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Medical Dev. & Diag. - Regulatory
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...
Conceptus, Inc. (CPTS) Praises France's UNCAM Decision to Remove Age Restrictions on Reimbursement for Essure® Permanent Birth Control 11/14/2012  More...
Nelson Laboratories Compliant With New FDA Medical Device Registration Requirement 11/14/2012  More...
Oxford Immunotec Limited RT-SPOT.TB Receives Regulatory Approval and Reimbursement Coding in Japan 11/13/2012  More...
Corgenix Medical Corporation (CONX) Receives Regulatory Approval for Sale of AspirinWorks® in China 11/12/2012  More...
CellAegis Devices Inc. Announces Initiation of Clinical Testing of Remote Ischemic Conditioning (RIC) Using the autoRIC™ Device for Patients Undergoing Partial Nephrectomy 11/12/2012  More...
STD Med, Inc. Receives ANVISA Registration for Class III Medical Devices in Brazil 11/9/2012  More...
NanoSight Limited Joins the EU Methods List Relating to "Nanomaterials" 11/7/2012  More...
Nanosphere, Inc.'s Bloodstream Infection Test Designated Moderate Complexity by FDA 11/2/2012  More...
GI Dynamics Receives FDA Approval to Commence Pivotal Clinical Trial of EndoBarrier® 10/30/2012  More...
Exagen Diagnostics, Inc. Receives Avise SLE Certification In New York 10/26/2012  More...
Philips Respironics Simplygo Portable Oxygen Concentrator Receives FAA-Approval; Oxygen Patients Can Fly With Simplygo 10/25/2012  More...
Exagen Diagnostics, Inc. Receives Avise SLE Certification in New York 10/25/2012  More...
Merit Medical Systems, Inc. (MMSI) Announces FDA Completes Evaluation 10/24/2012  More...
Sequenta Earns CLIA Certification 10/24/2012  More...
Quest Diagnostics Inc. (DGX) Announces First EHRs Certified Under Laboratory-based Health IT Quality Solutions™ Program 10/19/2012  More...
EU Follows US Nod for Eli Lilly and Company (LLY)'s Brain Plaque Test 10/19/2012  More...
St. Jude Medical (STJ) Sees Possible FDA Warning Letter; Shares Tumble 10/17/2012  More...
Fluxion Biosciences Registers South San Francisco Facility as Medical Device Establishment With FDA 10/15/2012  More...
Solos Endoscopy, Inc. (SLSE.PK) Reports Significant Progress on ISO 13485 Certification and Audit 10/11/2012  More...
International Isotopes (INIS) Announces Receipt of the Nuclear Regulatory Commission License for the Planned Depleted Uranium De-Conversion and Fluorine Extraction Processing Facility 10/4/2012  More...
Marcus Evans, Medical Device Summits Release: Monitoring the Safety of Post-Market Medical Devices 10/3/2012  More...
Mauna Kea Technologies Announces Important Regulatory Clearances in Turkey 10/1/2012  More...
Roche Diagnostics Corporation (ROG.VX) Release: FDA Grants CLIA-Waived Status to CoaguChek XS Plus System for PT/INR Testing at the Point of Care 10/1/2012  More...
Genetic Technologies Limited (GTG.AX) Announces BREVAGen™ Attains Clearance for Sale Into Florida 9/25/2012  More...
American College of Cardiology Certifies LUMEDX for Software Interoperability Between Four Registries 9/25/2012  More...
Boston Scientific Corporation (BSX) Release: Bronchial Thermoplasty Awarded Category I CPT® Procedure Codes 9/21/2012  More...
Given Imaging Ltd. (GIVN) Files for Japanese Regulatory Approval of PillCam COLON 2 9/20/2012  More...
Nuvolase Inc. Receives ISO 13485 Certification 9/18/2012  More...
USDA Issues Letter of No Objection for Neogen Corporation (NEOG)'s NeoSEEK™ STEC Detection System 9/14/2012  More...
FDA Drug Review Deal Set to Unravel as Fiscal Cliff Looms 9/11/2012  More...
