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Medical Dev. & Diag. - Regulatory
Vascular Solutions (VASC), CEO Get Ready to Take on FDA Conspiracy Charges 3/31/2015
Cepheid (CPHD) Receives Emergency Use Authorization From FDA For Xpert Ebola Diagnostic Test 3/25/2015
Simplify Cervical Artificial Disc Receives IDE Approval 3/18/2015
NanoString (NSTG)' Prosigna Breast Cancer Assay Included In German Breast Cancer Treatment Guidelines 3/18/2015
SCIENION US, Inc. Receives ISO 13485 Certification 3/18/2015
Accelerate Diagnostics (AXDX) Achieves ISO 13485 Certification And Initial Installations Of Accelerate ID/AST System 3/17/2015
Mauna Kea Technologies Receives Additional CPT Reimbursement Code In The U.S. Supporting Key Application Of Endomicroscopy With Cellvizio In The Biliary Tract 3/17/2015
Ontrion Medical Device Batteries Receive Safety CB Test Certificate IEC 62133 3/13/2015
Enzo Biochem (ENZ) Announces New York State Approval Of First Flowscript Assay For Improved Detection Of Cervical Cancer Progression 3/13/2015
FDA Now Requires Proof That Reusable Medical Devices Can Be Reliably Cleaned 3/13/2015
Olympus Corporation Fought With the FDA for Tighter Rules for Devices That Spread Superbugs 3/11/2015
Medigus (MDGS.TA) Announces American Medical Association Publication Of Category I CPT Code For Esophagogastric Fundoplasty Trans-Orifice Procedures 3/11/2015
FDA Wants AcelRx (ACRX) to Run Another Trial on Zalviso Drug-Device Combo 3/10/2015
EndoGastric Solutions, Inc. Announces American Medical Association’s Publication Of New Category I CPT Code For Esophagogastric Fundoplasty Trans-Orifice Procedure 3/10/2015
Intrinsic Imaging Awarded Interventional Medical Device Trial For Prevention Of Pulmonary Emboli 3/4/2015
Calgary Scientific Release: ResolutionMD Receives Class II Certification For Web And Mobile Diagnosis In Japan 3/3/2015
C.R. Bard Release: CMS Approves Pass-Through Payment For Lutonix DCB For Outpatient Use 2/20/2015
Maquet Cardiovascular LLC Agrees to Hire Outside Inspectors in Deal With the FDA 2/20/2015
Oncore Manufacturing Receives ISO13485 Certification And IPC J-STD-001 QML/ Qualified Manufacturer List At Its Suzhou, China Facility 2/19/2015
Five Apple (AAPL) Execs Meet With Mexican Regulators Ahead of Smartwatch Debut 2/18/2015
ALR Technologies Inc. Seeks FDA Approval For Insulin Dose Adjustment Feature For Better Diabetes Management 2/17/2015
Avedro, Inc. Announces Date For FDA Advisory Committee Meeting 2/17/2015
Vermillion Receives ISO 13485 Certification For Company's Quality Management System 2/13/2015
True Diagnostics, Inc. Completes FDA Pre-Submission For TrueDX(TM)-TSH Test 2/13/2015
Amedica Corporation Submits 510(K) Application To FDA For Composite Spinal Interbody Spacers With Porous Silicon Nitride Center 2/12/2015
Vital Connect Receives Medical Device Ninsho Certification To Market Healthpatch MD In Japan 2/12/2015
Zimmer (ZMH) Provides Update On The European Commission (EC) Review Process Relating To The Pending Merger With Biomet Inc. 2/10/2015
Nanotherapeutics Receives Expanded 510(K) Marketing Clearance From The FDA For Nanofuse DBM 2/10/2015
Advanced Prenatal Therapeutics Receives Notice Of Allowance For Preeclampsia Device 2/9/2015
Akers Biosciences, Inc.' Management System Certified To ISO 13485 (2003) 2/9/2015
FDA Denies Venaxis, Inc. (APPY)'s Appendicitis Test 510(k) Submission 1/29/2015
MagForce AG And Magforce USA, Inc. Announce FDA Pre-IDE Meeting On Magforce's Nanotherm™ Prostate Cancer Therapy Pre-Submission 1/27/2015
