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Medical Dev. & Diag. - Approvals
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
WONTECH's Picosecond Laser PICOCARE Granted FDA 510(k) Clearance for Tattoo Removal 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
OBP Medical Announces SURE-SCOPE Regulatory Approval In Australia 6/15/2017
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
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
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
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
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
LimFlow Receives FDA Approval For U.S. Feasibility Study Of Minimally-Invasive Technology Designed To Restore Perfusion In "No Option" Critical Limb Ischemia Patients 4/26/2017
Intuitive Surgical (ISRG) Receives CE Mark For Latest Da Vinci Robotic-Assisted Surgical System 4/26/2017
Samsung GC70 Digital Radiography System Receives FDA 510(k) Clearance 4/26/2017
Rivanna Medical Receives Health Canada Approval For Accuro Spinal Navigation System 4/26/2017
Synaptive Medical Receives CE Mark In Europe And Regulatory Approval In Australia For BrightMatter Plan 4/25/2017
Bioness Receives CE Mark Certification For The L300 Go System 4/25/2017
Addivant Receives Formal Approval From FDA For Use Of Its Nonylphenol-Free Antioxidant WESTON 705 In Infant Food And Breast Milk Plastic Packaging 4/24/2017
Synaptive Medical Receives CE Mark In Europe And Regulatory Approval In Australia For BrightMatter Plan 4/24/2017
Millennium Medical Technologies First in the Nation to Receive Millennium Medical Technologies Clearance For a Reusable Fat Collection and Grafting System 4/24/2017
GenMark Diagnostics (GNMK) Achieves CE Mark For Its ePlex Blood Culture Identification Fungal Pathogen Panel 4/21/2017
Curetis’ Unyvero Intra-Abdominal Infection (IAI) Cartridge Receives CE Marking 4/21/2017
FDA Clears Halyard Health's COOLIEF* for the Management of Osteoarthritis Knee Pain 4/20/2017
Life Spine Grabs FDA Clearance of PLATEAU-C Ti Cervical Spacer System 4/19/2017
Edwards Lifesciences (EW)' Advanced Hemodynamic Monitoring Platform Receives FDA Clearance 4/19/2017
Lifetrack Medical Nabs FDA Nod for Next Generation PACS for Distributed Radiology 4/19/2017
Ethicon (JNJ) Wins FDA Clearance For ECHELON CIRCULAR PowerEd 4/19/2017
Monitored Therapeutics Wins FDA Nod for First Full Home-Use Spirometer With Wireless Connection 4/18/2017
Advanced Cooling Therapy Receives 510(K) Clearance From FDA For Use With New Control Unit 4/14/2017
FDA 510(k) Clearance for Ventec Life Systems’ VOCSN, the First Portable Unified Respiratory System for Patients on a Ven 4/13/2017
Soterix Medical Receives ANVISA Medical Device Approval In Brazil For Neuromodulation Products Including Painx And Depression-LTE Treatment 4/13/2017
FDA 510(k) Clearance for Entellus Medical (ENTL)’s Eustachian Tube Indication 4/13/2017
Additive Orthopaedics Announces FDA Clearance Of Their Locking Lattice Plating System For The Global Extremities Market 4/13/2017
Royal Philips Electronics N.V. (PHG) Receives FDA Clearance To Market Philips Intellisite Pathology Solution For Primary Diagnostic Use In The U.S. 4/13/2017
Sight Sciences Announces Health Canada Approval Of The VISCO 360 Viscosurgical System For Standalone Microinvasive Glaucoma Surgery (MIGS) 4/13/2017
FDA Greenlights Mazor Robotics’ Spinal Deformity Correction Planning Software 4/12/2017
FDA Clears United Orthopedic Corporation’s Polyethylene Knee Insert 4/12/2017
FDA Gets Verax Biomedical Clearance for Verax PGD Test 4/11/2017
Alere (ALR) Achieves FDA Clearance for Alere Reader Platform and Alere BinaxNOW Influenza A & B Card 2 4/11/2017
Stimwave Announces Regulatory Approval From Australian Therapeutic Goods Administration (TGA) For Its Freedom Spinal Cord Stimulation System 4/10/2017
FDA Grants New Clearance For Verax Biomedical PGD Test For Individual WBD Platelet Units 4/10/2017
FDA Finally Allows 23andMe to Sell At-Home DNA Tests for 10 Diseases 4/10/2017
Bausch & Lomb Snags FDA Nod for Stellaris Elite Next-Generation Phacoemulsification Platform 4/6/2017
FDA Green Lights Becton, Dickinson and Company (BDX)'s New Flow Cytometer System With Leucocount Reagent Assay 4/6/2017
Occlutech Obtains European CE Mark For Its Novel PmVSD Occluder 4/5/2017
VivaLnk Announces FDA 510(k) Clearance and General Availability for eSkin Wearable 4/4/2017
REVA Medical Receives CE Mark For Fantom 4/4/2017
Interpace Diagnostics Announces European Patent Approval For Underlying Technology Of Its Thyramir Microrna Classifier 4/3/2017