CardioComm Solutions Inc. (CCG) Files for FDA for Clearance of GUAVATM II, a New ECG Viewer With ECG Algorithm Technologies 9/11/2012  More...
NxStage Medical, Inc. (NXTM) Submits Formal Comments to CMS to Improve Patient Access to Life-changing More Frequent Home Hemodialysis Therapy 9/7/2012  More...
International Isotopes (INIS) Announces Nuclear Regulatory Commission Approval of the Final Environmental Impact Statement for the Planned Depleted Uranium De-Conversion and Fluorine Extraction Processing Facility 9/5/2012  More...
Cerus Corporation (CERS) Announces INTERCEPT Blood System for Platelets Regulatory Submission for Approval in South Africa 9/4/2012  More...
Sunshine Heart Submits Investigational Device Exemption to FDA for C-Pulse(R) System Pivotal Trial 8/31/2012  More...
Veracyte, Inc. Receives New York State License for Afirma® Gene Expression Classifier 8/29/2012  More...
FDA Not Satisfied With Medtronic, Inc. (MDT)'s Response to Warning Letter About Manufacturing Guideline Violations 8/23/2012  More...
Axiom Worldwide Delists and Terminates US FDA 510(k)s for the DRX9000 Series of Products 8/23/2012  More...
Quest Diagnostics Inc. (DGX) Blueprint for Wellness® Earns URAC's Comprehensive Wellness Accreditation 8/23/2012  More...
Manhattan Isotope Technology Completes Drug Master File With FDA 8/23/2012  More...
Solos Endoscopy, Inc. (SLSE.PK) Retains TUV SUD America to Complete ISO 13485 Certification and Audit 8/23/2012  More...
Inogent Laboratories Clears the Pharmaceuticals and Medical Devices Agency (PMDA), Japan Audit 8/21/2012  More...
NanoLogix, Inc. (NNLX) Rapid Diagnostic Technologies Set to Enter Market Under FDA 510K-Exempt Status 8/21/2012  More...
Agendia BV Earns ISO Certification for Facilities in Amsterdam and Irvine 8/21/2012  More...
Delcath Systems, Inc. (DCTH) Submits New Drug Application for Proprietary Chemosaturation System to FDA 8/15/2012  More...
Breathe Technologies, Inc.'s Non-Invasive Open Ventilation (NIOV™) System Approved for Department of Veterans Affairs Federal Supply Schedule 8/14/2012  More...
FDA Restricts Use of Stryker Corporation  (SYK) Brain Stent 8/9/2012  More...
Medical Equipment Solutions and Applications Earns Swiss Accreditation 8/7/2012  More...
Carestream Health, Inc.'s Vue RIS Receives ONC-ATCB Certification as Complete EHR for Stage 1 of Meaningful Use 8/1/2012  More...
Google Inc.-Backed 23andMe, Inc. Seeks FDA Approval for Personal DNA Test 7/31/2012  More...
HTG Molecular Diagnostics, Inc. (Formerly Known as High Throughput Genomics, Inc.) Achieves ISO 13485:2003 Certification 7/30/2012  More...
AEterna Zentaris (AEZS) Requests Fast Track Designation From the FDA for AEZS-130 as Diagnostic Test for Adult Growth Hormone Deficiency 7/24/2012  More...
BG Medicine Announces 510(k) Filing for the ARCHITECT Galectin-3 Assay on the Abbott Laboratories (ABT) ARCHITECT Automated Platform 7/20/2012  More...
Second Sight Scores Date With FDA for Review of Retina Prosthesis System 7/20/2012  More...
Analogic Corporation (ALOG)'s Cobra Checkpoint CT System Achieves European Standard Allowing Liquids and Laptops to Remain in Carry-On Baggage 7/18/2012  More...
American Bio Medica Corporation (ABMC) Announces Signing of Consent Decree Related to Its OralStat® Product 7/10/2012  More...
University of Southern California School of Pharmacy Brings Regulatory Science Classes to Bay Area 7/6/2012  More...
