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Applied Spectral Imaging (ASI)'s Microscopy Platform Receives FDA Clearance
2/13/2013
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BoneSupport Announces CE-Mark and Launch of CERAMENT™|G
2/13/2013
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