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Medical Dev. & Diag. - Regulatory
Teijin Pharma Release: Supplemental Application Filed For Somatuline In Japan For Additional Indication Of Neuroendocrine Tumors 7/27/2016
Sight Sciences Receives Full Investigational Device Exemption (IDE) Approval From The US FDA To Initiate The VISCO360 Versus SLT Glaucoma Trial 7/27/2016
NovoCure Release: National Comprehensive Cancer Network Guidelines Recommend Optune As A Standard Treatment Option For Newly Diagnosed Glioblastoma 7/26/2016
FDA Spurns Ocular Therapeutix (OCUL)'s Post-Operative Eye Pain Treatment 7/25/2016
Vascular Insights Release: NICE Issues Approval Via Interventional Procedure Guidance IPG557 For Endovenous Mechanochemical Ablation For Varicose Veins In The United Kingdom 7/25/2016
Royal Philips Electronics N.V. (PHG) SimplyGo Mini Portable Oxygen Concentrator Conforms To FAA Standards, Now Available For On Board Aircraft Use 7/21/2016
ViraCor-IBT Laboratories's Zika Virus RT-PCR Test Receives Emergency Use Authorization From The FDA 7/20/2016
How Do You Regulate The Digital Health Revolution? 7/19/2016
Intel Custom Foundry Certifies ANSYS, Inc. (ANSS) Simulation Tools For Next-Generation 10nm Tri-Gate Process 7/19/2016
Calgary Scientific Accredited For Web And Mobile Diagnosis Across Asia 7/19/2016
Alere (ALR) HIV Combo Test Receives WHO Prequalification 7/14/2016
EXACT Sciences (EXAS) Release: NCQA Proposes Inclusion Of Cologuard In 2017 HEDIS Quality Measures 7/14/2016
Vascular Insights Release: National Institute For Health And Care Excellence (NICE) Issues Approval Via Interventional Procedure Guidance IPG557 For Endovenous Mechanochemical Ablation For Varicose Veins In The United Kingdom 7/14/2016
FDA Officials Want A National Review System For Medical Devices 7/13/2016
Cynosure (CYNO) Receives Health Canada Authorization To Market SculpSure 7/13/2016
Impact Cryotherapy Leads The Industry With FDA Compliance 7/12/2016
Accelerate Diagnostics (AXDX) Submits De Novo Request To FDA For Accelerate Pheno System And Accelerate Phenotest BC Kit 7/11/2016
Illumina (ILMN) Applauds FDA’s Issuance Of Draft Guidances To Advance Precision Medicine Using Next Generation Sequencing 7/7/2016
Clinical Study Discusses The Value Of C4 Imaging's Sirius Positive-Signal MRI Marker In MRI-Guided Prostate Cancer Treatment 7/6/2016
GenomeDx Biosciences Receives Accreditation From College of American Pathologists 7/6/2016
FDA Grants Bedfont Scientifict Clean Bill Of Health 7/6/2016
EndoGastric Solutions Receives Positive Medical Coverage Policy By HCSC For TIF Procedure With Esophyx Device 7/5/2016
Cepheid (CPHD) Release: FDA Supports Expanded Claims For Xpert Carba-R Test For "Superbugs" 7/1/2016
Brexit Creates Difficulties And Opportunities For UK Pharma And Medical Device Industries 6/30/2016
Biocept, Inc. (BIOC) Comments On Reimbursement Provisions In CMS' Final PAMA Rule 6/29/2016
CareDx (CDNA) Responds To CMS Proposal To Cut AlloMap Pricing By 74% 6/29/2016
BioVentrix Receives CE Marking Certification For Revivent TC, The First Minimally Invasive Heart Failure Treatment To Restore The Left Ventricle 6/27/2016
Medifirst Solutions 510(k) Submission Has Been Accepted By FDA 6/24/2016
NeuroMetrix (NURO) Submits CE Mark Application For Quell Wearable Pain Relief Device 6/22/2016
iCAD, Inc. (ICAD) Commends Final USPSTF Recommendations For Colorectal Cancer Screening Including Computed Tomography Colonography (CTC) 6/22/2016
Newly Issued USPSTF Guidelines For Colorectal Cancer Include Complete Line Of Products From Polymedco 6/22/2016
