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Medical Dev. & Diag. - Regulatory
Myriad Genetics (MYGN) Release: Endopredict Receives Positive Coverage Decisions From Medicare And Anthem 8/18/2017
Approval of Medical Device Changes Often Based On Low-Quality Research, UCSF and Yale University School Of Medicine Study 8/17/2017
Valeant (VRX)'s Tampa Facility on Track With Getting Clean Bill of Health From the FDA 8/17/2017
ACF Bioservices Completes cGMP-Compliant Testing Facility For Gene And Cell Therapy Products 8/17/2017
TrovaGene (TROV)'s PLK1 Inhibitor PCM-075, In Preclinical AML Data, Significantly Enhances The Efficacy Of A FLT3 Inhibitor In Combination Therapy 8/16/2017
Defeating Cyberattacks On 3D Printers, Rutgers University Reveals 8/16/2017
ivWatch Achieves ISO 13485 Certification: Provides Foundation For International Distribution 8/15/2017
Dubai Health Authority Implements Masimo (MASI) Patient SafetyNet 8/14/2017
Malware Hidden In Synthetic DNA Could Infect Sequencing Systems 8/11/2017
AdvaMed Goes Social With Anti-Medtech Tax Ad 8/10/2017
Establishment Labs Announces Leadership For Energy And Environmental Design (LEED) Gold Certification On Its Headquarters In Costa Rica 8/10/2017
The ApiFix Spinal Implant Receives TGA Certification 8/8/2017
Siemens (SI) to Update PET Scanner Systems in Light of Cybersecurity Vulnerability 8/8/2017
FDA Issues Emergency Use Authorization for Thermo Fisher Scientific (TMO)'s Zika Virus Assay 8/4/2017
The CE Mark Matters In Medical Markets 8/1/2017
CogState Ltd (CGS.AX) Receives Positive FDA Notification Regarding Medical Device Regulatory Submission 7/27/2017
Medtronic (MDT) First To Receive Health Canada Licence For MR-Conditional Cardiac Resynchronization Therapy-Defibrillators 7/26/2017
Health Canada Release: Advisory - Important Safety Information For People With Diabetes Using NovoPen Echo Or NovoPen 5 7/26/2017
Safety Of Medical Devices Not Often Evaluated By Sex, Age, Or Race, Yale Study Reveals 7/25/2017
Small Details, Big Difference: New White Paper From Mettler-Toledo (MTD) Details Safe Weighing In 3 Steps 7/24/2017
OraSure Tech (OSUR) Receives World Health Organization Prequalification Of OraQuick HIV Self-Test 7/21/2017
TearLab (TEAR) Announces European Regulatory Clearance For Next-Generation Tearlab Discovery System 7/21/2017
KD&A Release: Meeting Medical Software Regulatory Requirements 7/21/2017
Managing Hackers and the Ongoing Healthcare Cybersecurity Crisis 7/20/2017
Is The FDA Biotech's Best Friend? 7/20/2017
EDAP TMS (EDAP) Withdraws 510(k) Application for Focal One 7/18/2017
Guided Therapeutics Re-Establishes Communications With U.S. FDA And Discusses Plan For Refiling For Approval Of The Luviva Advanced Cervical Scan 7/18/2017
FDA's 60-Day Extension For Medical Device Defects Not Likely Obstructive To Public Health 7/17/2017
EKF diagnostic GmbH Publishes "Diabetes And Hba1c Testing" Guide 7/17/2017
FDA Deal Would Relax Rules On Reporting Medical Device Problems 7/14/2017
FDA Spurns Ocular Therapeutix (OCUL)'s Eye Drug Again Despite Eleventh Hour Scramble 7/12/2017
Agendia BV’s Mammaprint Recommended By ASCO Breast Cancer Guideline In Focused Update Based On Landmark MINDACT Trial Data 7/11/2017
Roka Bioscience (ROKA) Announces AOAC Certification For 18-Hour Sample Enrichment Using ActeroTM ELITE Listeria Enrichment Media And The Atlas Listeria Environmental Assay 7/11/2017
