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Medical Dev. & Diag. - Regulatory
Nanomix, Inc. Receives ISO 13485:2003 Certification 11/25/2014
IRadimed Corporation Files 510(K) Submission For Premarket Notification 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
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
Great Basin Scientific, Inc. Submits 510(K) Application To FDA For Group B Strep Assay 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
Alliqua Biomedical (ALQA)'s Biovance® Assigned Level II HCPCS Q Code For Product Reimbursement 11/3/2014
NeuroSigma, Inc. Receives Notice Of Allowance From The Mexican Institute Of Industrial Property Covering Subcutaneous Trigeminal Nerve Stimulation (sTNS) 11/3/2014
Abiomed (ABMD) Surges On FDA Deal For Impella Indication 10/31/2014
InspireMD Ltd. Investigational Device Exemption (IDE) Amendment Approved By The FDA 10/30/2014
Chembio Diagnostics, Inc. (CEMI.OB)'s DPP® HIV 1/2 Assay Receives CLIA Waiver From 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
bioMerieux SA Working To Get FDA Approval For Ebola Screening Test 10/21/2014
Ivera Medical Corporation Successfully Completes FDA Inspection 10/21/2014
Cerus Corporation (CERS) Submits Compassionate Use IDE Supplement For INTERCEPT Blood System Treatment Of Ebola Convalescent Plasma 10/20/2014
Otoharmonics Corporation Release: Levo Tinnitus System Receives Health Canada License As A Class 2 Medical Device 10/16/2014
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
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
Can Chocolate Bars With Silver Nanoparticles Cure Ebola? FDA Commissioner Riffs On Fraud 10/8/2014
FDA Doubtful On New Watchman Data From Boston Scientific Corporation (BSX) 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
Helius Medical Technologies Announces Health Canada Approval To Start Investigational Testing For The Pons™ Device 10/2/2014
Alere Inc. (ALR) Release: Entamoeba histolytica Rapid Test Receives CE Mark 10/2/2014
FDA Issues New Guidelines For Medical Devices' Cybersecurity 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
Atossa Genetics, Inc. (ATOS) Provides Regulatory And Commercial Update On Its ForeCYTE Breast Aspirator And Its FullCYTE Breast Aspirator 9/24/2014
Sophia Genetics Receives CE-IVD Mark For Genetic Testing Of Familial Mediterranean Fever And Hypercholeteromia 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
World Health Organization Issues Prequalification Of Becton, Dickinson and Company (BDX) FACSPresto™ Near-Patient CD4 Counter System For HIV/AIDS Monitoring 9/23/2014
GHX Successfully Submits Product Data To The FDA Production Global UDI Database (GUDID) Ahead Of Deadline 9/23/2014
T2 Biosystems (TTOO) Receives FDA Authorization To Market T2Candida And T2Dx For The Detection Of Sepsis-Causing Pathogens 9/23/2014
Neuromod Secures ISO Certification Ahead Of Multisensory Tinnitus Treatment Launch 9/18/2014
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
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
Intertek’s Boxborough, MA Laboratory Receives A2LA Scope Expansion For Mechanical And Environmental Testing 9/8/2014
Boyd Corporation Receives ISO 13485:2003 Quality Certification For Medical Devices 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
FDA Approves Changes To Covidien plc (COV) Recalled Devices 8/21/2014
Exco Intouch Achieves Quality Milestone With Iso9001:2008 Certification 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
IMRIS Receives Health Canada Licensing For Integrating Latest Generation MR Scanners Within VISIUS Surgical Theatre 8/21/2014
Royal Philips Electronics N.V. (PHG) Receives FDA 510(K) Clearance For TAVI Precision Treatment Planning Application 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
CardioMEMS Heart Failure Monitoring System Receives Approval From CMS For New Technology Add-On Payment 8/5/2014
