BioSpace Collaborative

Academic/Biomedical Research
News & Jobs
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  C2C Services & Suppliers™
Europe
Asia

DIVERSITY

PROFILES
Company Profiles

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Research Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
Get Our Industry eNewsletter FREE email:    
Medical Dev. & Diag. - Approvals
Zyno Medical Wins FDA Approval For Ambulatory Infusion Pump 10/24/2014
Reflow Wins FDA Approval And Initial US Clinical Use Of The Wingman35 Crossing Catheter 10/23/2014
Avacen Medical Wins FDA Nod For First Medical Device With Internal Game Mode 10/22/2014
Centric Medical™ Wins FDA Approval For TARSA-LINK™ Internal Fixation System for Foot and Ankle 10/22/2014
Sorin Group S.p.A. (SRN) Announces CE Mark Approval And First Implant Of MEMO 3D ReChord™ 10/22/2014
Atossa Genetics, Inc. (ATOS) Receives CE Mark For The ForeCYTE Breast Aspirator Device 10/22/2014
West Pharmaceutical Services's Vial2Bag DC Device Receives U.S. FDA 510(K) Clearance And CE Mark 10/21/2014
Boston Scientific Corporation (BSX) Receives FDA And CE Mark Approval For New CoverEdge™ Surgical Leads For The Precision Spectra™ Spinal Cord Stimulator (SCS) System 10/21/2014
IOMED, Inc. (IOX) Receives CE Mark Clearance For Bioweld1™ Cold Plasma System 10/20/2014
FSC Laboratories Wins FDA Approval For Flexichamber™ 10/20/2014
FDA Approves DexCom (DXCM) SHARE™, The First Remote Mobile Communications Device Used For CGM 10/20/2014
OssDsign’s Cranioplug Receives Marketing Approval In The U.S. 10/20/2014
Boston Scientific Corporation (BSX) Announces Pacemaker CE Mark With Options For Magnetic Resonance Imaging 10/17/2014
FDA Permits Marketing Of Vesiflo’s inFlow™ Device For Women 10/16/2014
Thermo Fisher Scientific (TMO) Announces Its Ion PGM Dx Next Generation Sequencing System Is Now CE-Marked For In Vitro Diagnostic (IVD) Use 10/16/2014
Quidel Corporation (QDEL) Receives FDA Clearance For Its Lyra™ Molecular PCR Assay For The Detection Of Human Parainfluenza Viruses (HPIV), Types 1, 2 And 3 10/16/2014
TriVascular, Inc. (TRIV) Wins FDA Approval Of CustomSeal™ Technology For The Ovation Prime® System 10/15/2014
Konica Minolta Medical Imaging U.S.A, Inc. (KPI1.BE) Wireless Digital Radiography Solution For Extreme Environments Receives FDA Clearance 10/15/2014
Precision Spine Wins FDA Approval For VAULT®-C Anterior Cervical Interbody Fusion Device 10/15/2014
Medical Device Firm iTaumacare® Receives Expanded Indication From FDA For iTClamp® Hemorrhage Control System 10/15/2014
Bracco Diagnostics Inc. Release: FDA Approves A New Ultrasound Imaging Agent 10/14/2014
Medtronic, Inc. (MDT) Announces FDA Approval Of Pacing Lead For Full-Body MRI Scans 10/14/2014
Quidel Corporation (QDEL) Receives FDA Clearance For Its Lyra(R) Molecular PCR Assay For The Detection Of Adenovirus 10/14/2014
FDA Approves VisionCare Ophthalmic Technologies's Telescope Implant For Macular Degeneration In Patients 65 Years And Older 10/13/2014
Nanosphere, Inc. Release: FDA Clears Additional Viral Targets On Verigene Enteric Pathogens Test 10/13/2014
