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Medical Dev. & Diag. - Regulatory
Philips Healthcare Voluntarily Suspends Manufacturing At An Ohio Facility 4/18/2014  More...
Boston Heart Diagnostics (Formerly Known As Boston Heart Lab) Granted New York Laboratory Permit For Diagnostic Testing 4/17/2014  More...
Dehaier Medical Systems Ltd. (DHRM) Acquired Multiple International Players' Authorization For Chinese Government Procurement 4/16/2014  More...
Reverse Medical Corporation Announces FDA IDE Approval For The BARREL® Vascular Reconstruction Device For The Treatment Of Intracranial Bifurcation Aneurysms 4/15/2014  More...
Almac Diagnostics Receives New York State Laboratory Permit For Trial Enrichment And Companion Diagnostics Development 4/15/2014  More...
BrainScope Company, Inc. Receives ISO 13485 Certification 4/14/2014  More...
FzioMed Inc. Announces Date For Medical Device Dispute Resolution Panel On Oxiplex® 4/11/2014  More...
FDA Allows 23andMe, Inc. Ancestry Testing, Company Still Not Offering Health Reports 4/9/2014  More...
Cerus Corporation (CERS) Submits The Medical Device License Application To Health Canada For INTERCEPT Plasma 4/7/2014  More...
MolecularMD Receives CLIA Certification For Its Second Next Generation Sequencing Laboratory 4/7/2014  More...
Symmetry Medical Inc. (SMA)'s Sheffield, UK Manufacturing Plant Returns To Full Operational Activity 3/26/2014  More...
DermTech International Releases Validation Data And Announces CLIA Licensure 3/24/2014  More...
Samsung Corporation S5 Not A Medical Device, Bypasses Korean Regulation 3/21/2014  More...
Carl Zeiss Receives ISO 9001 Quality Management System Certification 3/21/2014  More...
Fio's Deki Reader Meets Field Evaluation Objective For Automated Interpretation Of Rapid Diagnostic Tests For Multiple Disease Strains 3/20/2014  More...
CFDA Ups Scrutiny Of Medical Devices To Promote Safety 3/20/2014  More...
Cartagenia n.v. Receives Canadian Medical Establishment License 3/18/2014  More...
NeuroMetrix, Inc. (NURO) Submits Regulatory Application For NC-stat DPNCheck In Japan 3/12/2014  More...
AngioDynamics (ANGO) Updates U.S. Tip Location Strategy 3/7/2014  More...
MolecularHealth Receives CLIA Certification For Clinical Lab 3/3/2014  More...
Roka Bioscience, Inc. Awarded AOAC-RI Certification For Atlas® STEC EG2 Combo Detection Assay 2/28/2014  More...
Connecticut Spring & Stamping Receives ISO 13485 Medical Certification For Quality Management 2/27/2014  More...
Carl Zeiss Receives ISO 9001 Quality Management System Certification 2/24/2014  More...
BioElectronics Corporation Applauds FDA Recommendation to Reclassify Shortwave Medical Devices To Class II 2/21/2014  More...
FDA Sets A Date To Review XVIVO's Lung Perfusion System 2/17/2014  More...
AOAC Certifies InstantLabs E. coli O157 Test Kit 2/13/2014  More...
Chembio Diagnostics, Inc. (CEMI.OB) Provides Update On DPP® HIV 1/2 Assay CLIA Waiver Application 2/10/2014  More...
Invisible Sentinel Wins Certification For Its Listeria Species Assay 2/10/2014  More...
BSD Medical (BSDM) Announces Taiwan Food And Drug Administration Marketing And Import License Approval For The BSD-2000 Is In Process 2/7/2014  More...
Consensys Imaging Service, Inc. Receives Certification To ISO 9001:2008 And ISO 13485:2003 Quality Standards 2/5/2014  More...