Innovation In Quality Assurance: New Sysmex America BeyondCareSM Quality Monitor 7/11/2017
Promega Corporation Intends To Seek FDA Approval For Microsatellite Instability Assay To Assist In Strategic Cancer Decisions 7/6/2017
Agendia BV's MammaPrint Recommended By The 2017 St. Gallen International Breast Cancer Guidelines In Significant Update 7/6/2017
Update On Biotricity 510(k) Filing 7/5/2017
MannKind (MNKD) Receives Accreditation From College Of American Pathologists 6/29/2017
Custom Ultrasonics Receives Resumption Of Manufacturing Letter From FDA 6/27/2017
Impact Cryotherapy Commits to European Markets With CE Certification 6/27/2017
Aspire Bariatrics Announces Aspireassist Receives Australian TGA Approval And First Commercial Cases Performed In Australia 6/22/2017
Nuvectra (NVTR) Files Regulatory Submission With FDA For Algovita MRI-Conditional Approval 6/21/2017
AMSilk’s Quality Management Receives Certification According To The International Medical Devices Standard DIN EN ISO 13485:2016 6/21/2017
Medizone Release: AsepticSure Receives Full Approval Of International Electrical Safety Standards 6/21/2017
FUJIFILM Medical Systems USA, Inc.’s Synapse PACS Is First System Granted Authority To Operate Under New U.S. Dod Process 6/20/2017
Biotricity Receives Ethics Approval To Investigate Mobile Wireless Fetal Monitoring 6/20/2017
New FDA Head Lays Out Bold Plan for Digital Health Regulation 6/16/2017
Claritas Genomics Receives New York State (NYS) Approval For Bone Marrow Failure, HLH/MAS, Nephrotic Syndrome, And Mitochondrial DNA Tests 6/14/2017
Zimmer Biomet Announces Resolution Of FDA Warning Letter Related To Its Zhejiang, China Manufacturing Facility 6/13/2017
Vertera Spine Receives New CMS ICD-10 Code For Radiolucent Porous Interbody Fusion Devices 6/13/2017
HeartFlow Announces Its Novel, Non-Invasive Ffrct Technology For Coronary Artery Disease Receives Positive Review From Blue Cross Blue Shield 6/12/2017
Medovex Corporation Receives ISO 13485 Certification For The DenerveX System 6/7/2017
3M Company (MMM) Tegaderm CHG I.V. Securement Dressing Receives FDA 510(K) Clearance For Expanded Indication To Reduce Catheter-Related Bloodstream Infection 6/6/2017
Dextera Surgical Inc. (DXTR) Files 510(K) For Microcutter 5/80 Expanded Indications 6/1/2017
Maetrics Release: Practical Checklist Of Changes To Comply With New Medical Device Regulation (MDR) Requirements Now Available 6/1/2017
Mylan (MYL) Accused of Overcharging the Government by About $1.27 Billion for EpiPens 6/1/2017
Ortho-Aci Included On The Australian Register Of Therapeutic Goods 5/31/2017
Applied BioCode, Inc. Achieves A Significant Milestone With ISO 13485:2003 Certification 5/30/2017
Kinpo Electronics Acquired EU Medical Certificate For Wearable ECG Monitor - BC1 Patch 5/30/2017
ArcticDx Inc. Release: Vita Risk Test Receives U.S. Medicare Approval 5/30/2017
What Should Trigger A CAPA In Medical Device Manufacturing? 5/25/2017
Mesa Biotech Receives ISO 13485 Quality Certification 5/23/2017
Avacen Medical Release: New Concept For Treating Pain Approved By Health Canada 5/23/2017
NPPA Asks Medtechs To Submit Data Of All 19 Devices Notified As Drugs On Prescribed Format To Prevent Overcharging 5/23/2017
EDAP TMS (EDAP) Announces CMS Approval Of New Reimbursement Code For HIFU Ablation Of The Prostate 5/22/2017
Bay Area's Intersect ENT Gets a PDUFA Date From the FDA for Steroid Releasing Sinus Implant 5/22/2017