EDAP TMS S.A. (EDAP) Comments On FDA Panel Vote 8/5/2014
FDA Panel In Favor Of Cohera Medical, Inc.'s TissuGlu® Surgical Adhesive 8/4/2014
EDAP TMS S.A. (EDAP) Did Not Provide Enough Evidence That Prostate Cancer Device Is Safe: FDA 8/1/2014
FDA Bans Medtech 510(K) Pathway's "Split Predicates" 8/1/2014
ACLA Expresses Concern With FDA Guidance On Laboratory Developed Tests (LDTs) 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
FDA Rejects Redwood City's AcelRx Pharmaceuticals (ACRX) Painkiller Dispensing Device; Stock Plunges -34.35% At 9:37AM ET 7/29/2014
FDA Staff Questions EDAP TMS S.A. (EDAP)'s Prostate Cancer Device 7/29/2014
SAGE Labs Licenses CRISPR/Cas9 Technology From The Broad Institute 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
Venaxis, Inc. (APPY) Reports On Recent FDA Submission Activities 7/16/2014
bioTheranostics Receives Approval To Perform Breast Cancer Index Testing For Patients In State Of New York 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 FDA Warning Letter For Sylmar Facility 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 2013 FDA Warning Letter 7/2/2014
ReShape Medical Submits PMA Application To FDA For Non-Surgical Weight Loss Device 7/1/2014
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
Signal Genetics LLC (SGNL) Obtains New York State Approval For MyPRS® Multiple Myeloma Prognostic Test 6/30/2014
GE Healthcare Release: CHMP Recommends EU Approval Of VIZAMYL™ (Flutemetamol F18 Injection) For PET Imaging Of Beta Amyloid Plaque 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
Medtronic, Inc. (MDT) Targeted By Hackers, Lost Patient Records 6/24/2014
Smith & Nephew Inc. (SNN) Halts U.S. Renasys™ Sales Amid FDA Snafu 6/24/2014
FDA Panel Mixed On EnteroMedics (ETRM)'s Implanted Weight-Loss Device 6/18/2014
Yet Another Delay For Boston Scientific Corporation (BSX)'s Watchman Device 6/18/2014
ERT’s AM3® Is First Integrated Home Spirometer/eDiary Authorized To Administer Standardized Asthma And COPD Instruments 6/17/2014
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
Eutropics Pharmaceuticals Laboratory Receives CLIA Certification 6/16/2014
Sequenom Inc. (SQNM) Receives U.S. FDA Premarket Clearance 6/16/2014
Dehaier Medical Systems Ltd. (DHRM) Patented Tele-Consultation Management System V1.0 Software Copyright 6/16/2014
FDA Panel OKs C.R. Bard's Lutonix Balloon 6/13/2014
Apple (AAPL) Discussed "Moral Obligation" To Mobile Health In Secret FDA Meeting 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
NeuroMetrix, Inc. (NURO) Submits Regulatory Application For NC-stat DPNCheck In China 6/10/2014
Pulsar Vascular Receives FDA IDE Approval For The Pulserider® Aneurysm Neck Reconstruction Device For The Treatment Of Intracranial Bifurcation Aneurysms 6/10/2014
Medline Industries, Inc. Will Reopen H&P/Triad Plant That Was Closed After Contamination Woes 6/6/2014
Polyzen Expands Cleanroom Film Operations For Regulated Medical Devices 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
Cothera Receives ISO 13485 Certification 5/29/2014
China Fines Johnson & Johnson (JNJ) And Others For Price Fixing 5/29/2014
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
Emerging Medical Device Firm Advanced Cooling Therapy Receives License For Commercial Sale Of Its Novel Esophageal Cooling Device In Canada 5/28/2014
BioTime (BTX) Receives ISO 13485 Certification For Medical Devices 5/28/2014
TrovaGene, Inc.'s Precision Cancer Monitoring Technology Referenced In Multi-Disciplinary Clinical Consensus Guidelines 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
MediWound (MDWD) Announces Successful GMP Manufacturing Audit By The Israeli Ministry Of Health 5/20/2014
EnviroLogix Release: DNAble For Salmonella Receives AOAC Certification 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
Ariosa Diagnostics, Inc. Receives Conditional Approval From New York State Department Of Health For Harmony™ Prenatal Test In All Pregnant Women 5/6/2014
