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Medical Dev. & Diag. - Approvals
Approval of Medical Device Changes Often Based On Low-Quality Research, UCSF and Yale University School Of Medicine Study 8/17/2017
Globus Medical (GMED) Wins FDA 510(k) Clearance for Excelsius GPS 8/17/2017
HeartScience Announces CE Mark And European Launch Of Myovista High Sensitivity ECG Device 8/17/2017
Stryker (SYK)’s Spine Division Wins FDA Clearance for Serrato Pedicle Screw 8/16/2017
Glytec LLC Announces Fourth FDA 510(K) Clearance For Its Market-Leading Diabetes Therapy Management Software 8/16/2017
Glytec Nabs Fourth FDA 510(k) Clearance for Its Market-Leading Diabetes Therapy Management Software 8/16/2017
FDA Grants OTC Clearance For American Bio Medica Corporation (ABMC)’s Rapid TOX CUP II 8/16/2017
Camber Spine Technologies Nabs FDA Clearance and National Launch of SPIRA Open Matrix ALIF 8/15/2017
ImpediMed Release: U.S. FDA 510(k) Clearance Issued For SOZO With L-Dex 8/14/2017
Renovis Surgical Wins FDA OK for 3D-Printed Posterior Lumbar Interbody Fusion Systems 8/11/2017
In2Bones USA Scores FDA OK on Two Key Implant Systems 8/9/2017
Xtant Medical Gets FDA Greenlight for Calix-C Cervical Interbody Line Extension and Expanded Indications 8/9/2017
Optovue, Inc. Wins FDA’s First Clearance for Corneal Epithelial Thickness Mapping 8/9/2017
Stimwave Receives FDA 510(k) Clearance for the First Full-Body MRI Scan Ready Wireless Peripheral Nerve Stimulator (PNS) System 8/9/2017
FDA Approves AUM Cardio’s Revolutionary Diagnostic Heart Device 8/8/2017
Optovue, Inc. First In U.S. To Receive FDA Clearance For Corneal Epithelial Thickness Mapping 8/8/2017
Mauna Kea Technologies Gets U.S. FDA 510(K) Clearance for Use of Cellvizio During Robotic-Assisted Surgery 8/8/2017
GE Healthcare's SIGNA Premier Cleared by the U.S. FDA 8/7/2017
Teva (TEVA) Announces FDA Approval Of QVAR RediHaler (Beclomethasone Dipropionate HFA) Inhalation Aerosol 8/7/2017
Standard Bariatrics Receives FDA Clearance for STANDARD CLAMP 8/4/2017
Avacen Medical Gets CE Mark for Increasing Microcirculation and Treating Widespread Fibromyalgia Pain 8/4/2017
Oncotherm Release: Saudi Arabia Approves Oncothermia, The Latest Technology In Cancer Treatment 8/3/2017
Latest Beckman Coulter (BEC) Clinical Flow Cytometry Product Gains FDA Clearance 8/2/2017
Medtronic (MDT) Bags Approval for Avalus Valve in U.S. and Europe 8/2/2017
FDA OKs Xavant Technology's Stimpod NMS460 Non-Invasive Neuromodulation Device 8/2/2017
Accuray Inc. (ARAY) Receives 510(K) Clearance For iDMS Data Management System Upgrade For The TomoTherapy System 8/1/2017
LivaNova (LIVN) Release: VNS Therapy Receives CE Mark For Expanded MRI Labeling 8/1/2017
Medtronic (MDT) Announces CE Mark And European Launch Of CoreValve Evolut PRO Transcatheter Valve With Advanced Sealing 7/31/2017
Myomo Obtains CE Mark Approval For Myopro 7/31/2017
Bruker Corporation Announces U.S. FDA Clearance Of Expanded 3rd Claim For MALDI Biotyper 7/31/2017
CardioFocus Receives Approval For HeartLight Endoscopic Ablation System From The Japanese Ministry Of Health, Labour And Welfare 7/31/2017
Immunalysis Receives First-Ever FDA OK For SEFRIA Fentanyl Urine Drug Screening Test 7/31/2017
EnteroMedics (ETRM) Receives Approval for Gastric Vest System Clinical Study in Spain 7/31/2017
Haemonetics (HAE) Wins FDA Clearance of New Plasmapheresis System Branded NexSys PCS 7/28/2017