Bodkin Design & Engineering, LLC Receives Certification Of Compliance By TUV Rheinland Of North America For The Manufacture Of Electronic Medical Devices 2/5/2014  More...
Thermo Fisher Scientific (TMO) Release: Mercury Monitoring System Enhancements Designed To Assist Users With Meeting EPA Standards 2/5/2014  More...
Solos Endoscopy, Inc. (SLSE.PK) Receives ISO 13485:2003 Certification From TUV SUD America 1/28/2014  More...
Apple (AAPL) Hires Medtech Talent In Pursuit Of iWatch Wow Factor 1/24/2014  More...
Carl Zeiss Release: Axio Scan.Z1 Digital Slide Scanner Acheives Optimal Image Quality 1/22/2014  More...
AMxTek Announces USPTO "Notice Of Allowance": Methods Of Using Water-Soluble Inorganic Compounds For Implants 1/20/2014  More...
The Journal Of Medical Device Regulation Has A New Look 1/14/2014  More...
EndoChoice Announces Health Canada License For Fuse Endoscopy System In Canada 1/14/2014  More...
Smithers Pira Lansing Laboratory Achieves Key Accreditation For Medical Device And Pharmaceutical Product Testing 1/14/2014  More...
Molecularhealth Registers For Medical Device Accreditation In Germany 1/13/2014  More...
Covert Google Inc. X Staffers Meet With FDA On Devices 1/13/2014  More...
Freedom Meditech, Inc. Announces Class I European Compliance And Canadian License For The Clearpath DS-120™ Lens Biomicroscope 1/10/2014  More...
EKF diagnostic GmbH’s Quo-Lab Hba1c Analyzer Secures IFCC Certification 1/9/2014  More...
ARCA biopharma Announces FDA Acceptance Of Gencaro Companion Diagnostic Test IDE 1/8/2014  More...
Atossa Genetics, Inc. (ATOS) Submits Premarket 510(k) Notification For ForeCYTE Breast Aspirator 12/27/2013  More...
Hospira, Inc. (HSP) In Hot Water As FDA Formally Slaps Indian Plant With Warning 12/27/2013  More...
Uroplasty, Inc. (UPI) Announces Positive Coverage Decision For Percutaneous Tibial Nerve Stimulation By Medical Mutual 12/23/2013  More...
Invacare Corporation (IVC) Provides Update On Third Certification Report Relating To FDA Consent Decree 12/23/2013  More...
Natera Receives New York State Laboratory Permit For Its Portfolio Of Next-Generation Preconception And Prenatal Genetic Tests 12/23/2013  More...
Endologix Inc. Receives IDE Approval For The Nellix® Endovascular Aneurysm Sealing System 12/20/2013  More...
Getinge Release: Medical Systems Business Area Enhancing Its Manufacturing Quality Systems Following U.S. FDA Inspections 12/18/2013  More...
Paragonix Technologies Inc. Makes FDA Bid For Sherpa Kidney, Heart Transportation Systems 12/18/2013  More...
Medtronic, Inc. (MDT) Exec Gives Insight On How To Improve Medical Device Safety 12/18/2013  More...
FDA Launches Program That Allows Medtech Cos To Voluntarily Report Violations, Avoid Inspections 12/13/2013  More...
Boston Scientific Corporation (BSX) May Face A Tough FDA Panel 12/11/2013  More...
ARCA biopharma Announces IDE Submission To FDA For Gencaro Companion Diagnostic Test 12/5/2013  More...
Genetic Test Maker 23andMe, Inc. Stops Marketing After FDA Warning 12/3/2013  More...
Chembio Diagnostics, Inc. (CEMI.OB) Files For CLIA Waiver With FDA For Point-Of-Care DPP(R) HIV 1/2 Assay 12/2/2013  More...
InControl Medical LLC Pelvic Floor Muscle Stimulators Receive Class 2 Medical License For Sale In Canada 12/2/2013  More...