Rosetta Genomics (ROSG) Receives Approval From New York State For HEME FISH-Based Assays 6/21/2016
FDA Grants Emergency Use Authorization For Hologic (HOLX)'s Aptima Zika Virus Assay 6/20/2016
Veracyte (VCYT) Releases Statement On CMS's Final PAMA Rule 6/20/2016
Alere (ALR) q HIV-1/2 Detect Point-of-Care Molecular HIV Assay Receives WHO Prequalification 6/17/2016
Epigenomics AG' Epi proColon Included In Newly Issued USPSTF Guidelines For Colorectal Cancer Screening 6/16/2016
Allergan (AGN) Announces FDA Acceptance Of The 510(K) Premarket Notification Filing For The XEN Glaucoma Treatment System 6/15/2016
They’re Here: New Draft European Medical Device & IVD Regulations Published 6/15/2016
Echo Therapeutics (ECTE) Announces Institutional Review Board (IRB) Approval Of New Protocol 6/13/2016
FDA Lifts All Remaining Shipping Restrictions At Terumo Cardiovascular Systems' Ann Arbor Facility 6/10/2016
Heart Test Labs Achieves Significant Milestone With ISO 13485 Certification 6/9/2016
NN, Inc. Certifies Additive Manufacturing Technology For Medical Devices 6/9/2016
These Threats Can Take Down a Device Company 6/7/2016
EU Rules on Medical Devices Reached Sooner than We Thought 6/7/2016
Enzo Biochem (ENZ) Announces New York State Approval Of New Women’s Test Based On Proprietary Technology 6/7/2016
Clinical Leaders Reinforce Belief In NGAL For Detection Of AKI Following FDA's Decision On BioPorto's The NGAL Test 6/6/2016
St. Jude Medical (STJ) Cardiomems HF System Is Now Guideline Directed Therapy For Heart Failure Patients In Europe 6/6/2016
Vexos Shenzhen China Facility Achieves ISO 13485:2003 Registration Of Its Quality Management System 6/2/2016
TSO3 (TOS) Responds To U.S. Regulators On Extended Claims And Provides Operations Update 6/2/2016
Maetrics Release: Prompt Adoption Of UDI Needed In Europe To Achieve Seamless Compliance 6/2/2016
Janssen Pharmaceutica N.V. Release: New Idylla Ebola Virus Triage Test Granted Emergency Use Authorization by U.S. FDA 6/1/2016
FDA Panel to Mull Over Expanded Indication for DexCom (DXCM)'s G5 Continuous Glucose Monitor 5/31/2016
NovoCure Receives IDE Approval To Initiate METIS Trial 5/31/2016
BioVentrix Receives FDA IDE Approval For Its Pivotal Clinical Trial, ALIVE 5/31/2016
Pixium Vision Receives Clinical Trial Approval From UK Regulatory Authority For 150 Electrode IRISII Bionic Vision System 5/31/2016
Independent Data Safety Monitoring Board Recommends Continuation Of CytoSorbents REFRESH I Trial 5/27/2016
Is FDA Failing On OB-GYN Device Approvals? 5/26/2016
Coalition Asks FDA To Issue Broad Guidance On Acceptable Irritation Test Methods 5/26/2016
Creative BioMart Introduced Food & Healthcare Test Services 5/23/2016
Rosetta Genomics (ROSG) Receives Approval From New York State For Four PCR-Based Assays 5/23/2016
Intoxalock is Now Certified To Install Ignition Interlock Devices In Florida 5/23/2016
AHA Recommends Robot-Assisted Movement Training And Virtual Reality For Stroke Rehabilitation 5/20/2016
Failure To Report Infuse Data Was Unintentional, Says Medtronic (MDT) 5/19/2016
Ampronix, Manufacturer Of Medical Touch Screens And Innovative Technology, Is Fully ISO 9001 And ISO 13485 Certified - Leaders Within The Medical Industry 5/19/2016
Roche (RHHBY) Submits 510 (K) Filing To FDA For Treponema Pallidum Assay To Aid Clinicians In The Diagnosis Of Syphilis Infection 5/18/2016
CytoSorbents Release: CytoSorb Achieves Final Product Registration In Russia 5/18/2016
Solasia Pharma K.K. Files New Medical Device Application For episil In Japan And China 5/17/2016
Aesica Meets The Serialization Challenge – Novel Modular Solution Complies With All The World’s Differing Regulations 5/16/2016