Cogmedix Successfully Passes ISO 13485:2016 Recertification Audit 5/19/2017
co.don AG (DX:CNW): Positive Opinion From CHMP For EU Approval Of Articular Cartilage Product 5/18/2017
FDA Throws a Roadblock at Globus Medical (GMED)’s ExcelsiusGPS Robot-Assisted Surgery Platform 5/18/2017
Life Spine, Emerge Diagnostics, Institutional Review Board To Conduct A Study Utilizing Electrodiagnostic Functional Assessment (EFA) 5/17/2017
Correcting Misconceptions About FDA Design Controls For The Medical Device Industry 5/15/2017
The ‘Gravity Blanket’ Raised $3 Million Online With A Claim To Treat Anxiety. Then That Promise Was Deleted 5/12/2017
CETECOM Tests According To The EMC Standard Iec 60601-1-2 (4th Edition) For Medical Electrical Devices 5/12/2017
Medrobotics Announces TGA Clearance For Flex Robotic System For Scarfree Colorectal Procedures 5/11/2017
Avita Medical Release: Initial Pre-Emergency Use Authorization Submission Made To U.S. FDA For Use Of ReCell In A Mass Casualty Scenario 5/10/2017
Contextual Genomics Receives DAP Accreditation For Testing And Informatics System 5/10/2017
Fast-Growing Intarcia Awaits Crucial FDA Decision in New Boston HQ 5/8/2017
Oventus Release: FDA Submission Lodged For O2Vent W 5/5/2017
Baxter International (BAX) Achieves Regulatory Milestone For New Peritoneal Dialysis Technology 5/3/2017
Modern Strategies To Mitigate Risk In Medical Device Development 5/1/2017
A Heart-To-Heart From The Hackers: Cyber-Vulnerabilities In Cardiac Devices 4/27/2017
Abbott (ABT), Medtronic (MDT) Can't Pull Stents Out, Says Indian Regulator 4/27/2017
Foresight Medical Completes SOC 2 Type 2 Data Security Examination 4/26/2017
Amedica Announces Regulatory Clearance To Market And Sell Valeo Silicon Nitride Spinal Implants In Australia 4/25/2017
ALung Submits IDE Application To FDA Seeking Approval To Conduct Pivotal Study Of The Hemolung RAS 4/25/2017
Portal Instruments Receives ISO 13485:2012 Certification From NSAI 4/24/2017
Abbott (ABT)'s St. Jude Medical (STJ) Unit Hit with FDA Warning Letter on Fortify, Unify, Assura Defibrillators 4/13/2017
NEO Tech Adds ISO 13485 Medical Certification At Its Chatsworth, CA Location 4/12/2017
Kimberly-Clark Corporation (KMB) To Challenge Verdict In Microcool Class Action Lawsuit 4/10/2017
FDA Finally Allows 23andMe to Sell At-Home DNA Tests for 10 Diseases 4/10/2017
Avita Medical Release: FDA Approves Increased Compassionate Use Patient Cases And Sites For Recell In Life-Threatening Injuries 4/7/2017
Intralytix Receives FDA Regulatory Clearance For Phage-Based Shigella Technology 4/7/2017
Collagen-Targeting PET Probe May Improve Pulmonary Fibrosis Diagnosis And Treatment, Massachusetts General Hospital Reveals 4/6/2017
Rainin’s Pipette Service Puts The Customer First 4/6/2017
PreventionGenetics LLC Receives New York License For Genetic Tests 4/4/2017
Materion Precision Coatings Awarded ISO 13485 Quality Certification 4/4/2017
Neotherma Oncology Announces FDA Granted Its Vectron Thermal Device For Treatment Of Pancreatic Cancer Breakthrough Device Designation Within Expedited Access Pathway 4/4/2017
Novogene NGS Medical Lab Receives CAP Accreditation 4/4/2017
United Therapeutics (UTHR) Announces Regulatory Delays For Remosynch Implantable Pump 4/3/2017
Shocker: Life-Saving Portable Defibrillator Movement Plagued By Malfunctions 3/31/2017
LabCorp (LH) Commends Reps. Dr. Bucshon, DeGette For Releasing Bipartisan Discussion Draft Of The Diagnostic Accuracy And Innovation Act (DAIA) 3/30/2017