Quantel Medical Snags FDA Approval for Easyret Photocoagulator Laser 7/28/2017
Aspect Imaging Nabbed $150 Million and FDA Clearance of the First Dedicated Neonatal MRI System 7/27/2017
Spectranetics (SPNC) Secures FDA Approval of Stellarex Drug-Coated Balloon 7/27/2017
Quantitative Insights Gains Industry's First FDA Clearance For Machine Learning Driven Cancer Diagnosis 7/26/2017
Providence Medical Technology Announces Regulatory Approval From Australian Therapeutic Goods Administration (TGA) For Its DTRAX Line Of Tissue-Sparing Cervical Fusion Products 7/25/2017
Vertera Spine Announces FDA Clearance Of COALESCE Porous PEEK Lumbar Interbody Fusion Device 7/25/2017
Teleflex Inc. (TFX)'s Arrow Seldinger Arterial Catheterization Device Nabs FDA Market Clearance 7/24/2017
Luminex (LMNX) Grabs FDA Clearance for ARIES C. difficile Assay 7/24/2017
Aspect Imaging Wins FDA Approval for the First Neonatal Magnetic Resonance Imaging Device 7/21/2017
Alcresta Snags FDA 510(K) Clearance for Use Of Relizorb in Kids 7/20/2017
Cardiac Science (CSCX) Release: Canadian Regulatory Authority Approves Powerheart G5 Automatic AED 7/20/2017
Masimo (MASI) Grabs CE Marking of Noninvasive RPVi 7/20/2017
Innovus Pharma’s Partner Luminarie Receives Approval For Zestra For Female Sexual Arousal Disorder As A Medical Device I From Australia’s Therapeutic Goods Administration 7/20/2017
Becton, Dickinson and Company (BDX) Wins FDA 510(k) Clearance for New Immunological Diagnostic System 7/19/2017
CSA Medical Nabs FDA 510K Clearance of truFreeze System, RapidAV Spray Catheter 7/18/2017
T2 Biosystems (TTOO) Receives CE Mark For T2Bacteria Panel Enabling Commercialization In Europe 7/18/2017
Voluntis Receives FDA Clearance And CE Mark To Integrate Toujeo 7/18/2017
Great Basin Scientific Wins FDA 510(k) Clearance for Stool Bacterial Pathogens Panel 7/14/2017
Royal Philips Electronics N.V. (PHG) Snags FDA 510(K) Nod to Market Philips BlueControl, an At-Home Psoriasis Treatment Device 7/13/2017
FDA Clears Tyber Medical's TyFix All-in-One Extremity Joint Fixation Device 7/13/2017
TECHLAB Wins FDA OK to Market TRI-COMBO PARASITE SCREEN to Aid Clinicians in the Diagnosis of Giardiasis, Cryptosporidiosis, and Amebiasis 7/13/2017
Saebo, Inc. Announces FDA Clearance of SaeboVR—World's First Virtual ADL Rehabilitation System 7/12/2017
FDA Clears Oventus' O2Vent W 7/12/2017
FDA Green Lights Medtronic (MDT)'s CoreValve Evolut TAVR In Intermediate Risk Patients 7/11/2017
Stryker (SYK)'s MultiGen 2 Radiofrequency Generator Wins FDA 510(k) Clearance 7/11/2017
Masimo (MASI) Announces CE Marking Of Rainbow Super Sensor 7/10/2017
Cerus (CERS) Receives CE Mark Approval For The Contour Neurovascular System For The Treatment Of Intra-Cranial Aneurysms 7/7/2017
GILUPI Release: Approval For German Medical Device In China 7/7/2017
FDA Green Lights Cardiologs' ECG Analysis Platform 7/6/2017
Korean IVD Startup NGeneBio Receives CE-IVD Mark For Next Generation Sequencing-Based BRCA 1/2 Test Panel And Clinical Analysis Software 7/6/2017
K2M Wins FDA Clearance & CE Mark for NILE Proximal Fixation Spinal System 7/6/2017
Chembio (CEMI.OB)’s DPP Zika System Including The DPP Micro Reader Approved By Brazil’s Health Regulatory Agency 7/5/2017
Edwards Lifesciences (EW)' INSPIRIS RESILIA Valve Wins FDA Approval 7/5/2017