B.Braun Medical Execs Unhappy Over What They Say is a Lack of Protocol at ECRI Institute 5/13/2016
International Trade Commission To Investigate Chinese Manufacturer BMC Medical's Infringement Of ResMed (RMD) Patents 5/13/2016
Zeus Industrial Products, Inc. Positions Itself For Growth In The Automotive And Aerospace Markets 5/12/2016
Empire Genomics Receives New York State Permit For Molecular Diagnostic And Oncology Clinical Laboratory Testing 5/11/2016
Is FDA Evidence Sufficient To Corroborate Allegations That Theranos Violated Medical Device Regulations? 5/10/2016
BioElectronics Corporation Responds To U.S. FDA's Comments On Its Market Clearance Application 5/10/2016
Ukeru Systems Submit Comments To The FDA On The Need To Immediately Ban The Use Of Electrical Stimulation Devices 5/6/2016
ImmunID Receives CLIA Certification From The US Centers For Medicare & Medicaid Services 5/3/2016
Zika Test From Quest Diagnostics (DGX) Authorized By The FDA For Emergency Use 4/29/2016
B. Braun Medical Taking Leadership Role In Educating Nurses About USP < 800 > 4/29/2016
FDA Spurns Otsuka Pharma, Proteus Digital Health's Drug/Device Combo 4/27/2016
Cerebain Biotech Today Announced It Plans to Seek FDA Approval 4/27/2016
QT Vascular Submits IDE Requesting Permission To Begin Pivotal Trial Of Its Drug-Coated Chocolate Balloon In The United States 4/26/2016
Thermal Gradient Enters Commercial Prototype Testing Phase 4/26/2016
AFter FDA Rejection, TransEnterix (TRXC) Could Turn Focus to Other Surgery Robot 4/22/2016
California Life Sciences Association Applauds Efforts To Increase Patient Access To Breakthrough Medical Technologies 4/22/2016
FDA Craters as the TransEnterix (TRXC) Spurns SurgiBot 510(k) Submission 4/21/2016
FDA Panel Backs Cartiva's Synthetic Cartilage Implant (SCI) 4/21/2016
DermTech Receives CAP Accreditation 4/20/2016
NantOmics Receives Certification From The Centers For Medicare And Medicaid Services And Accreditation From The College of American Pathologists 4/19/2016
Feds Propose Banning Theranos CEO Elizabeth Holmes from the Blood Testing Biz for at Least Two Years 4/18/2016
Renovacare Completes Engineering, Research, And Studies Required To File 510(K) Submission To The FDA For Its Novel Medical-Grade Liquid Spray Device 4/12/2016
Royal DSM’s Dyneema Purity Fibers Meet Revised ASTM F2848-16 Material Specifications For Medical-Grade UHMWPE Yarns 4/11/2016
NetBio Announces Its DNAscan System Is The First And Only Rapid DNA Product To Earn NDIS Approval From The FBI 4/7/2016
Toshiba America Medical Systems's Aplio Platinum Series Ultrasound Authorized As Secure By U.S. Department Of Defense 4/7/2016
Mevion Medical Systems Brings Proton Therapy To Central Florida 4/6/2016
Ortho Kinematics Becomes ISO 13485-Certified And Clears FDA Audit 4/6/2016
American Optometric Association Complaint Urges FDA Enforcement Of Device Standards On Vision "App" 4/5/2016
ConforMIS Withdraws Application as the FDA Raises Questions on iTotal Hip 4/4/2016
SGS Life Science Services (SGSN) Release: Introducing the New Revision of ISO 13485 Standard: Medical Devices – Quality Management System – Requirements for Regulatory Purposes 4/1/2016
Freshloc Technologies Releases Fast Budget Check-Up Tool For Healthcare Supply Chain To Quote Regulatory Compliance For Temperature Monitoring 4/1/2016
Roche (RHHBY) To Initiate Testing For Zika Virus At U.S. Blood Centres Under FDA Investigational New Drug Application Protocol 3/31/2016
FDA Allows Use Of Investigational Test To Screen Blood Donations For Zika Virus 3/31/2016