HeartWare (HTWR) Issues Voluntary Device Correction For HeartWare® Batteries 5/1/2014
Daxor Corporation (DXR)'s Idant Laboratories Subsidiary Earns American Association Of Blood Banks (AABB) Accreditation Again 5/1/2014
FDA Flags Teleflex Incorporated (TFX) For Repeat Violations At Illinois Plant 4/30/2014
Health Canada's Medical Device Bureau Completes Evaluation Of Solos Endoscopy, Inc. (SLSE.PK)'s Endoscopic Instruments For Canada 4/30/2014
Dehaier Medical Systems Ltd. (DHRM) Obtained Authorization From Olympus Corporation (OCPNF) 4/30/2014
Amid Public Uproar, FDA Mulls Risk Upgrade For Controversial Pelvic Mesh 4/30/2014
Bruker Daltonics Inc. Announces Another U.S. Regulatory Milestone 4/24/2014
New FDA Rules May Speed Up Access For Some Medical Devices 4/23/2014
EDAP TMS S.A. (EDAP) Announces Reimbursement Of HIFU Treatment For Prostate Cancer By France's Ministry Of Health 4/21/2014
Philips Healthcare Voluntarily Suspends Manufacturing At An Ohio Facility 4/18/2014
Boston Heart Diagnostics (Formerly Known As Boston Heart Lab) Granted New York Laboratory Permit For Diagnostic Testing 4/17/2014
Dehaier Medical Systems Ltd. (DHRM) Acquired Multiple International Players' Authorization For Chinese Government Procurement 4/16/2014
Almac Diagnostics Receives New York State Laboratory Permit For Trial Enrichment And Companion Diagnostics Development 4/15/2014
Reverse Medical Corporation Announces FDA IDE Approval For The BARREL® Vascular Reconstruction Device For The Treatment Of Intracranial Bifurcation Aneurysms 4/15/2014
BrainScope Company, Inc. Receives ISO 13485 Certification 4/14/2014
FzioMed Inc. Announces Date For Medical Device Dispute Resolution Panel On Oxiplex® 4/11/2014
FDA Allows 23andMe, Inc. Ancestry Testing, Company Still Not Offering Health Reports 4/9/2014
MolecularMD Receives CLIA Certification For Its Second Next Generation Sequencing Laboratory 4/7/2014
Cerus Corporation (CERS) Submits The Medical Device License Application To Health Canada For INTERCEPT Plasma 4/7/2014
Symmetry Medical Inc. (SMA)'s Sheffield, UK Manufacturing Plant Returns To Full Operational Activity 3/26/2014
DermTech International Releases Validation Data And Announces CLIA Licensure 3/24/2014
Samsung Corporation S5 Not A Medical Device, Bypasses Korean Regulation 3/21/2014
Carl Zeiss Receives ISO 9001 Quality Management System Certification 3/21/2014
CFDA Ups Scrutiny Of Medical Devices To Promote Safety 3/20/2014
Fio's Deki Reader Meets Field Evaluation Objective For Automated Interpretation Of Rapid Diagnostic Tests For Multiple Disease Strains 3/20/2014
Cartagenia n.v. Receives Canadian Medical Establishment License 3/18/2014
NeuroMetrix, Inc. (NURO) Submits Regulatory Application For NC-stat DPNCheck In Japan 3/12/2014
AngioDynamics (ANGO) Updates U.S. Tip Location Strategy 3/7/2014
MolecularHealth Receives CLIA Certification For Clinical Lab 3/3/2014
Roka Bioscience, Inc. Awarded AOAC-RI Certification For Atlas® STEC EG2 Combo Detection Assay 2/28/2014
Connecticut Spring & Stamping Receives ISO 13485 Medical Certification For Quality Management 2/27/2014
Carl Zeiss Receives ISO 9001 Quality Management System Certification 2/24/2014
BioElectronics Corporation Applauds FDA Recommendation to Reclassify Shortwave Medical Devices To Class II 2/21/2014
FDA Sets A Date To Review XVIVO's Lung Perfusion System 2/17/2014
AOAC Certifies InstantLabs E. coli O157 Test Kit 2/13/2014
Invisible Sentinel Wins Certification For Its Listeria Species Assay 2/10/2014
Chembio Diagnostics, Inc. (CEMI.OB) Provides Update On DPP® HIV 1/2 Assay CLIA Waiver Application 2/10/2014
BSD Medical (BSDM) Announces Taiwan Food And Drug Administration Marketing And Import License Approval For The BSD-2000 Is In Process 2/7/2014
Thermo Fisher Scientific (TMO) Release: Mercury Monitoring System Enhancements Designed To Assist Users With Meeting EPA Standards 2/5/2014