Covidien plc (COV) Wins FDA Approval For Nellcor™ Portable Spo2 Patient Monitoring System 10/10/2014
Masimo Corporation (MASI) Wins CE Mark Of Eve™ Newborn Screening Application for Radical-7 10/10/2014
FDA Approves Lutonix, Inc.'s First Drug-Coated Angioplasty Balloon Catheter To Treat Vascular Disease 10/10/2014
Vectura Group plc (VEC.L) Release: Approval In Portugal For Innovative Respiratory Inhaler AirFluSal® Forspiro® 10/9/2014
WOUNDCHEK™ Laboratories Receives Market Clearance For WOUNDCHEK™ Protease Status In Canada 10/9/2014
Kubtec Announces FDA Approval Of World’s First Breast Specimen Tomosynthesis System During Breast Cancer Awareness Month 10/7/2014
Cynosure, Inc. (CYNO) Release: PicoSure® Is FDA-Cleared For Treatment Of Fine Lines And Wrinkles 10/6/2014
B.Braun Medical Receives FDA Approval For New Large-Volume Injection Containers 10/2/2014
Direct Flow Medical, Inc. Receives CE Mark For An Enhanced And Simple To Use Transfemoral Aortic Heart Valve Delivery System 10/2/2014
Vision-Sciences, Inc. (VSCI) Announces CE Mark And European Launch Of Next Generation Endosheath® Bronchoscopy System 10/1/2014
LoneStar Heart, Inc. Receives European Approval To Market Its Algisyl-LVR® Hydrogel Implant For The Treatment Of Advanced Heart Failure 10/1/2014
CFI Medical And BIOTRONIK Announce CE Mark For Zero-Gravity™ Suspended Radiation Protection System 10/1/2014
Intuitive Surgical, Inc. (ISRG) Wins FDA Approval For First Single-Site® Wristed Needle Driver For da Vinci® Si® Surgical System 9/30/2014
FDA Clears Next-Generation SURGIMAP 2.0 Software, First Pre-Operative Planning Platform For Personalized Spinal Implants 9/30/2014
EDP Biotech Corporation Announces CE Mark Approval For Colomarker An In Vitro Diagnostic Aid In Early Detection Of Colon Cancer And Plans For Commercialization In Europe 9/30/2014
Alimera Sciences (ALIM), pSivida Corp (PSDV) Eye Implant Finally Wins FDA Approval 9/29/2014
CVRx, Inc. Wins CE Mark Approval Of The Barostim Neo System™ To Treat Heart Failure 9/29/2014
Cesca Therapeutics Announces Approval Of Its AXP ® Autoxpress ® System In Taiwan 9/29/2014
InfraReDx Receives Regulatory Approval Of TVC Imaging System In Japan 9/29/2014
Occlutech Obtains European CE Approval For Its Dedicated Paravalvular Leak Closure Device 9/29/2014
Allergan Inc. (AGN) Announces FDA Approves Revised Indication For OZURDEX ® (Dexamethasone Intravitreal Implant) 0.7 Mg For The Treatment Of Diabetic Macular Edema 9/29/2014
BSD Medical (BSDM)’s China Distributor Receives China Food And Drug Administration Marketing And Import License Approval For The BSD-2000 Hyperthermia System 9/29/2014
Clear Guide Medical Receives FDA 510(K) Clearance On First Product, The CLEAR GUIDE ONE 9/26/2014
Miacom Diagnostics Announces Health Canada Approval For HemoFISH Assays, A Platform Technology To Analyze Positive Blood Cultures In 30 Minutes 9/26/2014
Trinity Biotech (TRIB) Announces CE Marking of New Meritas Heart Failure (BNP) Point-of-Care Test 9/25/2014
Reflow Announces CE Mark And Initial Clinical Use Of The Wingman35 Crossing Catheter And Spex™ Shapeable Support Catheter 9/25/2014