Finnish Biomedical Start-Up Nightingale Health Obtains CE Mark For Blood Analysis Platform 7/5/2017
Horizon Discovery Announces Inclusion Of Its Reference Standards In Successful FDA Approval Of An Oncology Companion Diagnostic Test With Leading Next Generation Sequencing Company 7/5/2017
GenMark Diagnostics (GNMK) Achieves CE Mark For Its Eplex Blood Culture Identification Gram-Positive And Gram-Negative Panels 6/30/2017
FDA Approves Illumina (ILMN)'s Next-Generation Sequencing Cancer Companion Diagnostic Test Kit 6/30/2017
Abbott (ABT) Secures Health Canada License For FreeStyle Libre System For People With Diabetes 6/30/2017
SciBase AB Receives US Approval For Nevisense 6/29/2017
Quidel (QDEL)'s RSV Immunoassay Cleared by the FDA, CLIA Waived 6/29/2017
Hologic (HOLX)'s New Panther Fusion System, Flu And Respiratory Assays Now CE Marked In Europe 6/29/2017
Varian Medical Systems (VAR) Gets FDA 510(k) Clearance for Halcyon Treatment System 6/29/2017
FDA Green Lights LivaNova (LIVN)'s VNS Therapy for Drug-Resistant Epilepsy in Kids 6/29/2017
Here's What The Latest Thermo Fisher Scientific (TMO) Really Means And Why It's So Important 6/28/2017
Medtronic (MDT)'s SureTune3 Earns CE Mark for DBS Therapy 6/28/2017
Royal Philips Electronics N.V. (PHG) Gets FDA Clearance to Market Multiple New Applications on its Intellispace Portal Platform for Radiology 6/27/2017
Mobidiag Announces Release Of Amplidiag Viral GE, A Multiplex PCR Test To Detect Gastrointestinal Viruses Directly From Stool Samples 6/26/2017
Channel Medsystems Earns CE Mark Approval For The Cerene Cryotherapy Device 6/26/2017
WONTECH's Picosecond Laser PICOCARE Granted FDA 510(k) Clearance for Tattoo Removal 6/23/2017
FDA Approves Thermo Fisher Scientific (TMO)'s First Companion Diagnostic Test to Screen Multiple Non-Small Cell Lung Cancer Therapies 6/23/2017
Roche (RHHBY) Scores FDA Nod For Fourth-Generation HIV Combination Antigen-Antibody Assay 6/23/2017
FDA Clears Insulin Algorithms Comprehensive Insulin-Titration Software For Clinicians 6/23/2017
French Health System Approves Reimbursement Of QIAGEN N.V. (QGEN)'s QuantiFERON Latent TB Test 6/22/2017
Exactech (EXAC) Expands Presence In Japan With Newly Approved Shoulder, Knee And Hip Replacement Systems 6/22/2017
Merit Medical (MMSI)’s Embosphere Microspheres Receive FDA 513(F)(2) (De Novo) Classification For Prostatic Artery Embolization Indication 6/22/2017
Data MATRIX Ltd. Release: European Biotech Meets New Company 6/22/2017
Advanced Sterilization Products Nabs FDA Clearance for World's First 30-Minute Biological Indicator for Low Temperature H202 Sterilization 6/21/2017
FDA Green Lights ClearFlow's FlowGlide Technology for Cardiac Surgery Patients 6/21/2017
Sommetrics Receives Health Canada Approval To Market New Sleep Apnea Therapy 6/21/2017
Additive Orthopaedics Announces FDA Clearance of their Minimally-Invasive, Intramedullary 3D Printed Bunion Correction System for the Extremities Market 6/21/2017
Becton, Dickinson and Company (BDX) Nabs FDA Clearance for New Line of Customizable, 3.0mm Micro-Laparoscopic Instruments 6/20/2017
FDA Clears Hologic (HOLX)'s Aptima Assay to Detect Herpes Simplex Virus 1 & 2 6/20/2017
ConforMIS Wins FDA 510(k) Clearance for iTotal Hip System 6/20/2017
MEDICREA Announces FDA Clearance And Initial Experience With PASS TULIP Top-Loading Fixation In World-First Patient-Specific Hybrid Constructs 6/19/2017