Precision Biopsy Submits Investigational Device Exemption (IDE) Application To The FDA To Expand Clinical Trial Of Its Claricore Biopsy System In Prostate Cancer Patients 3/30/2016
Quest Diagnostics (DGX) Marlborough Lab Earns LEED Green Building Certification 3/29/2016
TissueGen, Inc. Announces ISO13485:2003 Certification And Record Growth Driven By ELUTE Fiber 3/28/2016
TransEnterix Says FDA Isn't Finished Reviewing SurgiBot Application 3/25/2016
Carestream Health Submits Application For FDA 510(K) Clearance For Its Onsight 3D Extremity System 3/24/2016
BioCorp: Announces Eligibility PEA-SME For 2016/2017 3/24/2016
Freshloc Technologies Launches Tool To Quote Compliance With CDC Guidelines For Temperature Monitoring 3/22/2016
Immunetics, Inc. BacTx Test Helps Hospitals Meet FDA Proposed Changes in Platelet Bacteria Testing Practices 3/21/2016
U.S. Medical Device Inspections Down In 2015, FDA Reports 3/18/2016
FDA Panel Backs Abbott (ABT)'s Dissolving Stent 3/16/2016
Cerus (CERS) Announces The Inclusion Of Pathogen Reduction Technology In FDA’s Revised Guidance Document On Bacterial Safety Standards For Platelets 3/15/2016
FDA Wants TSO3 (TOS) to Evaluate Claims Based on the Type and Manufacture of Device 3/14/2016
Toro Management, LLC DBA SYLK Announces That Its Product SYLK Has Received Its FDA 510(K) Clearance As A Class II Medical Device 3/14/2016
Natera Release: American Medical Association Grants New CPT Code For Microdeletion Testing 3/11/2016
UL Provides Medical Device Manufacturers Alternative To Traditional CFDA Testing 3/10/2016
Royal Philips Electronics N.V. (PHG) Meets Stringent U.S. Government Security Requirements For Pathology Medical Data 3/10/2016
Enzo Biochem (ENZ) Submits AmpiProbe Based Assay Targeted At Women’s Health For Approval To New York State Department Of Health 3/10/2016
Allergan (AGN) Receives Complete Response Letter From FDA For Prior Approval Supplement For RESTASIS (Cyclosporine Ophthalmic Emulsion) 0.05% Multi-Dose Preservative-Free Bottle 3/10/2016
Titan Pharma (TTP) Receives Feedback From FDA On Ropinirole Implant Development Program For Parkinson's Disease 3/8/2016
Inari Medical Announces IDE Approval To Study The FlowTriever System For The Treatment Of Pulmonary Embolism 3/8/2016
Corvia Medical Receives IDE Approval For REDUCE LAP-HF I Clinical Study & Announces Agreement With Strategic Partner For Exclusive Option To Purchase Company 3/7/2016
Avita Medical Announces U.S. FDA Approval For Increase In Compassionate Use Of ReCell Patient Cases 3/7/2016
Solos Endoscopy, Inc. (SLSE.PK) FDA Establishment Registration & Device Listing Renewed For 2016 3/3/2016
Circulogene Theranostics Accepts First International Orders For Cell-Free DNA Liquid Biopsy Testing 3/2/2016
Bedfont Scientific Responds to FDA's Decision to Temporarily Detain Its Products 3/1/2016
Olympus Corporation Of The Americas And Subsidiary Reach Settlement Agreements With U.S. Department Of Justice 3/1/2016
InVivo Therapeutics (NVIV) Announces FDA Acceptance Of A Modular Submission And Review Process For The Neuro-Spinal Scaffold 3/1/2016
MiMedx Supports FDA's Decision To Postpone April 13th Hearing On Draft Guidance Documents 3/1/2016
Firstkind, A Sky Medical Technology Company, Is Delighted To Announce RCN Accreditation Of Its User Training Programme For The geko Device For VTE Prevention 2/25/2016
Luminex (LMNX) Receives Medical Device License For ARIES System And ARIES HSV 1&2 Assay In Canada 2/23/2016
BioConnected Licenses Valencell's PerformTek Sensor Technology To Bring Next-Gen "Smart" Earphones To Market 2/23/2016
Medicare Contractor Will Not Cover St. Jude Medical (STJ)’s Cardiomems Heart Monitor 2/22/2016