Apple (AAPL) Watch Is a Wellness Tool, Not a Medical Device: FDA 1/22/2015
FDA Officially Clears Integra LifeSciences Holdings Corporation (IART)'s Plant Problems 1/21/2015
FDA Warns Philips Respironics on Malfunction Reporting 1/20/2015
GE Healthcare And NextGen Healthcare First To Achieve EHNAC's Practice Management System Accreditation 1/20/2015
After Public Shaming in 2013, 23andMe Aims to End FDA Standoff 1/13/2015
FDA Waiver Of Alere Inc. (ALR)'s Flu Test Poses Threat to Cepheid (CPHD) 1/13/2015
QIAGEN Inc. (QGEN) Announces First-Ever Regulatory Registration Of A Lung Cancer Companion Diagnostic Based On Liquid Biopsies 1/12/2015
Isotope Technologies Garching Received Manufacturing Authorization For Ga-68 Generator 1/12/2015
FDA Lifts Import Ban on Hospira, Inc.'s Infusion Pumps 1/9/2015
Chipscreen Biosciences Announces CFDA Approval Of Chidamide (Epidaza) For PTCLs In China 1/9/2015
ANSYS, Inc. (ANSS) SCADE Receives ISO 26262 Qualification 1/8/2015
Biocept, Inc. (BIOC)'s Proprietary Oncology Diagnostics To Be Offered On America's Choice Provider Network 1/7/2015
1} Receives Positive Coverage Decision For Allomap® From Two Additional Medicare Administrative Carrier Jurisdictions 1/7/2015
Medytox Diagnostics Awarded License To Begin Lab Testing In New York State 1/7/2015
FDA Grants Faustus Forschungs Cie. Translational Cancer Resea Humanitarian Use Device (HUD) Designation 1/6/2015
Empowered Products Receives European CE Certification For PINK® And Gun Oil® Brands Of Personal Lubricants As Class 1 Medical Devices 1/6/2015
Cancer Genetics, Inc. (CGIX) Receives Approval To Provide Oncology Testing For Patients In California 1/5/2015
Cesca Therapeutics Receives Feedback From the FDA on Its Pivotal Investigational Device Exemption ("IDE") Application for Treating Critical Limb Ischemia ("CLI") 1/2/2015
FDA Seeks Additional Info on Cesca Therapeutics's Pivotal IDE Application for Treating CLI 1/2/2015
CytoSorbents, Inc. Submits IDE Application To FDA For U.S. Cytosorb® Cardiac Surgery Trial 12/30/2014
Carestream Health, Inc. Is First Company To Receive U.S. Navy Certification To Implement Medical Image Management Systems 12/22/2014
IRadimed Corporation Resumes Domestic Distribution Of Infusion Pumps 12/22/2014
FDA Mulls Using Drones To Conduct Site Inspections 12/19/2014
Trinity Biotech (TRIB) Announces CLIA Waiver Of Rapid Syphilis Test 12/17/2014
Cohera Medical, Inc. Receives Priority Review Status Designation From FDA For Sylys Surgical Sealant 12/17/2014
Amway Release: eSpring Brand Is First To Be Certified To All 15 New NSF/ANSI 401 Emerging Contaminants 12/15/2014
VertiFlex Announces FDA Advisory Panel Meeting For The Superion® Interspinous Spacer System 12/12/2014
Response Genetics, Inc. Secures New York State Department Of Health Approval For The Company's Responsedx® Testing Services 12/11/2014
FDA Postpones Panel Meeting For VertiFlex's Superion Spine Device 12/10/2014
Intrinsic Therapeutics Completes Major Regulatory And Clinical Milestones 12/9/2014
Cohera Medical, Inc. Submits Investigational Device Exemption To FDA For Clinical Trial Of Its Sylys Surgical Sealant 12/9/2014
U.S. FDA Grants CLIA Waiver For Alere Determine HIV-1/2 Ag/Ab Combo Test 12/9/2014
Eternity Healthcare Release: FDA Approves A Safer Way To Administer Vaccines 12/9/2014
Violations Are Isolated Incidents: AngioDynamics (ANGO) CEO Says 12/8/2014