RDT Announces Significant Market Clearances For Its Tempus Pro™ Advanced Medical Monitor 9/24/2014
Unisense FertiliTech A/S Wins FDA Approval For Tool To Aid In Embryo Selection To Improve IVF Treatment 9/24/2014
Clear-Cut Medical Announces CE Marking Of Its ClearSight™ MRI System For The Examination Of Breast Tissue 9/23/2014
Life Spine Wins FDA Approval Of LONG BOW™ Expandable Lateral Interbody System 9/23/2014
Somahlution Announces CE Mark And European Launch Of DuraGraft® Vascular Conduit Solution 9/23/2014
W. L. Gore & Associates, Inc. Wins FDA Nod For Endovascular Treatment Of In-Stent Restenosis With The GORE® VIABAHN® Endoprosthesis 9/22/2014
Medtronic, Inc. (MDT) Announces CE Mark And European Launch Of TYRX™ Absorbable Antibacterial Envelope 9/22/2014
St. Jude Medical (STJ) Wins CE Mark Approval For Tendril STS, IsoFlex Optim 9/22/2014
Intuitive Surgical, Inc. (ISRG)'s Robot Cleared By The FDA For Base Of Tongue Surgery 9/19/2014
Straub Medical AG Obtains Approval For Rotarex®S And Aspirex®S Endovascular Catheters In Brazil 9/18/2014
Microvisk: "World First" Medical Device Accredited For European Sales 9/18/2014
FDA Clears Siemens Healthcare (SI)’ SOMATOM Scope CT System 9/18/2014
NxStage Medical, Inc. (NXTM) Wins FDA Approval Of Single Needle Technology 9/16/2014
Eternity Healthcare Release: FDA Approves The Use Of A Needle-Free Injection Device To Administer The Influenza Vaccine 9/16/2014
Quantel Medical Inc.'s Vitra™ PDT Laser Receives CE Mark Approval 9/12/2014
FDA Approves Medtronic, Inc. (MDT)'s Euphora Non-Compliant Coronary Balloon Catheter 9/12/2014
IMRIS Neurosurgical HFD Rocker Arm Wins FDA Approval 9/11/2014
CivaTech Oncology, Inc. Wins FDA Approval For CivaSheet™ Brachytherapy Device 9/11/2014
Cohera Medical, Inc.'s TissuGlu® Surgical Adhesive Wins Approval For 18 Month Shelf Life in Europe 9/10/2014
Mazor Robotics Gains China Approval for Surgical Guidance System 9/10/2014
EOS Imaging (Formerly Known as biospace med) Obtains Marketing Approval In Brazil 9/8/2014
Goodbye Glucose Finger Sticks? Abbott Laboratories (ABT) Wins European OK For Wearable Monitor 9/8/2014
Stereotaxis, Inc. (STXS) Wins FDA Approval Of Vdrive™ With V-Loop™ System 9/4/2014
EndoCross Receives CE Mark Approval For The ENABLER-C Coronary Catheter System For The Crossing Of Coronary Chronic Total Occlusions 9/4/2014
Esaote S.p.A. Receives FDA Clearance For Its Compact Mylab Six Ultrasound System 9/4/2014
GE Healthcare's 3D Mammography Device Wins FDA Approval 9/3/2014
K2M Receives 510(K) Clearance & CE Mark For MESA Hooks Used In Complex Spine Procedures 9/3/2014
Amoy Diagnostics Co. LTD. Got CFDA Approval For Its ROS1 And ALK&ROS1 Testing Kits 9/3/2014
Medtronic, Inc. (MDT) Announces CE Mark For Recapturable CoreValve Evolut R System 9/3/2014
CeloNova BioSciences Receives Expanded Indication in Liver Cancer 9/3/2014
Otoharmonics Receives FDA 510(K) Clearance For The Levo® System 9/3/2014
Ortho Development Corporation Receives FDA Clearance For Alpine Hip Stem 9/2/2014
Cancer Genetics, Inc. (CGIX)' Proprietary IVD For Cervical Cancer, FHACT®, Receives CE 9/2/2014