Singulex Announces CE Mark For Sgx Clarity System 4/3/2017
NICO Corporation Announces CE Mark For BrainPath Non-Disruptive Cranial Access Technology 4/3/2017
ETS Wound Care Gains FDA Clearance For MIRRAGEN Advanced Wound Matrix 4/3/2017
AstraZeneca PLC (AZN) Release: TAGRISSO (osimertinib) Receives U.S. FDA Full Approval 3/31/2017
Cardiovascular Systems Snags FDA Nod for Its Diamondback 360 Coronary Orbital Atherectomy System (OAS) 3/30/2017
RA Medical Systems, Inc. Receives Approval In China For Pharos Dermatology Laser 3/30/2017
Bodycad Grabs FDA 510K Nod for Personalized Unicompartmental Knee System 3/30/2017
Bay Area's Sonoma Pharma (OCLS) Wins FDA Clearance for Loyon Skin Descaler 3/29/2017
NuVasive (NUVA) Wins First-Ever FDA Clearance for Cervical Interbody Implant System Used in More Than Two Levels 3/29/2017
Providence Medical Technology Snags New FDA Clearances for Standalone Use of CAVUX Cervical Cage-L System and ALLY Facet Screws 3/29/2017
iCAD (ICAD) Wins FDA Approval for PowerLook Tomo Detection 3/27/2017
FDA Green Lights Bovie Medical (BVX)'s Cool-Coag Generator and Open Handpiece 3/27/2017
Surgery Without The Knife: Mirabilis Medica Announces European Approval For Non-Invasive Uterine Fibroid Treatment 3/24/2017
ZOLL (ZOLL) Receives Health Canada Approval fFr Two New Models Of AEDS 3/22/2017
CE Mark Granted To Nucleix's Bladder EpiCheck - Announcing Superior Results Over All Other Non-Invasive Tests In A European Multi-Center Study For Bladder Cancer Monitoring 3/22/2017
FDA Green Lights Medtronic (MDT)'s CoreValve Evolut Pro Transcatheter Valve With Advanced Sealing 3/22/2017
BioStable Science & Engineering Wins FDA Nod for Its HAART 300 Aortic Annuloplasty Device 3/22/2017
Surefire Receives Regulatory Approval For Infusion Systems And Guiding Catheters In Mexico 3/20/2017
Masimo (MASI) Announces CE Marking Of Rad-97 Pulse CO-Oximeter And Connectivity Hub With Noninvasive Blood Pressure 3/20/2017
Trovita Health Science Announces FDA Marketing Clearance Of New SAFE-T FEED Nutrition Delivery Device For Tube Feeding 3/20/2017
Toshiba Medical Systems’ New Premium Cardiovascular Ultrasound Wins FDA Approval 3/17/2017
First Ray Receives FDA Clearance for Expanded Stealth Staple Product Line 3/15/2017
Millar Snags FDA OK for Intracompartmental and Airway Pressure Measurements Using the Mikro-Cath Pressure Catheter 3/15/2017
DJO Global (DJO) Grabs FDA Nod for Exprt Revision Hip 3/15/2017
FDA Clears Teleflex Inc. (TFX)'s Spectre Guidewire 3/14/2017
Teleflex Inc. (TFX) Wins FDA Approval of Its Twin-Pass Torque Dual Access Catheter 3/14/2017
Medtronic (MDT) Snags FDA Approval for First of Its Kind Melody Transcatheter Pulmonary Valve 3/14/2017
FDA OKs Medtronic (MDT)'s New Kyphon Xpede Bone Cement 3/14/2017
PQ Bypass Announces CE Mark For DETOUR Percutaneous Bypass Technologies 3/13/2017
Medtronic (MDT) Nabs FDA Nod for Reveal LINQ Insertable Cardiac Monitor With TruRhythm Detection 3/13/2017
PQ Bypass Wins CE Mark for DETOUR Percutaneous Bypass Technologies 3/13/2017
Spineology Inc. Announces Expanded FDA Clearance Of Elite Expandable Interbody Fusion System 3/13/2017
FDA OKs Expanded Approval of Spineology Inc.'s Elite Expandable Interbody Fusion System 3/13/2017
W. L. Gore & Associates Unveils Next Evolution For TIPS Procedures: Lasting Diameter Control 3/9/2017
Osprey Med Nabs FDA Nod for DyeVert 3/9/2017
Exact Imaging Announces Health Canada Approval And License For Its ExactVu Micro-Ultrasound System For Prostate Imaging And Biopsy 3/9/2017
ZOLL (ZOLL) Hospital Wearable Defibrillator Receives Premarket Approval From FDA 3/9/2017
BTG plc (BTG.L) Announces CE Mark Certification For DC Bead LUMI, The First Commercially Available Radiopaque Drug-Eluting Bead In The EU 3/7/2017
Intellijoint Surgical Announces intellijoint HIP Anterior Application FDA Clearance 3/7/2017
Beckman Coulter Diagnostics Receives FDA Clearance for its DxC 700 AU Chemistry Analyzer 3/7/2017
Nephros (NEP) Snags FDA Clearance of EndoPur Endotoxin 10" Filter 3/6/2017
W. L. Gore & Associates Release: GORE TIGRIS Vascular Stent Gains Health Canada Approval For Treatment Of Peripheral Artery Disease 3/6/2017
Tryton Medical Wins FDA Nod for Tryton Side Branch Stent to Treat Significant Coronary Bifurcation Lesions 3/6/2017
Izun Pharma Announces Approval Of Curasite Hydrogel Wound Care Product By FDA 3/6/2017
NxStage Medical, Inc. (NXTM) Announces CE Mark For Its NxGen Hemodialysis System 3/3/2017



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