WuXi PharmaTech Co., Ltd. Subsidiary Submits Application To The National Equities Exchange And Quotations In China To List On The New Third Board 12/4/2014
Mainstay Medical (MSTY.PA) Achieves Quality System Certification 12/3/2014
Ekso Bionics (EKSO) To Submit 510(k) Notification In December 12/3/2014
AngioDynamics (ANGO) Cited For Safety Violations 12/2/2014
Novocure Announces FDA Approval Of An IDE Supplement Allowing All Control Patients In Its Phase 3 Trial In Newly Diagnosed GBM To Cross Over To Receive Tumor Treating Fields 12/2/2014
Medtronic, Inc. (MDT) Selling Bonds For Covidien (COV) Acquisition 12/1/2014
Federal Trade Commission Gives Medtronic, Inc. (MDT), Covidien (COV) Merger The Green Light 12/1/2014
Nanomix, Inc. Receives ISO 13485:2003 Certification 12/1/2014
SpineGuard Successfully Passes ANVISA’s Inspection, Paving The Way For Registration Of Its New Products In Brazil 12/1/2014
Vela Diagnostics Announces The Listing Of Their Next-Generation Sequencing System With The U.S. FDA As A Class II Medical Device 12/1/2014
IRadimed Corporation Files 510(K) Submission For Premarket Notification 11/25/2014
Nanomix, Inc. Receives ISO 13485:2003 Certification 11/25/2014
FDA Strengthens Warning On Tool For Fibroid Surgeries 11/24/2014
ZOLL Medical Corporation (ZOLL) Files With Japan’s Pharmaceuticals And Medical Devices Agency For New Indication For Intravascular Temperature Management Technology 11/21/2014
Sanmina India Design Center Awarded Latest ISO 13485 Design Certifications For Medical Devices 11/20/2014
Great Basin Scientific, Inc. Submits 510(K) Application To FDA For Group B Strep Assay 11/19/2014
Terumo BCT And Banco de Sangre de Servicios Mutuos Unite In A Treatment Use Program Developed To Help Improve Blood Supply Safety Using An Investigational Device 11/19/2014
EPA Conclusion On Sterilizer Could Disrupt Medical Device Supply, Companies Say 11/18/2014
Vela Diagnostics Announces The Listing Of their Next-Generation Sequencing System With The U.S. FDA As A Class II Medical Device 11/12/2014
Medtronic, Inc. (MDT) Offers EU Concessions In $43 Billion Covidien (COV) Deal 11/11/2014
Rhinomed (ASX:RNO) Turbine Achieves CE Mark Registration 11/11/2014
NeuroSigma, Inc. Receives Notice Of Allowance From The Mexican Institute Of Industrial Property Covering Subcutaneous Trigeminal Nerve Stimulation (sTNS) 11/3/2014
Alliqua Biomedical (ALQA)'s Biovance® Assigned Level II HCPCS Q Code For Product Reimbursement 11/3/2014
Abiomed (ABMD) Surges On FDA Deal For Impella Indication 10/31/2014
Chembio Diagnostics, Inc. (CEMI.OB)'s DPP® HIV 1/2 Assay Receives CLIA Waiver From FDA 10/30/2014
InspireMD Ltd. Investigational Device Exemption (IDE) Amendment Approved By The FDA 10/30/2014
AngioDynamics (ANGO) Release: NanoKnife System Receives OPS Procedure Classification Codes In Germany 10/28/2014
Myriad Genetics, Inc. (MYGN) Announces Inclusion Of Prolaris® Test In NCCN Guidelines 10/27/2014
Biodesix, Inc. Announces Inclusion Of Veristrat In Updated NCCN Guidelines 10/24/2014
Ivera Medical Corporation Successfully Completes FDA Inspection 10/21/2014
bioMerieux SA Working To Get FDA Approval For Ebola Screening Test 10/21/2014
Cerus Corporation (CERS) Submits Compassionate Use IDE Supplement For INTERCEPT Blood System Treatment Of Ebola Convalescent Plasma 10/20/2014
Hunter Technology Licensed By CA Food And Drug Branch To Manufacture Finished Medical Devices For Oems; EMS Adheres To Stringent Quality Standards On Path To FDA Registration 10/16/2014