Neurotech Files Pre-Submission Package With The U.S. FDA 3/30/2017
Kraig Biocraft Laboratories, Inc. Awarded Investment Certificate In Vietnam 3/27/2017
SeraCare Life Sciences (SRLS) Announces Launch Of Industry's First Multiplexed Inherited Cancer Reference Material 3/24/2017
DexCom (DXCM) Release: Medicare Announces Criteria Covering Dexcom G5 Mobile CGM For All People With Diabetes On Intensive Insulin Therapy 3/24/2017
BBI Solutions & Dr C. Sturgeon Consider International Standards For Cancer Biomarkers 3/24/2017
European Group On Tumour Markers (EGTM) Updated Guidelines Recommend Agendia BV's Mammaprint Test With Highest Level 1A Clinical Evidence 3/22/2017
Steriliz Release: R-D Rapid Disinfector Outperforms Competitive UV-C Disinfection System In An Independent Study 3/22/2017
InVivo Therapeutics (NVIV) Announces Submission To The FDA Of Its Nonclinical Studies Module For The Neuro-Spinal Scaffold 3/21/2017
NuVasive (NUVA) Release: New Evidence-Based Recommendation Released From NICE (U.K.) For Lateral Interbody Fusion 3/20/2017
With Key Hire, Veritas Genetics Takes Leap Toward Affordable Genome Sequencing 3/17/2017
FDA Proposes Exempting Hundreds of 337 Class II Devices From 510(K) Requirements 3/16/2017
GOP Bill Could Force Employees To Undergo DNA Tests Or Pay Huge Fines 3/15/2017
Pulse Biosciences Submits 510(k) Application To FDA For PulseTx System 3/14/2017
Counsyl Supports New Guidance From American College of Obstetricians and Gynecologist On Expanded Carrier Screening For Prenatal Genetic Testing 3/9/2017
CooperGenomics Receives ISO 15189 Accreditation In United Kingdom Laboratories For Noninvasive Prenatal Testing 3/8/2017
Alere (ALR) Gets FDA CLIA Waiver for Alere i RSV Rapid Molecular Test 3/7/2017
PolySkope Labs Announces AOAC PTM Submission of the World's First Comprehensive Multiplex Pathogen Detection Method for Food Safety Industry 3/7/2017
5 Tips To Survive An FDA Inspection 3/6/2017
5 Predictions For The Medical Device Industry 3/6/2017
American College of Radiology: Medic Vision Safect-29 Is The Only FDA & CMS Approved Third-Party Solution For XR-29 Compliance 3/1/2017
President Trump: Keep Your Peter (Thiel) Out Of Our FDA Politics 3/1/2017
BioElectronics Corporation Letter From The President 2/28/2017
Claret Medical Release: FDA Advisory Committee Strongly Supports Granting De Novo Application For The First Cerebral Protection System For Transcatheter Aortic Valve Replacement (TAVR) 2/27/2017
Senators Introduce A Bill To Overhaul Medical Device Inspections 2/24/2017
Is Trump About To Blow Up Medtronic (MDT)'s Tax Avoidance Business Model? 2/24/2017
Accelerate Diagnostics (AXDX) Receives FDA Marketing Authorization For The Accelerate Pheno System And Accelerate PhenoTest BC Kit 2/24/2017
Becton, Dickinson and Company (BDX) Veritor System Meets FDA's New Performance Requirements For Rapid Influenza Antigen Detection Tests 2/22/2017
EchoPixel, Inc. Announces CE Mark Certification For True 3D Viewer 2/22/2017
SeqGen, Inc. Earns ISO 9001:2015 Certification 2/21/2017
Wound Care Technologies Achieves ISO 13485 Certification 2/17/2017
Medovex Corporation Completes Phase II CE Mark Audit With Notified Body LNE/GMED 2/15/2017
Here Is What Donald Trump's Policies May Mean for Medical Equipment Companies 2/14/2017
29K Medtech Jobs Lost Under Medical Device Tax, AdvaMed Says 2/10/2017
