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Medical Dev. & Diag. - Regulatory
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
How Apple (AAPL) Has Been Secretly Meeting With The FDA For Years 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
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
Medtronic (MDT) CEO Among Corporate Leaders Reaching Out To Workers After Election 11/21/2016
FDA Puts Off Closing Lab-Test "Loophole," Leaving Decision To Congress And Trump 11/21/2016
Post-Election Commentary From 5 Execs At Major Medtech Firms 11/18/2016
FDA Confirms A 510(K) De Novo Path For EyeGate Pharma’s Device, The Ocular Bandage Gel, Following Pre-Submission Meeting 11/18/2016
Trump Presidency Could Bode Well For Pharma, Devicemakers 11/14/2016
FDA Spotlights Unapproved Use Of Drugs, Medical Devices 11/14/2016
FDA Completes Transfer Of Emergency Use Authorization For Reebov Ebola Antigen Rapid Test To Zalgen Labs 11/14/2016
Thermo Finnigan Submits Premarket Approval Application To FDA For Universal, Next-Generation Sequencing-Based Oncology Test 11/14/2016
Augmenix Announces New Category 1 CPT Code From The American Medical Association For Periprostatic Implantation Of Biodegradable Material 11/9/2016
Secant Group Launches Regenerez Extruded Component 11/9/2016
Clinton Vs Trump — Who's The Winner For Medtech? 11/8/2016
Myriad Genetics (MYGN) Will Seek Japanese Regulatory Approval For BRACAnalysis CDx 11/7/2016
NeoTract, Inc. Release: UK Government Names Urolift System To Be Fast Track Funded For The NHS As A Strategically Important Product To Improve UK Healthcare 11/7/2016
FDA Granted E-QURE Approval To Initiate Its US Clinical Trial 11/3/2016
CFDA To Start Priority Reviews Of Medical Devices In January 2017 11/3/2016
FDA Clears VITROS Automation Solutions From Ortho Clinical Diagnostics 10/28/2016
Endomag, European Device Makers Eye U.S. Amid Regulatory Changes 10/27/2016
Helius Medical Technologies To Receive ISO 13485 Certificate 10/27/2016
FDA Reclassifies Johnson & Johnson (JNJ) Acclarent's Aera Eustachian Tube Balloon to a Class II Device 10/25/2016
Fujitsu Announces That Renowned MRI Testing Facility, MAGNETIC RESONANCE SAFETY TESTING SERVICES, Confirms That Fujitsu UHF RFID Linen Tags Are Proven Suitable For Use In MRI Systems 10/25/2016
Cepheid (CPHD) Announces Receipt Of Required Regulatory Clearances In Proposed Acquisition 10/24/2016
Orthofix International NV (OFIX) Announces North American Spine Society Coverage Policy Recommendations For Electrical Bone Growth Stimulators 10/24/2016
Which Agency Does The Medical Device Industry Want To Change 10/20/2016
CellMax Life Achieves CLIA Certification & CAP Accreditation For Precision Cancer Testing Laboratories 10/18/2016
Gramercy Extremity Orthopedics Passes Electromagnetic Compatibility Testing 10/18/2016
Advanced Accelerator Applications Announces Positive EMA Opinion On Application For Somakit TOC 10/17/2016
Health Canada Release; Information Update - Premature Battery Depletion With Certain St. Jude Medical (STJ) Implantable Defibrillators 10/17/2016
Avacen Medical Announces Support For New Initiative 10/13/2016
Carestream Health Ultrasound Systems Receive Health Canada License 10/13/2016
Syros Pharma Announces Approval Of Investigational Device Exemption (IDE) For Blood Test To Identify Cancer Patients With Proprietary Biomarkers 10/11/2016
BioStable Science & Engineering Completes Direct De Novo Application To FDA For The HAART 300 Aortic Annuloplasty Device 10/11/2016