VisionCare Ophthalmic Technologies Announces New Reimbursement Code for Telescope Implant Procedure 7/3/2012  More...
CVRx, Inc. Tracks Hypertension-treating Heart Implants With Euro Registry 7/3/2012  More...
NeuroSigma, Inc. Receives Global Quality Control Certification 7/2/2012  More...
OraSure Technologies, Inc. (OSUR) Release: OraQuick® In-Home HIV Test Receives Unanimous Positive Recommendation from FDA Advisory Committee 6/27/2012  More...
Rosetta Genomics Ltd. (ROSG) Announces New York State Approval for miRview(R) Lung 6/26/2012  More...
Medgenics, Inc. Receives Orphan Drug Designation from FDA for INFRADURE Biopump to Treat Hepatitis D 6/20/2012  More...
Viveve Receives Health Canada Medical Device License for Non-Surgical Treatment to Improve Women's Sexual Satisfaction After Childbirth 6/18/2012  More...
SDIX (SDIX) STEC Food Safety Product Receives USDA MLG Designation 6/13/2012  More...
Stratatech Corporation’s StrataGraft® Skin Substitute Granted FDA Orphan Drug Designation 6/13/2012  More...
Regenicin, Inc. Release: FDA Issues Orphan Status Approval for PermaDerm® 6/13/2012  More...
Sunshine Heart Receives Health Canada Approval to Modify Its Ongoing Investigational Study to Use the Next Generation C-Pulse(R) System Driver 6/8/2012  More...
Medline Industries, Inc. Receives Global ISO 14001 Certification 6/8/2012  More...
Small Bone Innovations, Inc. Release: Kansas State Workers Compensation Program Adopts Medical Treatment Guidelines Recommending STAR™ Ankle Replacement System Exclusively 6/8/2012  More...
EDAP TMS S.A. (EDAP) Highlights Recent UK NICE Positive Guidance for Focal Therapy Using HIFU to Treat Localized Prostate Cancer 6/7/2012  More...
W. L. Gore & Associates, Inc. Participates in FDA Circulatory System Devices Advisory Panel Meeting 6/7/2012  More...
Michigan Biosciences Organization - MichBio, as Part of State Medical Technology Alliance,  Urges Repeal of the Medical Device Tax 6/6/2012  More...
IntelligentMDx Receives ISO Certification for Manufacturing Capabilities Compliant With the Canadian Medical Devices Conformity Assessment System 6/6/2012  More...
Royer Biomedical, Inc. Receives FDA Approval to Proceed With Human Testing (IND 111446) on 5/25/2012 for its AppliGel Polymer Drug Delivery System 6/1/2012  More...
Fluke Biomedical Device First to Achieve Environmentally-Friendly Label 5/30/2012  More...
Medtronic, Inc. (MDT) CEO: Supreme Court Ruling Won't Stop Health Care Integration 5/29/2012  More...
Intelerad Medical Systems Meaningful Use Module Receives Complete EHR Certification 5/29/2012  More...
Systagenix Wound Management Release: New Consensus on Appropriate Usage of Silver Wound Dressings Launched 5/29/2012  More...
General Electric Company  (GE), Royal Philips Electronics N.V. (PHG) Get FCC Approval for Medical Use of Airwaves 5/25/2012  More...
Solos Endoscopy, Inc. (SLSE.PK) Releases ISO 13485 Certification and CE Mark Schedule With Work to Begin May 29 5/23/2012  More...
FDA's $6.4 Billion Plan for Quick Reviews Moves to Senate 5/21/2012  More...
Alpha Source, Inc. Receives National Certification from the Women's Business Enterprise National Council as a Women's Business Enterprise 5/17/2012  More...
Sorin Group S.p.A. (SRN) Receives Regulatory Approval to Market Memo 3D(TM) Annuloplasty Ring in Japan 5/16/2012  More...
Arterial Remodeling Technologies Receives Regulatory Approval to Begin First-In-Man "ARTDIVA" Clinical Trial With its Next-generation Bioresorbable Stent 5/15/2012  More...