Otoharmonics Corporation Release: Levo Tinnitus System Receives Health Canada License As A Class 2 Medical Device 10/16/2014
FDA Panel Cautiously Recommends Boston Scientific Corporation (BSX)’s Heart Device 10/10/2014
RTI Surgical (RTIX) Receives Letter From FDA On Map3® Cellular Allogeneic Bone Graft 10/9/2014
Materialise's Heartprint® Now Listed As A Class 1 Medical Device 10/9/2014
FDA Doubtful On New Watchman Data From Boston Scientific Corporation (BSX) 10/8/2014
Can Chocolate Bars With Silver Nanoparticles Cure Ebola? FDA Commissioner Riffs On Fraud 10/8/2014
FDA Green Lights Integra LifeSciences Corporation (IART) Puerto Rico Plant 10/8/2014
FDA Accepts IDE Submission By Cerus Corporation (CERS) Making The INTERCEPT Blood System Available To Address Chikungunya And Dengue Blood Safety Risks 10/7/2014
Proposed Merger Of Zimmer Holdings, Inc. And Biomet Inc. To Enter Second Phase Review By European Commission 10/3/2014
FDA Issues New Guidelines For Medical Devices' Cybersecurity 10/2/2014
Alere Inc. (ALR) Release: Entamoeba histolytica Rapid Test Receives CE Mark 10/2/2014
Helius Medical Technologies Announces Health Canada Approval To Start Investigational Testing For The Pons™ Device 10/2/2014
Avedro, Inc. Announces Resubmission Of New Drug Application To FDA For Corneal Cross-Linking 9/30/2014
AltheaDx Receives Approval From New York State For IDgenetix Tests 9/29/2014
Medina Medical Announces CE Mark For Its Embolization Coil 9/25/2014
VertiFlex Scores FDA Panel Date For Superion Interspinous Spacer 9/24/2014
World Health Organization Issues Prequalification Of Becton, Dickinson and Company (BDX) FACSPresto™ Near-Patient CD4 Counter System For HIV/AIDS Monitoring 9/24/2014
Sophia Genetics Receives CE-IVD Mark For Genetic Testing Of Familial Mediterranean Fever And Hypercholeteromia 9/24/2014
Atossa Genetics, Inc. (ATOS) Provides Regulatory And Commercial Update On Its ForeCYTE Breast Aspirator And Its FullCYTE Breast Aspirator 9/24/2014
T2 Biosystems (TTOO) Receives FDA Authorization To Market T2Candida And T2Dx For The Detection Of Sepsis-Causing Pathogens 9/23/2014
GHX Successfully Submits Product Data To The FDA Production Global UDI Database (GUDID) Ahead Of Deadline 9/23/2014
World Health Organization Issues Prequalification Of Becton, Dickinson and Company (BDX) FACSPresto™ Near-Patient CD4 Counter System For HIV/AIDS Monitoring 9/23/2014
Thermo Fisher Scientific (TMO) Announces Listing Of The Ion PGM Dx System With The U.S. FDA As Class II Medical Device 9/18/2014
Neuromod Secures ISO Certification Ahead Of Multisensory Tinnitus Treatment Launch 9/18/2014
IRadimed Corporation Announces Conference Call To Discuss The Status Of The Recent FDA Warning Letter 9/16/2014
Breathe Technologies, Inc. Receives CE Mark Approval For Non-Invasive Open Ventilation (NIOV) System 9/9/2014
Boyd Corporation Receives ISO 13485:2003 Quality Certification For Medical Devices 9/8/2014
Intertek’s Boxborough, MA Laboratory Receives A2LA Scope Expansion For Mechanical And Environmental Testing 9/8/2014
New Society of Healthcare Epidemiology Of America (SHEA) Guidelines Include Agion Antimicrobial-Treated Catheters 9/3/2014
FDA Clears St. Jude Medical (STJ)'s Texas Neuromodulation Plant 8/27/2014
Boston Scientific Corporation (BSX) Lands Third Date With FDA Panel For Watchman Stroke Device 8/26/2014
Royal Philips Electronics N.V. (PHG) Receives FDA 510(K) Clearance For TAVI Precision Treatment Planning Application 8/21/2014
IMRIS Receives Health Canada Licensing For Integrating Latest Generation MR Scanners Within VISIUS Surgical Theatre 8/21/2014