FDA Clears Meditech Spine's Next Generation Lumbar Fusion Devices 6/19/2017
Hologic (HOLX) Receives Expanded FDA 510(K) Clearance To Market Cynosure's Sculpsure For Non-Invasive Body Contouring (Lipolysis) Of Back, Inner And Outer Thighs 6/15/2017
Skyline Medical Announces CE Mark For The STREAMWAY System 6/15/2017
MaaT Pharma Announces CE Marking For Its Globally Unique Medical Device 6/15/2017
FDA Clears MAGNETOM Vida 3T MRI System From Siemens Healthineers (SI) 6/15/2017
OBP Medical Announces SURE-SCOPE Regulatory Approval In Australia 6/15/2017
Fluicell Receives Green Light With A New BioPen Patent In The U.S.A. 6/14/2017
Mologic Receives CE Mark Approval For Periplex Diagnostic For Infection In Patients On Peritoneal Dialysis 6/14/2017
Bio-Rad (BIO) Announces FDA Clearance Of Its Bioplex 2200 Syphilis Total & RPR Assay, A Novel Syphilis Testing Method 6/13/2017
SI-BONE Wins FDA Clearance and Full U.S. Commercial Launch of the iFuse-3D Implant 6/13/2017
Milestone Scientific (MS) Snags 510(k) FDA Clearance for Epidural Anesthesia System 6/13/2017
TECHLAB Grabs FDA 510(k) Clearance to Market E. HISTOLYTICA QUIK CHEK 6/13/2017
BIOTRONIK Receives CE Mark For 3 Tesla Full-Body Mris With Newest Pacemakers 6/13/2017
GenMark Diagnostics (GNMK) Bags FDA Clearance for Its ePlex Instrument and Respiratory Pathogen Panel 6/12/2017
Waters Corporation (WAT) UPLC And Mass Spectrometry Systems Approved For In-Vitro Diagnostic Use In Brazil 6/9/2017
Thornhill Medical's Portable Emergency Life Support System Wins 510K Clearance From The FDA 6/8/2017
QIAGEN N.V. (QGEN)'s QuantiFERON-TB Gold Plus Gains FDA Approval 6/8/2017
Medovex Corporation Receives CE Mark Approval For DenerveX System 6/7/2017
FDA Clears W. L. Gore & Associates's GORE SYNECOR Preperitoneal Biomaterial Hernia Repair Device 6/7/2017
FDA OKs Hologic (HOLX)'s Genius 3D Mammography Exam as the Only Mammogram Superior for Women With Dense Breasts 6/7/2017
AngioDynamics (ANGO) Wins FDA Clearance for The Solero Microwave Tissue Ablation System 6/7/2017
Forbes Under 30 Alumni Scores FDA Clearance For New Heart Monitor 6/7/2017
Zebra Announces Regulatory Approval Of Its Deep Learning Imaging Analytics Engine 6/7/2017
Edwards Lifesciences (EW)' SAPIEN 3 Valve Wins FDA Nod for Aortic, Mitral Valve-In-Valve Procedures 6/6/2017
FDA Green Lights QIAGEN N.V. (QGEN)'s CMV Testing on Automated QIAsymphony Platform 6/6/2017
OrbusNeich Announces FDA Clearance, Launch of Coronary Dilatation Catheters 6/6/2017
Ethicon (JNJ) Announces FDA Approval For SURGICEL Powder Absorbable Hemostat 6/6/2017
Boston Scientific (BSX) Receives CE Mark For Vercise Gevia Deep Brain Stimulation System 6/6/2017
Medtronic (MDT) Suretune3 Receives Health Canada License For Deep Brain Stimulation Therapy 6/6/2017
Clarify Medical Core Technology Receives FDA Clearance 6/6/2017
Becton, Dickinson and Company (BDX) Nabs FDA Clearance for Molecular Test for Harmful Intestinal Bacteria Causing Infectious Diarrhea 6/5/2017
Bay Area's Claret Medical Wins FDA Nod to Market Sentinel Cerebral Protection System in the U.S. 6/5/2017
Roche (RHHBY) Snags FDA Nod for CMV Viral Load Testing on Cobas 6800/8800 Systems 6/5/2017
Expanding Orthopedics Inc. Expands The FLXfit Family Of 3D Cages, Launches The FLXfit15 With 15 Degrees Of Lordosis Correction 6/5/2017
GenePOC Nabs FDA Clearance for Revogene Instrument and its GBS LB Test 6/1/2017