BioElectronics Corporation Comments On Its U.S. FDA's OTC Market Clearance Application 10/10/2016
MYnd Analytics California Centers Receive CMS Approval 10/10/2016
Biostage Provides Regulatory Update of Cellspan Esophageal Implant 10/7/2016
Interpace Diagnostics Announces New York State Approval Of ThyGenX For Indeterminate Thyroid Nodules 10/5/2016
Trinity Biotech (TRIB) Cuts Jobs in Shutdown of Swedish Facility, Withdraws Device App With the FDA 10/4/2016
BioDirection Files Pre-Submission Package With FDA 10/4/2016
Heart Test Labs Completes Regulatory Submission For Both FDA 510(K) And CE Mark 10/4/2016
EXACT Sciences (EXAS) Announces Inclusion Of Cologuard In HEDIS Quality Measures 10/4/2016
FDA Grants Valencia Technologies IDE Approval For U.S. Pivotal Study Of Bioelectronic Device For Hypertension 10/3/2016
Serametrix Gains CLIA Certification For MDSC-Based Blood Test For Predicting Response To Immunotherapy In Cancer Patients 9/29/2016
Polaris Debuts Regulatory Monitoring Portal, An Online Resource That Provides Comprehensive Transparency Requirements For Over 40 Countries 9/28/2016
Vela Diagnostics Gets FDA Emergency U.S. Authorization for Zika Test 9/26/2016
Advanced Accelerator Applications Release: EMA Prematurely Announced Opinion On SomaKit TOC Kit Application 9/23/2016
Shuwen Biotech's Clinical Lab Receives Accreditation From College of American Pathologists 9/23/2016
Levita Magnetics Snags Class II Status for Gallbladder Surgery Device 9/22/2016
Claret Medical Submits Marketing Application To FDA For US Clearance Of First Cerebral Protection System For Transcatheter Aortic Valve Replacement (TAVR) 9/20/2016
C. R. Bard, Inc. (BCR) Release: FDA Approves 6-Month Primary End Point For The Lutonix Below-the-Knee Drug Coated Balloon 9/20/2016
New Study Reports Spring Loaded Technology's Bionic Knee Brace Reduces Fatigue And Enhances Performance 9/20/2016
Enzo Biochem (ENZ) Announces New York State Health Department Approval Of New Easily Adaptable, Cost Effective Cardiac Assay 9/20/2016
Humana, Inc. (HUM) CEO: We Are Using Retail Consumer Behavior Analytics To Personalize Care 9/19/2016
Neogen Corporation (NEOG)'s AccuPoint Advanced Receives AOAC Approval 9/19/2016
Lannett (LCI) Announces Successful FDA Inspections Of Three Facilities 9/19/2016
Navidea (NAVB)’s Lymphoseek Receives Positive Opinion In Europe For A New Reduced Mass Vial 9/16/2016
Advanced Accelerator Applications Announces Positive EMA Opinion On Application For Somakit TOC Kit For Radiopharmaceutical Preparation Of Gallium (Ga 68) Edotreotide For Gastroenteropancreatic Neuroendocrine Tumor Detection 9/16/2016
Acclarent: FDA Permits Marketing Of Balloon Device To Treat Persistent Eustachian Tube Dysfunction 9/16/2016
MiMedx Urges FDA To Reconsider Draft Guidances During Hearing 9/15/2016
The Candidates' Views On America's Top 20 Science, Engineering, Tech, Health & Environmental Issues In 2016 9/14/2016
Nanobiotix Announces Submission For First Market Approval Of Lead Product NBTXR3 In Europe 9/14/2016
What's Behind FDA's Warning Against Ovarian Cancer Screening Tests? 9/13/2016
Organogenesis Release: Nation's Leading Developer Of Advanced Wound Care Technologies Urges FDA To Finalize Regulatory Guidance To Ensure Safety And Efficacy Of Section 361 HCT/Ps 9/13/2016
The Theranos Debacle: Why We Should Have Less Regulation Of Everything, Not More 9/12/2016