Allergan Inc. (AGN) Announces OZURDEX® (Dexamethasone 700 Mcg Intravitreal Implant In Applicator) Now Approved In The European Union For The Treatment Of Diabetic Macular Edema 9/2/2014
Sophia Genetics Becomes The First European Company To Obtain CE-IVD Mark For Clinical Use Of Next Generation Sequencing Bioinformatics Pipeline For Routine Genetic Testing 9/2/2014
Masimo Corporation (MASI) Announces CE Mark And Limited Market Release Of Rainbow® DCI-Mini(TM) -- First Noninvasive Total Haemoglobin (Sphb®) Spot-Check Sensor For Infants And Small Children 8/29/2014
CardiacAssist, Inc. Wins FDA Approval For Its PROTEK Duo Veno-Venous Cannula 8/28/2014
Nonin Medical, Inc. Announces FDA Clearance Of Nonin Model 3231 USB Pulse Oximeter 8/28/2014
EMIT Corporation Awarded CE-Mark For Hypothermx® Intravenous Fluid And Blood Warming Devices With Sterile Fluid Paths 8/28/2014
Medtronic, Inc. (MDT) Receives Clearance For The SHILLA™ Growth Guidance System 8/28/2014
Hansen Medical (HNSN) Announces U.S. Commercial Availability Of Magellan™ Transport System 8/27/2014
Nipro Diagnostics, Inc. Wins FDA Approval For Its Newest Blood Glucose Monitoring Systems 8/26/2014
CorMatrix Cardiovascular Wins FDA Approval For CorMatrix® CanGaroo™ ECM® Envelope 8/26/2014
ArthroSurface Receives FDA Clearance For The KISSloc Hallux Valgus Correction System 8/22/2014
Direct Flow Medical, Inc. Receives CE Mark For 23mm Valve And For Implantation Of All Sizes Of Its Transcatheter Aortic Heart Valve Without Use Of Contrast 8/21/2014
Intuitive Surgical, Inc. (ISRG) Receives Firefly™ FDA Clearance For da Vinci® Xi™ Surgical System 8/21/2014
AliveCor Receives First FDA Clearance To Detect A Serious Heart Condition In An ECG On A Mobile Device 8/21/2014
Immunodiagnostic Systems Chinese FDA Clearance For The IDS-iSYS Instrument 8/21/2014
Celleration, Inc. Announces Next Generation UltraMIST™ System Receives FDA Clearance 8/20/2014
CardiacAssist, Inc. Receives Health Canada Approval For Its PROTEK Duo Veno-Venous Cannula 8/20/2014
FDA Approves First Needle-Free Flu Vaccine Delivery System From PharmaJet 8/19/2014
Oxford Performance Materials Wins FDA Approval For 3D Printed OsteoFab® Patient-Specific Facial Device 8/19/2014
Westmed, Inc. Receives FDA Clearance For The Vibralung® Acoustical Percussor 8/19/2014
Vital Images, Inc. (VTAL) Wins FDA Approval For Image Denoising Software 8/18/2014
FDA Approves XVIVO Perfusion's Donor Lung Preservation Device 8/14/2014
EXACT Sciences Corporation (EXAS) Wins FDA Approval For Cologuard®; First and Only Noninvasive Colorectal Cancer Screening Test 8/12/2014
Cutera, Inc. (CUTR) Wins FDA Clearance For Enlighten™ 8/12/2014
Medtronic, Inc. (MDT) Wins FDA Approval For Attain Performa® Quadripolar Lead And Viva® Quad CRT-Ds 8/7/2014
FDA Green Lights The SynCardia Systems, Inc. Total Artificial Heart With SynHall Valves 8/5/2014
Lombard Medical’s Aorfix™ Receives Regulatory Approval In Japan For Treatment Of Abdominal Aortic Aneurysms 8/5/2014
ElMindA Wins FDA Approval For BNA™ Analysis System 8/4/2014
New York-Based Transluminal Tech Grabs E.U. Win For Bioabsorbable Vascular Closure 8/4/2014