TriE Medical Receives ISO 13485 Certification 5/15/2012  More...
Key Panel Ok's New FDA Bill 5/11/2012  More...
Courtagen Life Sciences, Inc. Submits Pre-IDE Information Package for the Avantra® Q400 Workstation and QPDx® BioChip 5/9/2012  More...
SANUWAVE, Inc. Receives Conditional Approval from the FDA on Clinical Trial Plan for dermaPACE 5/8/2012  More...
Allergan Inc. (AGN) Receives U.S. Subpoena Over Weight Loss Device 5/8/2012  More...
Solos Endoscopy, Inc. (SLSE.PK) to Finalize ISO 13485 Certification and CE Mark Initiative with Expert Resource for Endoscopic Instruments 5/4/2012  More...
Lombard Medical Technologies Regulatory Update 5/2/2012  More...
Medical Brands Announces the First Use of Medical Claims in the OTC for Treating and Preventing Urinary Tract Infections 5/2/2012  More...
MicroTest Laboratories Release: Industry Perspective on Reusable Medical Device Cleaning and Validation Requirements Outlined in New Management Brief 5/1/2012  More...
Quidel Corporation (QDEL) Receives CLIA Waiver for Its Sofia(TM) Analyzer and Sofia Influenza A+B Fluorescent Immunoassay (FIA) 4/23/2012  More...
NeuroMetrix, Inc. (NURO) Files 510(k) for SENSUS™ Pain Therapy Device 4/18/2012  More...
Medtronic, Inc. (MDT) CEO Vows to Boost Safety Monitoring of Devices 4/17/2012  More...
InVivo Therapeutics Corporation Expects to Commence Human Study after Meeting on IDE Filing for Biopolymer Scaffolding to Treat Spinal Cord Injuries 4/13/2012  More...
Cardio3 BioSciences Granted GMP Certification 4/12/2012  More...
PICC Excellence Now Offers PICC Certification 4/12/2012  More...
Nelson Laboratories Advises Reusable Medical Device Manufacturers to Follow New FDA Guidance 4/10/2012  More...
Tangent Medical Technologies, Inc. Submits FDA 510(k) for NovaCath(TM) Secure IV Catheter System 4/10/2012  More...
FDA Workers Pressured to Approve Unsafe Medical Devices 4/9/2012  More...
Life Technologies (LIFE) Receives the First and Only PCR-based FDA Method Equivalency for Salmonella Enteritidis in Poultry Eggs and Environmental Samples 4/6/2012  More...
Former FDA Chief Scientist Presents 10 Points for Regulatory Reform 4/6/2012  More...
OraSure Technologies, Inc. (OSUR) Release: FDA Sets Date for Advisory Committee Review of OraSure Over-the-Counter Rapid HIV Test 4/4/2012  More...
ESTECH Announces FDA Approval to Begin Enrollment in ATTAC-AF IDE Trial for the Treatment of Atrial Fibrillation During Cardiac Surgery 4/3/2012  More...
Aerocrine: The American Thoracic Society & AAAAI Issue a Joint Position Statement in Support of the American Thoracic Society Guidelines on FeNO 4/2/2012  More...
GenMark Diagnostics (GNMK) Enters into License Agreement with PerkinElmer, Inc. (PKI) for Microfluidics Patent Portfolio 3/29/2012  More...
AdvaMed's Protest Against Medical Reform's Tax on Devices Hits Philadelphia 3/27/2012  More...
Chroma Certified a "Green Partner" by Sony 3/27/2012  More...
LDRA Offers IEC 62304 and ISO 14971 Certification-Readiness Services for Medical Devices 3/26/2012  More...
St. Jude Medical (STJ) Announces Next-Generation PressureWire for FFR Measurement 3/23/2012  More...
Johnson & Johnson (JNJ) Marketed Vaginal Mesh Implant Without U.S. Approval 3/22/2012  More...
Cerus Corporation (CERS) Submits Investigational Device Exemption (IDE) Supplement to FDA for Phase III INTERCEPT Red Blood Cell Study 3/21/2012  More...