FDA Expands Emergency Use Authorization For Hologic (HOLX)'s Aptima Zika Virus Assay To Include Use With Urine Samples 9/9/2016
Quotient Limited (QTNTU) Announces Successful Validation Of The Initial Manufacturing System For Mosaiq Microarrays 9/9/2016
QIAGEN N.V. (QGEN) Welcomes U.S. Guidance For Latent TB Testing In Primary Care 9/9/2016
New ESC Guidelines Support Recent Medtronic (MDT) Innovations For Patients With Atrial Fibrillation 9/9/2016
Apple (AAPL) Raises Explicit Guidelines for Mobile Medical and Health App Developers 9/8/2016
Thermo Fisher Scientific (TMO) Pledges To Verify Specificity Of Antibodies In Accordance With New Antibody Validation Recommendations 9/6/2016
Aerotel Medical Systems's HeartLine ECG Monitors Win Colombian INVIMA Certification 9/6/2016
More Trouble for Theranos as FDA Discovers Company Cut Corners With Zika Test 9/1/2016
Another Reason Why Medical Device Class Actions Don’t Work 8/31/2016
FDA Issues Emergency Use of Roche (RHHBY)'s Zika Test 8/29/2016
First Epigenetic Test To Diagnose Tumors Of Unknown Origin, IDIBELL-Bellvitge Biomedical Research Institute Study 8/29/2016
Cerus (CERS) Release: FDA's New Recommendation For Universal Zika Risk Reduction Of Blood Components Includes Use Of Pathogen Reduction 8/29/2016
Embattled Theranos Plans to Appeal to Re-Open Its Lab in Newark, California 8/26/2016
Bioness Inc. Vector Gait And Safety System Receives Expanded UL Certification 8/25/2016
Drugmakers And Medtechs Pay Thousands Of Docs With Disciplinary Records 8/24/2016
10 Disruptive Technologies And The Regulatory Implications 8/24/2016
FDA Allows Marketing Of First-Of-Kind Computerized Cognitive Tests To Help Assess Cognitive Skills After A Head Injury 8/23/2016
Edwards Lifesciences Corporation (EW) SAPIEN 3 Transcatheter Heart Valve Receives Expanded Indication From FDA 8/19/2016
Shuwen Biotech Release: Chinese FDA Grants MammaTyper Innovative Product Status For Expedited Approval 8/19/2016
Cancer Genetics (CGIX) Strengthens Position As A Leader In Myeloid Cancer Diagnosis And Management Receiving New York State Approval For Focus: Myeloid, A Targeted NGS Panel For Improved Diagnosis, Risk Stratification, And Therapy Selection Of Patients With Myeloid Cancers 8/17/2016
Agena Biosciences Expands ISO Accreditation For Genetic Testing 8/16/2016
NovaBone Products Receives GMP Medical Device Certificate 8/16/2016
EXACT Sciences (EXAS) Release: Cologuard Coverage Expands With Updated Policies From HCSC And Florida Blue 8/11/2016
Magellan Diagnostics Receives CFDA Clearance For LeadCare II In China 8/10/2016
ArcherDX NGS Assays Receive Conditional Approval By New York State 8/9/2016
Luminex (LMNX) Receives FDA Emergency Use Authorization For Zika Virus Molecular Detection Assay 8/8/2016
Bracco Diagnostics Release: Virtual Colonoscopy Receives Highest Grade In The New U.S. Preventive Services Task Force Recommendation For Colorectal Cancer Screening 8/5/2016
REVA Medical Release: Submission Of CE Mark Application 8/3/2016
bioMerieux Submits 510(K) Application To The bioMerieux For BacT/ALERT VIRTUO Next Generation Automated Blood Culture System 8/3/2016
pSivida (PSDV) And Hospital For Special Surgery Innovation Center Announce Opening Of IND For Sustained-Release Implant For Severe Knee Osteoarthritis 8/2/2016
Roche (RHHBY) Receives CLIA Waiver For Cobas Influenza A/B & RSV Test For The Cobas Liat 8/1/2016
SGS Academy Release: New ISO 13485:2016 Medical Devices Training Course 8/1/2016
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