FDA Approves Third Medtronic, Inc. (MDT) Artificial Disc PRESTIGE® LP 8/1/2014
MEDICREA's K-JAWS® Wins FDA Approval In The United States 8/1/2014
K2M Continues Momentum With Complex Spine & Minimally Invasive Line Extensions & Regulatory Clearances 7/31/2014
ZOLL Medical Corporation (ZOLL) Receives Shonin Approval From Japanese Ministry Of Health, Labour And Welfare To Market The R Series Monitor/Defibrillator 7/30/2014
Sorin Group S.p.A. (SRN) Announces FDA Approval Of Solo Smart -- The Next Evolution In Tissue Valve Technology 7/29/2014
Masimo Corporation (MASI) Announces CE Mark And Limited Market Release Of Radius-7™ -- First Rainbow® SET® Noninvasive Wearable, Wireless Monitor For Root® 7/29/2014
Mauna Kea Technologies Receives 510(K) Regulatory Clearance From U.S. FDA For New Cellvizio System Functioning In A Near-Infrared Wavelength 7/29/2014
New Chlamydia And Gonorrhea Assays On The Becton, Dickinson and Company (BDX) Viper™ LT System Receive FDA 510k Clearance 7/28/2014
Quidel Corporation (QDEL) Receives FDA Clearance For Its Hand-Held Molecular Diagnostic Test For Group A Strep 7/28/2014
LabStyle Innovations Receives Israeli Ministry Of Health Approval For The Dario™ Smart Meter 7/28/2014
Syneron Inc. Announces CE Mark For PicoWay Dual Wavelength Picosecond Laser For Tattoo Removal And Treatment Of Pigmented Lesions 7/28/2014
Medtronic, Inc. (MDT) Wins FDA Nod For PRESTIGE® LP Cervical Disc System 7/28/2014
Sorin Group S.p.A. (SRN) Announces CE Mark Approval For CROWN PRT™ Heart Valve 7/24/2014
Royal Philips Electronics N.V. (PHG) Receives FDA 510(K) Clearance For Its Innovative Ultra Mobile VISIQ Ultrasound System 7/24/2014
Boston Scientific Corporation (BSX) Receives CE Mark For Agent™ Drug-Coated Balloon 7/24/2014
Cynosure, Inc. (CYNO) Receives Expanded FDA Clearance to Market PicoSure™ For Treatment Of Acne Scars 7/24/2014
IMRIS Receives CE Mark For Integrating Latest Generation MR Scanners Within VISIUS Surgical Theatre In European Market 7/23/2014
Teleflex Incorporated (TFX) Receives FDA Clearance For ARROW-Clark™ VectorFlow™ Chronic Hemodialysis Catheter 7/23/2014
Veniti Announces FDA Approval Of IDE For VENITI VICI™ Venous Stent System 7/23/2014
CorMatrix Cardiovascular® Reports FDA Clearance Of CorMatrix® ECM® For Vascular Repair 7/22/2014
Varian Medical Systems (VAR) Scores FDA 510(k) Clearance For Calypso 7/22/2014
St. Jude Medical (STJ) Announces CE Mark Approval And First Use Of The Flexability Ablation Catheter 7/22/2014
Boston Scientific Corporation (BSX) Receives FDA Approval For REBEL™ Platinum Chromium Coronary Stent System 7/22/2014
Vittamed Received CE Mark Approval For Non-Invasive Intracranial Pressure Meter And Non-Invasive Cerebrovascular Autoregulation Monitor 7/22/2014
Expanding Orthopedics Inc. Has Obtained FDA Clearance For Its FLXfit™, The World's First 3D Expandable Interbody Cage 7/21/2014
Berry Genomics And Illumina, Inc. (ILMN) Co-Develop Integrated Next-Generation Sequencing System For Review And Approval By Chinese Regulatory Agency 7/21/2014
Rhinomed Wins FDA Approval For Nasal Dilator 7/18/2014