Smiths Medical, Inc. Receives Innovative Technology Designation From Vizient For CADD-Solis V3.0 PIB Ambulatory Infusion Pump 2/18/2016
Rosetta Genomics (ROSG) Receives Approval From New York State For First-Of-Its-Kind Thyroid Cancer Diagnostic Assay 2/18/2016
Evana Automation Launches New Validation Program To Assist Healthcare Product Manufacturers With Meeting FDA Regulations During The Implementation Of Automated Manufacturing Equipment 2/17/2016
Neogen Corporation (NEOG)'s ANSR For Listeria Receives AFNOR Validation 2/16/2016
National Institute for Clinical Excellence (NICE) Okays Medtronic (MDT) Veo System for Certain Type 1 Diabetics 2/12/2016
NeoChord Again Awarded NUB Status 1 In Germany 2/10/2016
Bluestar Silicones Achieves ISO 8 And ISO 7 Clean Room Certification; Promotes Long-Term Implant Offering At MD&M West 2/9/2016
Admera Health Receives CLIA Approval For Its Breakthrough Liquid Biopsy Testing Platform 2/9/2016
Cartiva Announces Tentative Date Of FDA Advisory Panel Review Of Cartiva SCI 2/8/2016
Angel Medical Systems Announces FDA Advisory Committee Meeting For Review Of The Angelmed Guardian System 2/8/2016
HeartStitch Passes Critical Regulatory Audit in Kazakhstan 2/5/2016
SMTC’s Dongguan, China Facility Awarded ISO 13485 Certification For Medical Devices 2/2/2016
Intersect ENT Announces NUB Status 1 Designation For PROPEL Sinus Implant In Germany 1/29/2016
Veracyte (VCYT) Receives Regulatory Authorization To Offer Percepta Bronchial Genomic Classifier For Patients In New York State 1/28/2016
BioLineRx Ltd. Receives Confirmation Of Medical Device Classification In Europe For Celiac Treatment 1/25/2016
Zecotek Photonics Inc. Granted U.S. Notice Of Allowance For Enhanced LFS Crystal Array Manufacturing 1/15/2016
New Senate Report Says FDA Fails to Make Sure Medical Devices are Safe 1/14/2016
BioAmber Inc. Sarnia Certified To ISO 9001, ISO 14001, OHSAS 18001 And FSSC 22000 1/14/2016
Intouch Solutions Certified As Level Four Veeva Systems, Inc. Multichannel Content Partner 1/13/2016
Olympus (OCPNF) Releases Statement In Response To US Senate HELP Committee Report 1/13/2016
Claritas Genomics Awarded International Organization For Standardization (ISO) Accreditation For Molecular Diagnostic Testing From The American Association For Laboratory Accreditation (A2LA) 1/7/2016
MiMedx Receives Certificate From FDA Allowing The Export Of MiMedx Allografts 1/6/2016
Easton Pharmaceuticals (OP: EAPH) Provides Regulatory Filing Update For Its EvaPro (VS-Sense) Women's Diagnostic Product And Provides Updates On The Marketing And Sales Of Currently Approved Products For Most Latin American Markets 1/6/2016
Novation Announces Product Categories For Period 1 National Group Buys Program 1/4/2016
Materialise Receives FDA NSE Letter for X-Ray 510(k) Submission 12/22/2015
CytoSorbents, Inc. Issues EAP Update 12/22/2015
SunPharm (SUNP) Slumps After U.S. FDA Warning for Halol Plant 12/21/2015
AMP Responds To FDA Report On Oversight Of Laboratory Developed Testing Procedures 12/16/2015
Clontech Laboratories, Inc. Earns ISO 13485:2003 Certification 12/14/2015
CombiMatrix (CBMX)'s Array For Pre-Implantation Genetic Screening Granted Conditional Approval From New York State Department Of Health 12/10/2015
Spectranetics (SPNC) Announces FDA Submission Of Bridge Occlusion Balloon For Lead Extraction Procedures 12/9/2015
Vericel (ASTM) Submits HDE Supplement To The FDA To Revise The Labeled Indications For Use And Add Pediatric Labeling For Epicel 12/8/2015
Diagnomics And Maverix Biomics Achieve CLIA Validation For Clinical Diagnostic Pre-Natal Testing 12/8/2015