Bedfont Scientific NObreath® Listed In National Institute for Clinical Excellence (NICE) Guidelines For FeNO Testing 11/26/2013  More...
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  More...
FDA Tells Google Inc.-Backed 23andMe, Inc. To Halt DNA Test Service 11/25/2013  More...
Bio-Imaging Research Achieves ISO 9001 Registration From The British Assessment Bureau 11/22/2013  More...
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  More...
SFL Managing Director Provides Further Update Regarding Revision Of EU Medtech Legislation 11/18/2013  More...
MicroTest Laboratories Release: Current Regulatory Expectations Affecting The Validation Of Reusable Medical Devices Is Subject Of Dec. 4th Seminar In Boston 11/13/2013  More...
Cochlear Limited Win OK by FDA Advisory Panel for First of Its Kind Hybrid Hearing Device 11/12/2013  More...
New York State Department of Health Issues Clinical Laboratory Permit to Empire Genomics 11/12/2013  More...
FDA Will Hold Dispute Resolution Panel for Wright Medical Technology, Inc. (WMGI)'s Rejected Augment Bone Graft 11/6/2013  More...
Sequenom Inc. (SQNM) Decision Continues to Dim Hopes. Are Genetic Diagnostic Claims Dead? 11/4/2013  More...
Federal Shutdown Stalled 100 Medical Device Submissions 11/1/2013  More...
RTI Surgical (RTIX) Announces Successful Resolution to FDA Warning Letter for Alachua, Fla. Facility 10/30/2013  More...
King Systems Slapped With FDA Warning Letter 10/30/2013  More...
Pathway Genomics Corporation Receives New York State Clinical Laboratory Permit 10/28/2013  More...
EOS Imaging (Formerly Known as biospace med) Obtains Regulatory Authorization to Sell Its Products in Japan 10/24/2013  More...
EOS Imaging (Formerly Known as biospace med) Obtains Regulatory Authorization to Sell Its Products in Japan 10/23/2013  More...
WuXi PharmaTech Co., Ltd. Receives CLIA Certification for Its Genomics Clinical Laboratory 10/17/2013  More...
Positron Corporation (POSC)'s Radioisotope Manufacturing Facility Receives ISO 9001 Certification 10/14/2013  More...
Spiracur and Century Medical, Inc. Announce Multiple SNaP System Sales in Japan After Ministry of Health, Labor and Welfare Grants Reimbursement 10/14/2013  More...
Persistent Systems Attains ISO 13485:2003 Certification, the International Quality Management Systems Standard for Medical Device Software 10/9/2013  More...
Private Equity Firm Citron Puts Intuitive Surgical, Inc. (ISRG) on Blast Over Adverse Events 10/8/2013  More...
Sequenom Inc. (SQNM) Files Premarket 510(k) Notification With FDA For IMPACT Dx™ System 10/3/2013  More...
GE Healthcare’s National Network of Radiopharmacies Receives Joint Commission Accreditation 9/30/2013  More...
QPharma, Inc.'s Medical Device Division Offers Guidance on UDI Final Rule 9/27/2013  More...
Ireland Finance Chief Denies Abbott Laboratories (ABT), Boston Scientific Corporation (BSX) Paid Little in Taxes 9/27/2013  More...
Integra LifeSciences Holdings Corporation (IART) Resolves Violations at New Jersey Manufacturing Facility 9/26/2013  More...
CARMAT SAS Obtains ANSM Approval in France to Carry Out the First Human Implants of Its Bioprosthetic Artificial Heart 9/24/2013  More...
XVIVO Perfusion AB Release: NOVEL Trial Recruitment of Patients Complete, FDA Has Decided That an Expert Panel Meeting Will be Held Q1 of 2014 9/20/2013  More...
Dallen Medical Files 510(k) for FDA Clearance on Sterile Packaging for Compressyn™ Staple Implants 9/17/2013  More...