Synergy Biomedical Announces Expanded FDA Clearance Of BIOSPHERE PUTTY For Spine Indications 7/18/2014
Bausch & Lomb Wins FDA Clearance For VICTUS Femtosecond Laser Platform 7/17/2014
FDA Approves The Freedom® Portable Driver That Powers The SynCardia Systems, Inc. Total Artificial Heart 7/16/2014
Boston Scientific Corporation (BSX) Receives CE Mark For The New 25 mm Lotus™ Valve System 7/15/2014
Boston Scientific Corporation (BSX) Receives CE Mark For Ranger™ Drug-Coated Balloon 7/14/2014
Titan Spine Receives FDA Clearance To Launch Endoskeleton® TL Device For Lateral Spinal Fusion 7/14/2014
Natera Achieves CE Mark For Its Cloud-based Analytical Software To Support The Panorama™ Non-invasive Prenatal Test 7/11/2014
Neptune™ Waterproof Cochlear Implant Sound Processor From Advanced Bionics Corporation Receives Approval In China 7/11/2014
Quantel Medical Inc. Wins FDA Nod For Laser Platform Optimis Fusion™ 7/10/2014
Guided Therapeutics, Inc.'s LuViva® Advanced Cervical Scan Awarded Mexican Regulatory Approval 7/10/2014
Dilon Technologies Receives CE Mark Approval For Its Navigator Gamma Probe System 7/10/2014
Neptune™ Waterproof Cochlear Implant Sound Processor From Advanced Bionics Corporation Receives Approval In China 7/10/2014
Merit Medical Systems, Inc. (MMSI) Receives Regulatory Approval For Tracheobronchial Stent Systems In China 7/9/2014
SomnoMed Limited (SOM:ASX) Wins FDA Approval For SomnoDent® Fusion 7/9/2014
NeuroMetrix, Inc. (NURO) Rockets As FDA Approves Pain Treatment For OTC Use 7/8/2014
dorsaVi Release: ViMove Approved For Sale In New Zealand 7/8/2014
FDA Grants Diazyme Laboratories 510(K) Clearance to Market Its Ferritin Assay for Clinical Chemistry Analyzers 7/8/2014
Theradiag Enhances Its Oncology Offer, With An 8th Test In Its Lisa-Tracker Theranostic Range: Avastin® Test Received CE Marking 7/8/2014
Dallen Medical Wins FDA Nod For Disposable Compressyn™ Delivery System 7/7/2014
Ulthera Release: Ultherapy® Décolletage Treatment Now FDA-Cleared 7/7/2014
BGI Diagnostics' NIFTY™ Becomes First CFDA Approved Non-Invasive Prenatal Genetic Test 7/7/2014
Independence Energy Announces Name Change, FDA Clearance And U.S. Launch Of Non-Contact Thermometer 7/2/2014
EarlySense Chair Sensor Receives FDA Clearance 7/2/2014
STAAR Surgical Company (STAA) Grabs CE Mark Approval For Pre-Loaded Visian ICL 7/1/2014
Inova Labs, LLC. Receives FDA Clearance For Activox DUO2™ 7/1/2014
Expanding Orthopedics Inc. Has Obtained CE Mark For Its Unique FLXfit™, 3D Expandable Interbody Cage 7/1/2014
Abaxis, Inc. (ABAX) Announces USDA Approval of VetScan Canine Ehrlichia Antibody Test Kit 7/1/2014
Bayer HealthCare (BAY) Introduces First FDA-Approved Soft Chew In Canine Osteoarthritis Pain Management 7/1/2014
Surgical Theater's Surgical Navigation Advanced Platform Receives FDA Clearance 7/1/2014
Edwards Lifesciences Corporation (EW) Wins FDA Nod For Advanced Noninvasive Monitoring System 6/30/2014
Masimo Corporation (MASI) Wins FDA Nod Of Root™ Patient Monitoring Platform With Capnography, IRIS™ Standalone Device Connectivity, And MOC-9™ Third-Party Measurement Expansion 6/30/2014