Roche (RHHBY) Snags FDA Nod for Companion Diagnostic to Identify ALK-Positive Non-Small Cell Lung Cancer Patients 6/1/2017
Singulex Release: First Ultra-Sensitive Cardiac Troponin (cTnI) Test Using Single Molecule Counting Technology Receives CE Mark 6/1/2017
FDA Green Lights Intuitive Surgical (ISRG)'s da Vinci X Surgical System 5/31/2017
Quidel Corporation (QDEL) Receives FDA Clearance And CLIA Waiver For Its Point-Of-Care Sofia 2 Immunoassay Analyzer For Use With Sofia Influenza A+B Assay 5/31/2017
OrthoAccel Tech's New AcceleDent Optima Receives FDA Clearance 5/31/2017
Atonomics Announces CE Marking Of Trace Lipids Test Panel 5/31/2017
CE Mark For Implandata's EYEMATE System For Improved Monitoring And Management Of Glaucoma Patients 5/31/2017
Masimo (MASI) Nabs FDA Clearance of O3 Regional Oximetry for Pediatric Patients 5/30/2017
FDA Grants Market Clearance to RA Medical's New PAD System 5/30/2017
Stimwave Receives CE Mark Approval For World’s First Fully Percutaneous Stimulator Anchoring System 5/30/2017
Vexim: ANVISA Approves SpineJack Implants In Brazil 5/30/2017
Atomo Diagnostics’ HIV Self Test Receives Approval From Kenya Ministry Of Health 5/30/2017
Quidel Corporation (QDEL) Receives PMDA Approval For Its Point-Of-Care Sofia Influenza A+B Assay 5/25/2017
W. L. Gore & Associates Release: GORE EXCLUDER Iliac Branch Endoprosthesis Approved In Japan 5/24/2017
SCIEX Nabs First FDA-Cleared Vitamin D Assay Kit For Mass Spectrometry 5/24/2017
eMed Technologies Partners With Global Pharma Leaders In New FDA 510(K) Clearance 5/23/2017
Cook Medical Wins FDA Approval for Device to Treat Rare Birth Defect 5/22/2017
FDA Clears Soterix Medical's IontoDC System 5/22/2017
Bay Area's MyoScience Wins FDA Nod for Iovera Knee Osteoarthritis Device 5/18/2017
Elixir Medical Announces Outstanding 5-Year Clinical Data For CE Mark-Approved Desolve Novolimus Eluting Bioresorbable Coronary Scaffold System 5/17/2017
CrossBay Medical Announces FDA And CE Mark Marketing Authorizations For Its IVF Embryo Transfer Catheter Set 5/17/2017
Sweden's BrainCool Enters U.S. Market With FDA 510(k) Clearance for IQool System for Temperature Management 5/17/2017
FDA Clears Body Vision's LungVision Navigation System, Revolutionizing Lung Cancer Detection and Treatment 5/16/2017
Shockwave Medical Snags CE Mark for Coronary Lithoplasty System 5/15/2017
Aptar Pharma’s Electronic Lockout Device Approved By FDA 5/15/2017
Exactech (EXAC) Receives 510(k) Clearance For Computer-Assisted Shoulder Arthroplasty Technology 5/15/2017
TearLab (TEAR) Osmolarity System Receives Brazilian Regulatory Approval 5/12/2017
STAAR Surgical (STAA) Announces CE Mark Approval For The EVO+ Visian ICL With Aspheric (EDOF) Optic 5/11/2017
Medtronic (MDT) First to Receive FDA Clearance for MRI-Safe Pacemaker Devices 5/11/2017
NxStage (NXTM) Nabs FDA OK for its New System One Hemodialysis System 5/11/2017
NDS Receives FDA Clearance For ZeroWire Mobile Battery-Powered Display Stand 5/11/2017
Obalon Receives Regulatory Approvals To Commercialize In Select Middle East Markets 5/11/2017
Life Spine Wins FDA 510(k) Clearance of the CRANIAL FUSION System With SOLSTICE Screws for Cervical Spine Indications 5/10/2017
Varian Medical Systems (VAR) ProBeam Proton Therapy System Receives Shonin Approval 5/10/2017
Faster FDA Approvals? Not So Fast: 1 Out of 3 New Drugs Had Safety Problems No One Knew About 5/10/2017