Caliber Imaging & Diagnostics Welcomes Updated European Guideline on Basal Cell Carcinoma That Praises Confocal Microscopy 9/16/2013  More...
Ranbaxy Laboratories (RANBAXY.BO) Crashes on FDA Import Alert for Mohali Unit; Stock Falls -30.27% at Market Close (September 16, 2013) 9/16/2013  More...
FDA Rejects Delcath Systems, Inc. (DCTH)'s Cancer Therapy, Fires CEO 9/13/2013  More...
RTI Surgical Announces Successful Outcome to FDA Inspection of Alachua, Fla. Facility 9/11/2013  More...
Omeros Corporation (OMER) Submits OMS302 Marketing Authorization Application to European Medicines Agency 9/10/2013  More...
Genetic Technologies Limited (GTG.AX) Receives Certification for New York State 8/30/2013  More...
Aggredyne Earns ISO 13485 Certification for Medical Device 8/30/2013  More...
Vilex Receives ISO 13485:2003 Certification 8/26/2013  More...
Becton, Dickinson and Company (BDX) Supports the FDA's Proposal to Reclassify Rapid Influenza Tests 8/26/2013  More...
QPharma, Inc.'s Medical Device Division Advises Manufacturers to Prepare for UDI Compliance 8/22/2013  More...
AngioDynamics (ANGO) Applauds National Institutes of Health (NIH) and National Institute for Clinical Excellence (NICE)'s Updated Guidelines for Varicose Vein Treatment 8/19/2013  More...
Cardica, Inc. (CRDC) Submits MicroCutter XCHANGE™ 30 510(k) Application for Marketing Clearance 8/16/2013  More...
Century Medical, Inc. Submits Cardica, Inc. (CRDC) MicroCutter XCHANGE™ 30 Cartridge for Japanese Approval 8/12/2013  More...
Sequenom Inc. (SQNM) CMM's MaterniT21™ PLUS Testing Service Received Clinical Laboratory Permit From New York State 8/5/2013  More...
Cool Logistics India Celebrates International Certification 8/5/2013  More...
Verinata Health, Inc. Receives New York State Laboratory Permit for Verifi® Prenatal Test 8/2/2013  More...
Thubrikar's Next-Generation TAVI System Surpasses ISO Requirement for Durability and Achieves Other Milestones 8/2/2013  More...
BioLineRx Ltd. Announces CE-Mark Registration Trial Submission for Novel Treatment for Removal of Skin Lesions 7/29/2013  More...
Statement on New Dense Breast Notification Law in North Carolina From Atossa Genetics, Inc. (ATOS) 7/29/2013  More...
Standex-Meder Electronics Announces Expanded IP67 Approvals 7/29/2013  More...
Fenwal Receives 60601-1 3rd Edition Certification for Aurora™ Plasmapheresis System 7/25/2013  More...
Dallen Medical Files 510(k) for FDA Clearance on Tensyn™ Band for Syndemosis Repair 7/23/2013  More...
Yukon Medical, LLC. Receives ISO 13485 Certification 7/22/2013  More...
Invacare Corporation (IVC) Receives FDA Acceptance of Second Certification Audit Related to Consent Decree 7/16/2013  More...
Intuitive Surgical, Inc. (ISRG) May Not Have Tested Devices Properly 7/12/2013  More...
iMDsoft's IPad Anesthesia App Listed as Class I Medical Device by FDA 7/11/2013  More...
Centers for Medicare & Medicaid Services Issues Proposed Payment Rules Affecting Cytomedix Inc. (CMXI)'s AutoloGel™ for Chronic Non-Healing Wounds 7/10/2013  More...
Eli Lilly and Company (LLY): Centers for Medicare & Medicaid Services Wants More Amyvid Trials Before Approving Medicare Coverage 7/8/2013  More...
MBio Diagnostics, Inc. Receives ISO 13485: 2003 Certification 7/8/2013  More...