SteriWeb Medical Receives FDA OTC Clearance for Resistance Free Antimicrobial Gel 6/30/2014
Thermedx Receives FDA 510(k) For Arthroscopy And Hysteroscopy Fluid Warming 6/30/2014
Inogen (INGN) Wins FDA Approval For Innovative Home Oxygen Concentrator 6/30/2014
FDA Green Lights Argo Medical Technologies' First Robotic Legs To Help The Paralyzed Walk 6/27/2014
Encision, Inc. (ECIA) Wins FDA Approval For Its AEM Endoshield™ Burn Protection System 6/27/2014
FUJIFILM Wins FDA Nod For New Breast Imaging Solution: Aspire Cristalle 6/26/2014
CAS Medical Systems, Inc. (CASM) Receives Regulatory Clearance To Market FORE-SIGHT ELITE® Oximeters In Japan 6/26/2014
Paragon BioTeck Grabs FDA Approval For Comfortear Lacrisolve Absorbable Punctum Plug 6/26/2014
Titan Spine Receives Market Registration Approval In Australia And New Zealand For Its Endoskeleton® Interbody Fusion Devices 6/25/2014
Bruker Corporation MALDI Biotyper™ Receives Clearance As A Medical Device From The China Food And Drug Administration (CFDA) 6/25/2014
FDA Green Lights Nanosphere, Inc.'s Enteric Pathogens Nucleic Acid Test 6/25/2014
Abbott Medical Optics Receives CE Mark For TECNIS® Symfony Extended Range Of Vision Intraocular Lens For Cataract Patients 6/24/2014
Devon Medical Products Wins FDA Nod To Market Its Extricare® 3600 High-Flow Negative Pressure Wound Therapy (NPWT) Pump And Foam Wound Dressing Kit 6/24/2014
BSD Medical (BSDM) Reports Terumo Europe N.V. Obtains Regulatory Approvals for Marketing MicroThermX® Microwave Ablation System in Additional Countries 6/24/2014
Knee And Hip Arthroplasty Device From Orth Align Inc. Wins FDA OK 6/20/2014
QIAGEN N.V. (QGEN) Wins FDA Approval For Artus CMV RGQ MDx Kit 6/19/2014
Solace Therapeutics, Inc. Wins Two FDA Clearances Towards Providing Women An Office-Based Treatment For Stress Urinary Incontinence (SUI). 6/18/2014
AngioDynamics (ANGO) Wins FDA Approval for Celerity Tip Location System 6/18/2014
ERT Receives 510(k) Clearance To Market Its AM3® GSM Devices For Use In Respiratory Clinical Trials 6/17/2014
Edwards Lifesciences Corporation (EW) Wins FDA Approval For New Heart Valve 6/17/2014
Osprey Medical Inc. Receives U.S. FDA Clearance For The AVERT™ System 6/17/2014
Alere Inc. (ALR) Wins FDA Approval For Alere™ i Influenza A And B Test 6/16/2014
Medtronic, Inc. (MDT)'s Heart Valve System Approved For High Risk Patients 6/16/2014
Gynesonics Receives CE Mark on Next Generation VizAblate® System for the Treatment of Symptomatic Uterine Fibroids 6/12/2014
Covidien plc (COV)'s Neurovascular Micro Catheter Wins FDA Approval 6/12/2014
RightBio Metrics Introduces New FDA Cleared Point-Of-Care Devices To Provide Safer, Cleaner And More Accurate Gastric pH Readings 6/11/2014
FDA Green Lights Strativa Pharmaceuticals' Nascobal® (Cyanocobalamin, USP) Nasal Spray Single-Use Device 6/11/2014
Merck Serono Announces FDA Win For Auxogyn, Inc.'s Early Embryo Viability Assessment (Eeva®) System 6/11/2014
Health Canada Approves Roche (RHHBY)'s HPV Test For First-Line Primary Screening Of Cervical Cancer And Roche Launches New Cytology Test To Provide The Most Comprehensive Portfolio For Cervical Cancer Screening 6/11/2014