Atossa Genetics, Inc. (ATOS) Announces Submission Of Additional Information To The FDA In Support Of 510(k) For The ForeCYTE Breast Aspirator 8/21/2014
Exco Intouch Achieves Quality Milestone With Iso9001:2008 Certification 8/21/2014
FDA Approves Changes To Covidien plc (COV) Recalled Devices 8/21/2014
Molex Dongguan China Achieves FDA Registration For Class I Medical Devices 8/19/2014
Congress Makes Move To Punish Medtronic, Inc. (MDT) And Other"Corporate Deserters" 8/7/2014
FDA Will Regulate Thousands Of Cancer, Genetic, And Other Diagnostic 8/5/2014
EDAP TMS S.A. (EDAP) Comments On FDA Panel Vote 8/5/2014
CardioMEMS Heart Failure Monitoring System Receives Approval From CMS For New Technology Add-On Payment 8/5/2014
FDA Panel In Favor Of Cohera Medical, Inc.'s TissuGlu® Surgical Adhesive 8/4/2014
ACLA Expresses Concern With FDA Guidance On Laboratory Developed Tests (LDTs) 8/1/2014
FDA Bans Medtech 510(K) Pathway's "Split Predicates" 8/1/2014
EDAP TMS S.A. (EDAP) Did Not Provide Enough Evidence That Prostate Cancer Device Is Safe: FDA 8/1/2014
CombiMatrix Corporation (CBMX)'s SNP-Based Miscarriage Analysis Test Granted Conditional Approval From New York State Department Of Health 7/31/2014
SAGE Labs Licenses CRISPR/Cas9 Technology From The Broad Institute 7/29/2014
FDA Staff Questions EDAP TMS S.A. (EDAP)'s Prostate Cancer Device 7/29/2014
FDA Rejects Redwood City's AcelRx Pharmaceuticals (ACRX) Painkiller Dispensing Device; Stock Plunges -34.35% At 9:37AM ET 7/29/2014
Amniox Medical's NEOX® And CLARIX® Product Lines Receive American Podiatric Medical Association (APMA) Seal Of Approval 7/24/2014
Varian Medical Systems (VAR)' ARIA® Oncology Information System Certified For Use To Demonstrate Stage 1 And 2 "Meaningful Use" Of An Electronic Health Record 7/22/2014
Apex Medical, Inc.'s Respiratory Therapy Product Receives Affirmation From USITC 7/21/2014
White House Puts Up Roadblock To Stop Medtronic, Inc. (MDT)'s Irish Tax Strategy 7/18/2014
St. Jude Medical (STJ) Clears FDA Issues At California Plant 7/17/2014
bioTheranostics Receives Approval To Perform Breast Cancer Index Testing For Patients In State Of New York 7/16/2014
Venaxis, Inc. (APPY) Reports On Recent FDA Submission Activities 7/16/2014
CombiMatrix Corporation (CBMX)'s Pediatric Development Disorders Analysis Test Granted Conditional Approval From New York State Department of Health 7/15/2014
FDA Berates Philips Healthcare (PHG) Respironics Over Infant Sleep Monitor Manufacturing 7/14/2014
Asuragen, Inc. Receives New York State License For Molecular Genetic And Oncology Clinical Laboratory Testing 7/10/2014
HeartWare (HTWR) Warning Letter Details Inadequate Responses 7/9/2014
ViaCyte, Inc. (Formerly Known as Novocell, Inc.) Achieves Significant Milestone With ISO 13485:2003 Certification For Its Encaptra Drug Delivery System 7/8/2014
St. Jude Medical (STJ) Resolves 2013 FDA Warning Letter 7/2/2014
Zimmer Holdings, Inc. And Biomet Inc. Receive Requests For Additional Information From Federal Trade Commission 7/2/2014
St. Jude Medical (STJ) Resolves FDA Warning Letter For Sylmar Facility 7/2/2014
Nephros Inc. (NEP) Announces FDA 510(k) Submission Of DSU-H And SSU-H Ultrafilters To Be Used To Filter EPA Quality Drinking Water To Remove Microbiological Contaminants And Waterborne Pathogens 7/1/2014
ReShape Medical Submits PMA Application To FDA For Non-Surgical Weight Loss Device 7/1/2014