The Joint Commission Issues National Patient Safety Goal and Requirements for Medical Device Alarm Management 7/8/2013  More...
Itamar Medical Inc. Announced Today That the American Medical Association Has Awarded a CPT Category III Code to a Test Performed by Its EndoPATTM Proprietary Device 7/8/2013  More...
Smiths Detection Checked Baggage Threat Detection System Incorporating Analogic CT Technology Receives TSA Lab Certification 7/1/2013  More...
Illumina, Inc. (ILMN) Applies CE Mark to MiSeqDx™ Cystic Fibrosis System 7/1/2013  More...
Miyachi Unitek Announces Renewal of ISO 9001:2008 Certification 6/28/2013  More...
Miyachi Unitek Announces Receipt of CE Marking Standard for Alpha Series Glovebox 6/28/2013  More...
Medimetrics Confirms Capability for Design and Delivery of Medical Devices and Related Services by Gaining ISO 13485 Certification 6/25/2013  More...
CombiMatrix Corporation (CBMX) Granted Conditional Approval From New York State Department of Health to Market Prenatal Miscarriage Analysis Test 6/25/2013  More...
Good Start Genetics, Inc. Receives Approval to Conduct Genetic Screening in New York 6/24/2013  More...
Regulatory Affairs Professionals Society Opens Offices in Singapore and China 6/18/2013  More...
Foster Corporation Propell™ Compounds Improve Catheter Manufacturing in Low Durometer Polymers 6/18/2013  More...
BIOLASE Technology, Inc. (BIOL) Added to Two Major Indices for 2013 6/18/2013  More...
FDA Urges Protection of Medical Devices From Cyber Threats 6/14/2013  More...
FDA, Facing Cybersecurity Threats, Tightens Medical-Device Standards 6/14/2013  More...
Silicon Valley Biosystems' Computational Diagnostics Laboratory Receives CLIA Certification 6/13/2013  More...
Tetracore Inc. Announces the Successful Completion of a Comprehensive Laboratory Validation of the Tetracore BioThreat Alert® Lateral Flow Assay for the Rapid Detection of Ricin by the United States Department of Homeland Security 6/12/2013  More...
Solos Endoscopy, Inc. (SLSE.PK) and TUV SUD America Schedule Stage 2 ISO 13485 Audit for August 16, 2013 6/12/2013  More...
Acerde, the Leading Specialist in Next-Generation Rotating Anodes for Medical Imaging, Was Awarded the ISO 9001 Label and Has Ended a €1.2 Million Round of Fundraising With Truffle Capital 6/11/2013  More...
AirStrip Technologies, Inc. Becomes First Medical Device Mobility Solution to Receive DIACAP Certification From U.S. Air Force 6/11/2013  More...
Saladax Biomedical Inc. (SBI) Receives CLIA Laboratory Certification and Approval to Begin Clinical Laboratory Operations in Support of MyCare™ Portfolio 6/10/2013  More...
More FDA Inspection Troubles for Hospira, Inc. (HSP) 6/10/2013  More...
Becton, Dickinson and Company (BDX) Helps to Support the Implementation of New Sharps Instruments in Healthcare Regulations 6/10/2013  More...
CardioGenics Holdings Inc. Announces Internal Review Board Approval for Beta-Site Testing 6/5/2013  More...
Regulatory Affairs Professionals Society Webcast to Examine Medical Devices Regulation in Latin America 6/4/2013  More...
FDA Warns CooperSurgical, Inc. About Texas Manufacturing Plant 5/31/2013  More...
Inostics' Blood-based Mutation Testing Receives CLIA Certification 5/30/2013  More...
Quality First International Release: New ASEAN Draft Medical Device Directive: Will It Create the Hoped for Economic Boost for the Region? 5/23/2013  More...
Direct Flow Medical, Inc. Receives IDE Approval for U.S. Salus Trial of Transcatheter Aortic Heart Valve System 5/17/2013  More...