Anulex Technologies, Inc. Resolves FDA Warning Letter 3/21/2012  More...
Syneron Medical Ltd. (ELOS) Takes Voluntary Field Action Regarding the LiteTouch Dental Laser Product in Europe 3/20/2012  More...
Ultera Systems, Inc. Receives Clearance to Market Ultrasound Platform Device in Mexico 3/16/2012  More...
Medtronic, Inc. (MDT) Receives Health Canada License for Deep Brain Stimulation Therapy in Refractory Epilepsy Patients 3/15/2012  More...
Acacia Research Corp. (ACTG) Subsidiary Licenses Medical Monitoring Technology to Oridion Capnography, Inc. 3/14/2012  More...
Sunshine Heart Announces FDA Completes Review of C-Pulse(R) Feasibility Data 3/14/2012  More...
Regulatory Affairs Professionals Society Webcast Tomorrow to Cover FDA-Compliant Off-label Info. 3/13/2012  More...
EnteroMedics (ETRMD) Release: American Medical Association Adopts New Category III CPT Codes for Vagus Nerve Blocking Therapy 3/12/2012  More...
Given Imaging Ltd. (GIVN) Announces Publication of Colon Capsule Endoscopy Guidelines in Endoscopy 3/12/2012  More...
Avedro, Inc. Announces FDA Submission for Corneal Cross-linking 3/9/2012  More...
FDA Warns Synthes, Inc. (SYST) on Device Violations,Threatens Fine 3/7/2012  More...
TYRX Announces New Medicare ICD-9 Code for the AIGISRx Antibacterial Envelope 3/6/2012  More...
Cappella Medical Devices Ltd Receives Regulatory Approval in India to Market its Proprietary Sideguard® Technology Platform 3/5/2012  More...
National Health Service Recommends Assessment for Elevated Protease Activity Using Diagnostic Test to Help Decide Venous Leg Ulcers Treatment Pathway, Reports Systagenix 3/5/2012  More...
Atossa Genetics, Inc.' National Reference Laboratory for Breast Health Receives CLIA Certification 3/5/2012  More...
Australia's Therapeutic Goods Administration is Lax on Device Safety 3/5/2012  More...
Solos Endoscopy, Inc. (SLSE.PK) Successfully Completes Level I FDA Inspection 3/5/2012  More...
AtriCure, Inc. (ATRC) Gets FDA Nod for Stroke Safety and Feasibility Trial 3/2/2012  More...
Thermo Fisher Scientific (TMO) Announces 510(k) Clearance of ImmunoCAP Tryptase Assay 3/2/2012  More...
Sequana Medical 's Alfapump(R) System Receives Reimbursement in Germany for Breakthrough Technology in Ascites Management 3/2/2012  More...
Health Canada Approves Medical Device License for Carestream Health, Inc. DRX-Revolution Mobile X-Ray System 3/1/2012  More...
Acacia Research Corp. (ACTG) Subsidiary Licenses Medical Monitoring Technology to Philips Electronics North America Corporation 3/1/2012  More...
Nelson Laboratories Presents Testing Processes for Reusable Medical Devices 3/1/2012  More...
Cell>Point Executes Asia Pacific License with HYUN IMC for Cancer and Heart Disease Diagnostic Imaging Agent, Technetium-99m EC-G 2/29/2012  More...
Avedro, Inc. Options Rights to Intellectual Property 2/29/2012  More...
Regulatory Affairs Professionals Society Webcast Today to Cover Labeling and Promotion of Medical Devices in China 2/29/2012  More...
Bioptigen Device Receives Canadian Regulatory Clearance 2/28/2012  More...
AB SCIEX Achieves ISO 13485 Certification for Manufacturing of LC/MS Systems 2/27/2012  More...
Restoration Robotics, Inc. Release: ARTAS™ System Receives Canadian Medical Device License to Treat Hair Loss 2/27/2012  More...
Integrated Medical Systems International, Inc. Offers Steps to Help Facilities Ensure Sterile Processing Practices are in Compliance 2/24/2012  More...