Blue Earth Diagnostics And Siemens (SI)’ PETNET Solutions Announce FDA Acceptance Of NDA Filing For Fluciclovine 12/2/2015
Avinger Announces Filing Of 510(K) Application For Enhanced Version Of Pantheris 12/2/2015
Cesca Therapeutics Receives Approval For Medicare Coverage 12/2/2015
Toshiba America Medical Systems’s MR Portfolio Is First To Meet Network Security Guidelines Of The U.S. Department Of Defense 12/2/2015
MetaStat Receives CLIA Certification From The Centers for Medicare & Medicaid Services 11/30/2015
Beckman Coulter Life Sciences Release: Aquios CL Flow Cytometer Accepted By WHO Prequalification Of In Vitro Diagnostics Programme 11/30/2015
SkylineDx Receives CE-IVD Mark For MMprofiler -- Its Innovative Gene Signature-Based Test For Multiple Myeloma 11/25/2015
Boston Scientific (BSX)'s Watchman May Catch a Break 11/24/2015
ADM Tronics (ADMT) Withdraws FDA App for Angiodroid CO2 Injector for Angiography 11/23/2015
Advanced Bionics Corporation Receives TÜV Approval for the Naída CI Q Series Of Sound Processors 11/20/2015
Meridian Bioscience (VIVO) Receives FDA Clearance For New Molecular Whooping Cough Test Claims 11/19/2015
Endologix Release: Leading Physicians To Initiate ASCEND Registry For Nellix EVAS System 11/18/2015
Enzo Biochem (ENZ) Announces New York State Approval Of Its First Assay Based On Ampiprobetm Platform Aimed At Providing Affordable Molecular Diagnostics In Light Of Reimbursement Pressure 11/17/2015
Advanced Medical Isotopes Corporation Reports Progress Towards Seeking FDA Clearance For The Y-90 Radiogel Device 11/17/2015
Stock Slides as Boston Scientific (BSX)'s Watchman Hit by Restrictive CMS Coverage Decision 11/12/2015
Opko Health (OPK) 4Kscore Test Receives Category I CPT Code Approval 11/12/2015
Amedica Corporation Submits 24-Month Clinical Data To FDA For Clearance Of Composite Interbody Spinal Device 11/11/2015
NeuroMetrix (NURO)’ Quell Wearable Pain Relief Device Receives American Podiatric Medical Association (APMA) Seal Of Approval 11/11/2015
Alere (ALR)'s SD BIOLINE HIV/Syphilis Duo Is First Dual Test To Receive WHO Prequalification 11/9/2015
PTS Diagnostics ' Patent Enforcement Against Jant Pharmacal Gains Momentum 11/6/2015
FDA Draft Guidance May Have Caught MiMedx Off-Guard 11/4/2015
ALung Receives Expedited Access Pathway Designation From FDA For Hemolung Respiratory Assist System 11/4/2015
Nuo Therapeutics Responds To Favorable CMS Hospital Outpatient Payment Final Ruling For Aurix System 11/2/2015
FDA Reports From Lab Visits Highlight Problems at Theranos 10/29/2015
TearScience, Inc. Announces New Pricing Strategy For Core LipiFlow Technology Used For Treatment Of Dry Eye From Meibomian Gland Disease (MGD) 10/28/2015
EDP Biotech Achieves ISO 13485 Certification 10/28/2015
Cynosure (CYNO) Receives Health Canada Authorization To Market MonaLisa Touch For Genitourinary Syndrome Of Menopause 10/28/2015
Nephros Inc. (NEP) Announces FDA 510(k) Submission Of S100 Ultrafilter 10/27/2015
Amsel Medical Announces Filing Of 2nd 510(K) Pre-Marketing Notification With The US Food And Drug Administration For The Amsel Occluder Device 10/27/2015
SHINE Medical Technologies Achieves Major Milestone On Path To Construction Permit Approval 10/26/2015
Cartiva Announces GMP Certification By Brazil's ANVISA 10/26/2015
TSO3 Allowed Expanded Claims For Revolutionary STERIZONE VP4 Sterilizer 10/26/2015
Theranos Continues to Battle Wall Street Journal Critics, Says FDA Made Unannounced Inspections 10/23/2015
Tryton Medical Nears FDA Submission for Stent 10/23/2015



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