Invacare Corporation (IVC) Proving Itself to the FDA 5/14/2013  More...
Staff Shakeup Underway at Russian Medical Device Regulator, Emergo Group 5/14/2013  More...
SANUWAVE, Inc. Completes Investigator Meeting 5/13/2013  More...
BSD Medical (BSDM) Announces BSD-2000 Marketing Approval Submission to Taiwan Food and Drug Administration by Linden Bioscience 5/13/2013  More...
GE Healthcare’s Entire New CT Portfolio Meets MITA’s Smart Dose Standard 5/7/2013  More...
The Internationally Known Medical Device Regulatory Expert, Haroon Atchia Has Published the First Fundamental and Critical Examination of the Proposal Regulation 4/29/2013  More...
InSpire MD Receives Approval From FDA to Begin US Regulatory Trial 4/23/2013  More...
Global Regulatory Affairs Specialist ELC Group Receives Accreditation to Provide Readability Testing in Romania 4/23/2013  More...
Frog-Like Robot Will Help Surgeons, University of Leeds Study 4/18/2013  More...
Insight Genetics Receives ISO 9001:2008 Certification 4/17/2013  More...
US Regulatory Agency Provides Favorable Review and Recommends Path for Approval - TSO3 Inc. (TOS) to Pursue De Novo Process Classification 4/17/2013  More...
Rapid Micro Biosystems Announces ISO 9001:2008 Certification 4/16/2013  More...
Regulatory Affairs Professionals Society Webcast to Examine EU In Vitro Diagnostics (IVDs) Regulation 3/25/2013  More...
Meridian Bioscience, Inc. (VIVO) Announces illumigene® Group A Streptococcus and illumigene® Group B Streptococcus Tests Categorized "Moderate Complexity" by FDA 3/18/2013  More...
Troubles Continue for Intuitive Surgical, Inc. (ISRG) as Shares Keep Falling 3/15/2013  More...
WuXi PharmaTech Co., Ltd. Receives Letter From AAALAC Commending Animal Care at Suzhou Toxicology Facility as "Exemplary" 3/14/2013  More...
Regulatory Affairs Professionals Society, Singapore to Collaborate on First Medical Device Regulatory Training Program in Southeast Asia 3/14/2013  More...
SFL Announces New Training Courses on EU Medical Devices and Combination Products Regulations 3/11/2013  More...
Availability of BioPorto’s The NGAL TestTM for Siemens ADVIA® systems 3/5/2013  More...
Medtronic, Inc. (MDT) Scores Regulatory Approval to Update CE Mark for Drug-Eluting Stent 3/5/2013  More...
Zyomyx, Inc. Receives ISO 13485: 2003 Certification 2/28/2013  More...
Regulatory Affairs Professionals Society Medical Device Submission and Compliance Workshop to Feature FDA Regulators, Industry Experts 2/28/2013  More...
SpineGuard Wins Approval to Start Marketing PediGuard 2/27/2013  More...
Avita Medical Completes ISO Quality Audit, CE Mark Recertification 2/14/2013  More...
Guided Therapeutics, Inc. Passes Annual ISO Quality Audit Necessary for Continued CE Mark Certification 2/14/2013  More...
New Book From Regulatory Affairs Professionals Society Examines Risk Management for Drugs and Medical Devices 2/5/2013  More...
Resonance Health Limited (RHT.AX)’s FerriScan® R2-MRI Receives FDA Marketing Authorization as the First Imaging Companion Diagnostic Device for Exjade® in Patients With Non-Transfusion-Dependent Thalassemia (NTDT) 1/31/2013  More...
Spectranetics Corporation (SPNC) Announces Expansion Into Japan Peripheral Intervention Market 1/29/2013  More...
Solos Endoscopy, Inc. (SLSE.PK) and TUV SUD America Schedule Stage 1 ISO 13485 Audit for February 26, 2013 1/24/2013  More...