Abbott (ABT) Announces CE Mark for TactiCath Contact Force Ablation Catheter, Sensor Enabled 5/9/2017
Boston Scientific (BSX) Snags FDA Approval for Resonate Family of High-Voltage Devices 5/9/2017
BIOTRONIK Nabs FDA OK of MultiPole Pacing with ProMRI: 360° Solutions for Patients With Heart Failure 5/9/2017
FDA Green Lights BIOTRONIK's Sentus ProMRI Quadripolar Left Ventricular Lead 5/9/2017
ZipLine Medical Receives India Regulatory Approval For Non-Invasive Zip Skin Closure System 5/9/2017
CurveBeam Announces FDA 510(k) Clearance for InReach Cone Beam CT Imaging System for the Upper Extremities 5/9/2017
Bovie Medical (BVX) Receives 510K Clearance For Its J-Plasma Precise Flex Handpiece 5/8/2017
Bovie Medical (BVX) Snags FDA Clearance for Its J-Plasma Precise Flex Handpiece 5/8/2017
Abbott (ABT) Announces CE Mark And First Use Of The World's First Smartphone Compatible Insertable Cardiac Monitor 5/8/2017
Medrobotics Snags FDA Clearance for Flex Robotic System for Scarfree Colorectal Procedures 5/8/2017
FDA Clears MagVenture's New Non-Pharma Depression Device 5/8/2017
LensAR Receives FDA Clearances For Laser Cataract Platform Integration With OCULUS Pentacam Tomographers 5/8/2017
Crospon Nabs FDA Clearance For Endoflip With Flip Topography Module 5/5/2017
Roche (RHHBY) Nets FDA Nod for Complementary PD-L1 (SP263) Biomarker Test in Urothelial Carcinoma 5/3/2017
Luminex (LMNX) Receives FDA Clearance For ARIES Bordetella Assay 5/3/2017
Acutus Medical Snags FDA OK for AcQGuide Steerable Sheath 5/3/2017
InterScope Technologies Wins FDA Clearance for EndoRotor, the First Flexible Shaver Technology for Interventional Gastroenterology 5/3/2017
Teleflex Inc. (TFX) Wins FDA 510(k) Clearance for the Arrow AC3 Optimus Intra-Aortic Balloon Pump 5/2/2017
FDA Clears Faxitron's LOCalizer Radiofrequency ID System for Breast Lesion Localization 5/1/2017
FDA Green Lights Medtronic (MDT)'s Resolute Onyx Drug-Eluting Stent, the First Available in 4.5 mm and 5 mm Sizes 5/1/2017
FDA Clears Roche (RHHBY)'s High-Volume Immunoassay Lab Testing Solution 5/1/2017
CFDA Approves Venus MedTech's Minimally Invasive Aortic Valve Implant 5/1/2017
Coapt Now First And Only Advanced Myoelectric Control System With FDA Class II Clearance 5/1/2017
Venus MedTech's TAVR Device Is Approved By CFDA, Creating A New Era Of Interventional Cardiology In China 4/28/2017
InVivoScribe Technologies, Inc. Receives FDA Approval For The Leukostrat Cdx FLT3 Mutation Assay Companion Diagnostic Test For The Selection Of Patients For Rydapt And Is The First Companion Diagnostic For AML 4/28/2017
Eclipse Aesthetics MicroPen Elite Cleared By Health Canada 4/27/2017
Contego Medical Receives CE Mark For Vanguard IEP Peripheral Balloon Angioplasty System With Integrated Embolic Protection 4/27/2017
Mentor Corporation (MNTR) Nabs FDA Approval for MemoryGel XTRA Silicone Gel-Filled Breast Implants 4/27/2017
FDA Green Lights joimax's New Minimally Invasive Spine Surgery Device 4/27/2017
Reapplix ApS Release: New FDA 510(K) Clearance For Expanded System Including Automated Centrifuge 4/27/2017
FDA Green Lights Allergan (AGN)'s Tear-Inducing Eye Device TrueTear 4/26/2017
Bausch & Lomb Wins FDA Nod for Vitesse, the First and Only Hypersonic, Open-Port Vitrectomy System 4/26/2017



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