Aved Medical Cable Assemblies Feature 100% Testing And Data Records 2/8/2017
Mitra Biotech Obtains CLIA Certification For Flagship Massachusetts Lab 2/7/2017
Canon Virginia, Inc. Announces Receipt of ISO 13485 Certification and the Launch of Medical Device Contract Manufacturing Services 2/7/2017
Second Sight (EYES) Announces Record Date, Subscription Pricing, Expiration Date For Rights Offering And Effectiveness Of Its Registration Statement 2/6/2017
Evonik Industries Release: RESOMER MD Biodegradable Polymers Receive ISO 13485 Certification 2/6/2017
Nuvectra (NVTR) Files Regulatory Submissions For FDA And CE Mark Approvals Of The Virtis Sacral Nerve Stimulation (SNS) System 2/2/2017
Millennium Health Release: New Study Characterizes Detection Of Hydrocodone And Morphine As Metabolites Of Codeine In Oral Fluids 1/30/2017
Medtronic (MDT) Snags CMS Coverage for Micra Leadless Pacer 1/27/2017
Medtronic (MDT) Receives IDE Approval To Initiate Study Of IN.PACT Admiral Drug-Coated Balloon For A New Indication In Patients With End-Stage Renal Disease 1/26/2017
Pulmatrix (PULM) Jumps on News From the FDA 1/18/2017
Exosome Diagnostics Release: Company Obtains ISO 15189 For Its Munich Laboratory 1/18/2017
Braeburn Pharma Release: Company's Probuphine Implant Receives J-Code By Centers for Medicare & Medicaid Services 1/13/2017
SQI Diagnostics Release: Company To Extend Warrant Expiry 1/13/2017
BioCorRx  (BICX) Release: Company Retains Innovative Science Solutions To Guide FDA Regulatory Process For Its Naltrexone Products 1/13/2017
Kraig Biocraft Laboratories, Inc. Release: Company's Management Completes Meetings With Vietnamese Officials 1/12/2017
Boston Scientific (BSX) Finds ‘Fix’ for Lotus Edge Heart Valve, Expects to Submit PMA in May 1/11/2017
Abbott (ABT) Releases Cyber Updates For St. Jude Medical (STJ) Devices After Government Probe 1/10/2017
Medosome Biotech Release: Company Receives Accreditation From College of American Pathologists 1/9/2017
Curetis Files for U.S. FDA Clearance For Unyvero Platform And LRT Application Cartridge 1/9/2017
Health Canada Release: Information Update - New Safety Information On Injectable Gadolinium-Based Contrast Agents Used In MRI Scans 1/9/2017
Vermillion Announces Reimbursement Code Updates For Overa And OVA1 1/9/2017
Vermillion And ASPiRA LABS Announce Receipt Of Formal FDA Clarification Regarding Ovarian Cancer Screening Alert 1/5/2017
California Life Sciences Association Applauds Reintroduction Of Bill To Fully Repeal Medical Device Tax, Spur Medical Innovation 1/4/2017
Alere (ALR) Laboratory Receives ABFT Accreditation 1/4/2017
Medovex Corporation Receives SGS Certification For Its DenerveX System 1/4/2017
Transperfect’s Updated Encompass System Transforms Regulatory Compliance Into Competitive Advantage For Medical Device Manufacturers 1/4/2017
The U.S. Has Issued Outlines For Connected Medical Device Security 12/30/2016
Obama's Gift To The Biotech Industry 12/30/2016
FDA Issues Final Guidelines On Keeping Medical Devices Safe From Cyberattack 12/29/2016
UK-Based Paxman Seeks FDA Clearance For Advanced Scalp Cooling Technology 12/29/2016
MiMedx Announces Preliminary Investigation Findings 12/27/2016
UK Government Announces Funding For Second Sight (EYES)’s Argus II "Bionic Eye" 12/22/2016
GenMark Diagnostics (GNMK) Submits 510(K) Applications To The FDA For ePlex Sample-To-Answer Instrument And Respiratory Pathogen Panel 12/22/2016