MiCardia Corporation Receives Notification of a New German Reimbursement Code for the Adjustment of Its enCorSQ Mitral Valve Repair System 1/23/2013  More...
National Institute for Clinical Excellence (NICE) Backs AF Blood Pressure Device 1/18/2013  More...
Given Imaging Ltd. (GIVN) Announces New Reimbursement Code for Its SmartPill® Wireless Motility Capsule Procedure 1/17/2013  More...
Medical Implant Manufacturer RMI Achieves AS9100C Aerospace Certification to Provide Products to the Aviation, Defense and Space Industries 1/17/2013  More...
Connecticut Spring & Stamping Pursues ISO 13485 Medical Certification for Quality Management 1/17/2013  More...
Advanced BioMedical Technologies Inc. (ABMT)'s Quality Management System Receives ISO 13485:2003 Certification 1/15/2013  More...
NanoViricides, Inc. (NNVC.PK) Retains AES Clean Technology, Inc. for Design, Engineering and Construction of the Cleanroom Suite in its Previously Announced cGMP Production and Laboratory Facility 1/14/2013  More...
Cook Medical Will "Not Give Up" Medical Device Tax Fight 1/11/2013  More...
Laboratory Corporation of America Holdings (LabCorp) (LH) Biorepository Receives Industry Accreditation From College of American Pathologists 1/9/2013  More...
St. Jude Medical (STJ) Admits Quality-Control Issues, Promises Improvements 1/9/2013  More...
Guided Therapeutics, Inc. Successfully Completes Canadian Standard Association Requirements for LuViva® Advanced Cervical Scan 1/7/2013  More...
Sensimed AG Receives a New Reimbursement Code in the USA by the American Medical Association for Intraocular Pressure Monitoring 1/3/2013  More...
AITbiotech Secured CE-IVD Certification for Its Influenza (Flu) and Mycobacteria Tuberculosis (MTB) Molecular Diagnostic Assays 1/2/2013  More...
FDA Details Changes to Medical Device Review Groups 12/20/2012  More...
Exponent Inc. (EXPO) Release: Failure Analysis, Product Recalls, and Liability: Preventative Measures to Help Prevent the FDA From Knocking on Your Door 12/20/2012  More...
CardiacAssist, Inc. Receives FFA Sciences IDE Approval for Use of the TandemHeart System in Pivotal Clinical Study 12/18/2012  More...
BioLargo, Inc. (BLGO.PK) Achieves Breakout Milestones in Advanced Wound Care on Track for FDA 510(k) Submission and Commercialization 12/17/2012  More...
Flexpoint Sensor Systems Inc. Completes Certification for Pressure Relief Device 12/14/2012  More...
InVivo Therapeutics Corporation (NVIV) Requests Humanitarian Use Device Designation With FDA 12/14/2012  More...
Maquet Cardiovascular LLC Announces FDA Panel Votes to Reclassify Intra-Aortic Balloon Pumps to a Class II Designation in Certain Indications 12/13/2012  More...
Cohera Medical, Inc. Receives IDE Approval to Begin First No-Drain Clinical Study of TissuGlu® Surgical Adhesive in the U.S. 12/13/2012  More...
Abiomed (ABMD) Release: FDA 515i Reclassification Panel Recommends Class III Status for Temporary Ventricular Support Devices in the Non-Roller Type Cardiopulmonary Bypass Blood Pumps Category 12/7/2012  More...
Marcus Evans, Life Science and Pharma Conferences: Establish Strategies for Device Recalls and Corrections 12/5/2012  More...
Vasomedical Inc. (VASO)'s EECP® Therapy Receives Class IIb Rating in the New ACCF/AHA 2012 Clinical Guideline for SIHD 11/27/2012  More...
Final FDA Artificial Pancreas Guidance a Milestone for People With Type 1 Diabetes 11/14/2012  More...