Bodkin Design & Engineering, LLC Receives Certification Of Compliance By TUV Rheinland Of North America For The Manufacture Of Electronic Medical Devices 2/5/2014
Consensys Imaging Service, Inc. Receives Certification To ISO 9001:2008 And ISO 13485:2003 Quality Standards 2/5/2014
Solos Endoscopy, Inc. (SLSE.PK) Receives ISO 13485:2003 Certification From TUV SUD America 1/28/2014
Apple (AAPL) Hires Medtech Talent In Pursuit Of iWatch Wow Factor 1/24/2014
Carl Zeiss Release: Axio Scan.Z1 Digital Slide Scanner Acheives Optimal Image Quality 1/22/2014
AMxTek Announces USPTO "Notice Of Allowance": Methods Of Using Water-Soluble Inorganic Compounds For Implants 1/20/2014
Smithers Pira Lansing Laboratory Achieves Key Accreditation For Medical Device And Pharmaceutical Product Testing 1/14/2014
EndoChoice Announces Health Canada License For Fuse Endoscopy System In Canada 1/14/2014
The Journal Of Medical Device Regulation Has A New Look 1/14/2014
Covert Google Inc. X Staffers Meet With FDA On Devices 1/13/2014
Molecularhealth Registers For Medical Device Accreditation In Germany 1/13/2014
Freedom Meditech, Inc. Announces Class I European Compliance And Canadian License For The Clearpath DS-120™ Lens Biomicroscope 1/10/2014
EKF diagnostic GmbH’s Quo-Lab Hba1c Analyzer Secures IFCC Certification 1/9/2014
ARCA biopharma Announces FDA Acceptance Of Gencaro Companion Diagnostic Test IDE 1/8/2014
Hospira, Inc. (HSP) In Hot Water As FDA Formally Slaps Indian Plant With Warning 12/27/2013
Atossa Genetics, Inc. (ATOS) Submits Premarket 510(k) Notification For ForeCYTE Breast Aspirator 12/27/2013
Natera Receives New York State Laboratory Permit For Its Portfolio Of Next-Generation Preconception And Prenatal Genetic Tests 12/23/2013
Invacare Corporation (IVC) Provides Update On Third Certification Report Relating To FDA Consent Decree 12/23/2013
Uroplasty, Inc. (UPI) Announces Positive Coverage Decision For Percutaneous Tibial Nerve Stimulation By Medical Mutual 12/23/2013
Endologix Inc. Receives IDE Approval For The Nellix® Endovascular Aneurysm Sealing System 12/20/2013
Medtronic, Inc. (MDT) Exec Gives Insight On How To Improve Medical Device Safety 12/18/2013
Paragonix Technologies Inc. Makes FDA Bid For Sherpa Kidney, Heart Transportation Systems 12/18/2013
Getinge Release: Medical Systems Business Area Enhancing Its Manufacturing Quality Systems Following U.S. FDA Inspections 12/18/2013
FDA Launches Program That Allows Medtech Cos To Voluntarily Report Violations, Avoid Inspections 12/13/2013
Boston Scientific Corporation (BSX) May Face A Tough FDA Panel 12/11/2013
ARCA biopharma Announces IDE Submission To FDA For Gencaro Companion Diagnostic Test 12/5/2013
Genetic Test Maker 23andMe, Inc. Stops Marketing After FDA Warning 12/3/2013
InControl Medical LLC Pelvic Floor Muscle Stimulators Receive Class 2 Medical License For Sale In Canada 12/2/2013
Chembio Diagnostics, Inc. (CEMI.OB) Files For CLIA Waiver With FDA For Point-Of-Care DPP(R) HIV 1/2 Assay 12/2/2013
Bedfont Scientific NObreath® Listed In National Institute for Clinical Excellence (NICE) Guidelines For FeNO Testing 11/26/2013
FDA Tells Google Inc.-Backed 23andMe, Inc. To Halt DNA Test Service 11/25/2013
Hematogenix Laboratory Services LLC - The First Diagnostic Testing And CLIA-Certified Biomarker Services Laboratory To Offer Advanced Cell Diagnostics, Inc., RNAscope® Assays To Clients 11/25/2013
Bio-Imaging Research Achieves ISO 9001 Registration From The British Assessment Bureau 11/22/2013
Somna Therapeutics Announces Submission To FDA For A Novel New Medical Device To Treat Symptoms Of Acid Reflux Into The Throat And Lungs 11/20/2013
SFL Managing Director Provides Further Update Regarding Revision Of EU Medtech Legislation 11/18/2013
MicroTest Laboratories Release: Current Regulatory Expectations Affecting The Validation Of Reusable Medical Devices Is Subject Of Dec. 4th Seminar In Boston 11/13/2013



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