Congress Needs To Turn Its Attention To Medical Device Safety 12/21/2016
Trovita Health Science Announces FDA 510(K) Submission Of New, Fully Closed System For Administration Of Tube Feeding Formulas 12/20/2016
Vivex Biomedical Receives Level II HCPCS Q-Code For Cygnus, A Human Amniotic Tissue Allograft 12/20/2016
FDA Expands Indication For Continuous Glucose Monitoring System, First To Replace Fingerstick Testing For Diabetes Treatment Decisions 12/20/2016
Playing By The Rules: Regulatory Requirements For Connected Medical Devices 12/16/2016
MDxHealth, Inc. (MXDHF) Receives ISO 13485:2016 Certification For Dutch Laboratory 12/16/2016
FDA Grants QT Vascular Full IDE Approval To Begin Pivotal Trial Of Its Drug-Coated Balloon, Chocolate Touch 12/16/2016
W. L. Gore & Associates Receives Innovative Technology Designation From Vizient For Gore Synecor Biomaterial 12/15/2016
Biosteel Fibers From AMSilk Receive Certification For Product Safety And Confirmation Of Biological Degradability 12/14/2016
Eclipse Aesthetics Receives ISO 13485:2003 Certification 12/14/2016
Entellus Medical (ENTL) Release: NIH And NICE Provides Positive Guidance For Use Of The Xpress Multi-Sinus Dilation System For Treating Chronic Sinusitis 12/13/2016
SuperSonic Imagine Receives ISO 14001:2015 Certification 12/13/2016
Here’s What VCs And The Medtech Industry Don’t Want You To Know 12/12/2016
The Past, Present And Future Of FDA Regulation Of LDTs 12/12/2016
Should FDA Restrict Our Use Of Our Own Stem Cells? 12/8/2016
Interpace Diagnostics Announces New Aetna Coverage Policy 12/8/2016
LEVL Registers For FDA Class I Medical Device Taking Wellness Community One Breath Closer To Fat-Loss Revolution 12/8/2016
Paradigm Spine, LLC Announces Publication Of ISASS Guidelines Recommending Coverage Of Interlaminar Stabilization 12/6/2016
An Effort To Get Ecstasy FDA-Approved Is Entering A Key Final Test 12/5/2016
CDG Biotech Corporation Is Poised To Enter The Market For Diagnostic Assay Solutions In The Fight Against Allergies And Rare Diseases 12/2/2016
Here's What Some Life Sci Companies Are Saying About Trump 12/1/2016
Cardiac Dimensions Announces Investigational Device Exemption Approval From FDA To Conduct U.S. Pivotal Study Of The Carillon Mitral Contour System For Functional Mitral Regurgitation 12/1/2016
How Apple (AAPL) Has Been Secretly Meeting With The FDA For Years 12/1/2016
New Vetter Data Processing Center Is Officially Certified 11/30/2016
CombiMatrix (CBMX)’s Pre-Implantation Genetic Screening By Next Generation Sequencing Granted Conditional Approval From New York State Department Of Health 11/29/2016
Anuva Manufacturing Services Awarded ISO-13485:2003 Certification 11/29/2016
Neovasc (NVC) Receives Regulatory Approval To Initiate TIARA II CE Mark Study 11/28/2016
Scientific Analysis Laboratories UKAS Accredited For RDF & SRF Testing 11/28/2016
Smith & Nephew Inc. (SNN) Release: New WHO Guidelines Recommend The Use Of NPWT To Help Reduce The Risk Of Surgical Site Infection 11/22/2016
FDA Puts Off Closing Lab-Test "Loophole," Leaving Decision To Congress And Trump 11/21/2016
Medtronic (MDT) CEO Among Corporate Leaders Reaching Out To Workers After Election 11/21/2016
FDA Confirms A 510(K) De Novo Path For EyeGate Pharma’s Device, The Ocular Bandage Gel, Following Pre-Submission Meeting 11/18/2016
Post-Election Commentary From 5 Execs At Major Medtech Firms 11/18/2016