GE Healthcare Release: CHMP Recommends EU Approval Of VIZAMYL™ (Flutemetamol F18 Injection) For PET Imaging Of Beta Amyloid Plaque 6/30/2014
Signal Genetics LLC (SGNL) Obtains New York State Approval For MyPRS® Multiple Myeloma Prognostic Test 6/30/2014
EDAP TMS S.A. (EDAP) Completes FDA Inspection of Manufacturing Site 6/27/2014
Atossa Genetics, Inc. (ATOS) Receives Quality Registration Certificates ISO 13485:2003; EN ISO 13485:2012 And AC:2012 (Canadian); And ISO 9001:2008 6/26/2014
Smith & Nephew Inc. (SNN) Halts U.S. Renasys™ Sales Amid FDA Snafu 6/24/2014
Medtronic, Inc. (MDT) Targeted By Hackers, Lost Patient Records 6/24/2014
Yet Another Delay For Boston Scientific Corporation (BSX)'s Watchman Device 6/18/2014
FDA Panel Mixed On EnteroMedics (ETRM)'s Implanted Weight-Loss Device 6/18/2014
Agena Biosciences Announces FDA 510(k) Premarket Clearance Of The IMPACT Dx™ Factor V Leiden And Factor II Genotyping Test On The IMPACT Dx™ System 6/17/2014
ERT’s AM3® Is First Integrated Home Spirometer/eDiary Authorized To Administer Standardized Asthma And COPD Instruments 6/17/2014
Dehaier Medical Systems Ltd. (DHRM) Patented Tele-Consultation Management System V1.0 Software Copyright 6/16/2014
Sequenom Inc. (SQNM) Receives U.S. FDA Premarket Clearance 6/16/2014
Eutropics Pharmaceuticals Laboratory Receives CLIA Certification 6/16/2014
Apple (AAPL) Discussed "Moral Obligation" To Mobile Health In Secret FDA Meeting 6/13/2014
FDA Panel OKs C.R. Bard's Lutonix Balloon 6/13/2014
NeuroMetrix, Inc. (NURO) Files For China Approval Of Peripheral Neuropathy Test 6/12/2014
Elekta's MOSAIQ Oncology Information System Receives Stage 2 Meaningful Use Certification 6/11/2014
Pulsar Vascular Receives FDA IDE Approval For The Pulserider® Aneurysm Neck Reconstruction Device For The Treatment Of Intracranial Bifurcation Aneurysms 6/10/2014
NeuroMetrix, Inc. (NURO) Submits Regulatory Application For NC-stat DPNCheck In China 6/10/2014
Polyzen Expands Cleanroom Film Operations For Regulated Medical Devices 6/6/2014
Medline Industries, Inc. Will Reopen H&P/Triad Plant That Was Closed After Contamination Woes 6/6/2014
T2 Biosystems Submits 510(K) Application To The FDA For Review Of T2Dx And T2Candida 6/3/2014
Immucor Announces Lifting Of FDA NOIR 6/2/2014
Active Implants Corporation Release: FDA Has Granted Investigational Device Exemption (IDE) Approval To Conduct A Pivotal Clinical Trial Of The Nusurface® Meniscus Implant For Early Knee Osteoarthritis 5/29/2014
China Fines Johnson & Johnson (JNJ) And Others For Price Fixing 5/29/2014
Cothera Receives ISO 13485 Certification 5/29/2014
TrovaGene, Inc.'s Precision Cancer Monitoring Technology Referenced In Multi-Disciplinary Clinical Consensus Guidelines 5/28/2014
BioTime (BTX) Receives ISO 13485 Certification For Medical Devices 5/28/2014
Emerging Medical Device Firm Advanced Cooling Therapy Receives License For Commercial Sale Of Its Novel Esophageal Cooling Device In Canada 5/28/2014
EDAP TMS S.A. (EDAP) Outlines Key Events Scheduled In The Ablatherm-HIFU PMA Process 5/27/2014
EDAP TMS S.A. (EDAP)'s Ablatherm-HIFU FDA Panel Meeting Confirmed For July 30, 2014 5/22/2014
EnviroLogix Release: DNAble For Salmonella Receives AOAC Certification 5/20/2014
MediWound (MDWD) Announces Successful GMP Manufacturing Audit By The Israeli Ministry Of Health 5/20/2014
Victory For Given Imaging Ltd. (GIVN) As The FDA Downgrades Risk Classification For Pill Camera 5/19/2014
Feds Investigate St. Jude Medical (STJ) For Potential FCA Violations 5/8/2014