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Medical Dev. & Diag. - Regulatory
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
Would Washington’s FDA Fix Cure Patients Or The Drug Industry? 10/21/2015
Gaumard Scientific's Latest UNI Operating System Is Compliant with Newly Released 2015 AHA CPR/ECC Guidelines 10/19/2015
EDAP TMS S.A. (EDAP) Direct De Novo For Ablatherm HIFU Replaced By 510(K) 10/16/2015
Kapa Biosystems Earns ISO 13485:2003 Certification 10/15/2015
Alere (ALR) Receives U.S. HHS Approval To Electronically Process Drug Tests For Department Of Transportation-Regulated Employees 10/15/2015
Nemaura Medical Announces Filing Of Application For FDA Pre-Submission Program For Sugarbeat System 10/13/2015
Promega Corporation Powerplex Fusion 6C System Receives Approval By The FBI 10/13/2015
Gensignia Receives CLIA Certification Of Its San Diego Laboratory 10/13/2015
TearLab (TEAR) Release: Medical Necessity Of Tear Osmolarity Testing In The Diagnosis And Management Of Dry Eye Disease Confirmed In Recently Published Medicare Local Coverage Determination 10/9/2015
Avant Diagnostics Receives FDAIRB Approval for OvaDx Ovarian Cancer Validation Test Specimens 10/7/2015
FDA Sets New Regulations Affecting Entire AED Market 10/1/2015
Biomerica (BMRA) Working With FDA On Submission For Its IBS Product 9/30/2015
iNeedMD Receives CFDA Registration In China 9/30/2015
Avant Diagnostics Commences Ovadx Ovarian Cancer Test Calibration In Preparation For FDA Submission 9/24/2015
Tactio Health Group Release: TactioRPM Now Registered At The FDA As A Class 1 Medical Device Data System 9/24/2015
Roche (RHHBY) Receives FDA CLIA Waiver For Flu A/B Test For Use On Its Cobas Liat PCR System 9/22/2015
Xhale Inc. Submits Biomarker Qualification Package To FDA For Medication Adherence Monitoring Tool 9/22/2015
FDA Expands Warnings About Contaminated Medical Scopes 9/18/2015
ANSYS, Inc. (ANSS) Certified For The Latest Generation Chip Technology 9/17/2015
IntriCon Corporation (IIN) Secures National Health Service Product Approval 9/17/2015
Bracket Announces EXACT e-Diary Certification On Tablet And Smartphone 9/15/2015
First Patient Enrolled In CeloNova’s e-COBRA Clinical Registry 9/14/2015
Gecko Biomedical Achieves Significant Milestone With ISO 13485:2003 Certification 9/14/2015
Graftys Announces The Extension Of Its CE Mark For Its Calcium Phosphate Cements To Now Include GRAFTYS HBS And GRAFTYS Quickset For The Indication Of Subchondral Bone Marrow Lesions Around The Knee Joint (BML) 9/14/2015
RedHill Biopharma Ltd. (RDHL) And IntelGenx Corp. Announce RIZAPORT (RHB-103) Marketing Authorization Application Is Approvable Under The European Decentralized Procedure 9/10/2015
BioCision, LLC Announces FDA Master File Acceptance For Thawstar Automated Cell Thawing Instrument 9/9/2015
EndoGastric Solutions, Inc. Announces AMA Assignment Of CPT Code And Short Form Descriptor 9/9/2015