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Medical Dev. & Diag. - Approvals
Guerbet (GBT) Grabs FDA Nod for the OptiOne Single-Head Contrast Delivery System 2/11/2016
Wenzel Spine Snags FDA Approval to Launch VariLift-LX 2/11/2016
FDA Green Lights MX Orthopedics' Dynamx Compression Staple 2/11/2016
Becton, Dickinson and Company (BDX) Snags FDA Approval for Diagnostic Device for HIV/AIDS 2/10/2016
LifeWatch Wins FDA Approval for Its Continuous Vital Signs Monitoring Service 2/9/2016
CorMatrix Cardiovascular Snags FDA Nod for Its Tyke Implantable Device For Neonate And Infant Cardiac Tissue Repair 2/9/2016
NobleStitch EL Receives Approval In Kazakhstan To Treat PFO And To Suture Cardiac Structures 2/9/2016
AXINESIS Obtains CE Mark For REAplan, Its Medical Interactive Rehabilitation Device 2/8/2016
Atlas Genetics Gains CE Approval For First Product 2/8/2016
Osprey Medical Inc. Receives FDA Clearance for Key DyeVert System Claims 2/8/2016
Medtronic (MDT) First to Win FDA Approval for MR-Conditional Cardiac Resynchronization Therapy-Defibrillators 2/5/2016
Abbott (ABT) Scores CE Mark for Freestyle Libre Flash for Kids 2/5/2016
Bracco Diagnostics Wins First FDA Approval for Barium-Based Product Used for Contrast Radiography 2/2/2016
Dynatronics Corporation (DYNT) Receives Approval To Market SolarisPlus Series In Singapore & Peru 2/1/2016
FDA Green Lights SonarMed's Device for Monitoring Newborns 1/28/2016
Avioq Obtains Health Canada Approval For Screening Of Cadaveric Organ And Tissue Donors With The Avioq HTLV-I/II Microelisa System, Expands Already Approved Health Canada And CE-IVD Claims 1/28/2016
Velano Vascular Receives Additional FDA Clearance for Innovative Blood Draw Device 1/27/2016
Polyganics Receives FDA 510(k) Clearance For Nerve Capping Device NEUROCAP 1/26/2016
Quidel Corporation (QDEL) Receives CE Mark For Its New Sofia Fluorescent Immunoassay For Diagnosis Of Pneumococcal Pneumonia And Pneumococcal Meningitis 1/26/2016
Dako (A) Snags Expanded FDA Approval of Complementary Diagnostic Test to Include Melanoma 1/25/2016
entrotech life sciences Release: ChloraDerm Antimicrobial Transparent Film Dressing Receives FDA Clearance For 7-Day Catheter Site Protection Against MRSA And Other Infection-Related Organisms 1/25/2016
K2M Wins CE Mark for Its Next-Gen RHINE Cervical Disc System 1/22/2016
FDA Clears Intuitive Surgical (ISRG)'s Integrated Table Motion for da Vinci Surgical System 1/22/2016
Pelvalon Wins FDA Nod for Second-Gen Non-Surgical Therapy for Women Suffering from Loss of Bowel Control 1/21/2016
Centinel Spine Announces the FDA Clearance and First Implantation of ALTOS 1/21/2016
Eli Lilly (LLY) Release: FDA Approves Humulin R U-500 Kwikpen 1/21/2016
NeuroMetrix (NURO)'s Peripheral Neuropathy Test Approved for China 1/21/2016
Medicines360 and Camargo Pharmaceutical Services Gain FDA Approval for Intrauterine Contraceptive Device 1/19/2016
W. L. Gore & Associates Release: Unique Biomaterial For Hernia Repair Receives FDA 510K Clearance 1/19/2016
AtriCure (ATRC) Announces Approval For The Atriclip In Japan 1/19/2016
Medical Device Firm Advanced Cooling Therapy Receives 510(K) Clearance From FDA For Second Esophageal Cooling Device To Cool And Warm Patients 1/19/2016
HealthMyne Announces FDA Clearance Of Imaging Analytics Package 1/19/2016
LifeWatch Corp Granted FDA Approval for its Mobile Cardiac Telemetry 1-Lead Patch 1/18/2016
Soterix Medical Launches PainX tDCS Treatment in EU with CE Approval 1/15/2016
Edwards Lifesciences (EW) Receives FDA Approval For Expanded Indication Study Of Sapien 3 Valve 1/15/2016
Olympus (OCPNF) Receives 510(k) Clearance for TJF-Q180V Duodenoscope 1/15/2016
Oculus Innovative Sciences, Inc. (OCLS) Wins CE Mark for New MucoClyns for First Responders 1/14/2016
Imricor Medical Systems Receives CE Mark For MR Compatible Advantage-MR EP Recorder And Stimulator System 1/14/2016
FDA Clears Siemens (SI)’ New High-Volume Coagulation Analyzer 1/13/2016
Medtronic (MDT) Wins FDA Approval for OsteoCool RF Ablation System 1/13/2016
Occlutech Obtains Japanese MHW Approval For Its ASD Occlusion Device 1/12/2016
OptMed Wins FDA Marketing Approval For Its Topical Surgical Skin Adhesive, BondEase 1/12/2016
Aytu BioScience Obtains CE Marking for Company's MiOXSYS System For Male Infertility 1/12/2016
Neovasc (NVC) Receives FDA Approval To Add 40mm Valve Size To The TIARA-I Clinical Trial 1/11/2016
FDA Approves Animas Corporation Vibe Insulin Pump and Continuous Glucose Monitoring System For Use in Children 1/11/2016
Bio2 Technologies, Inc. Announces Receipt of FDA 510(K) Clearance For a Fusion Implant System For Extremities Surgery 1/11/2016
TROD Medical Receives CE Mark Approval For Encage 1/11/2016
Medtronic (MDT) IN.PACT Admiral DEB Receives CE Mark For Treatment Of AV Access In Patients With End-Stage Renal Disease 1/11/2016
Saudi Food And Drug Authority Approves Gamma Medica's LumaGEM Molecular Breast Imaging Solution 1/8/2016
K2M Expands Minimally Invasive Spine Portfolio With Addition Of Its CASCADIA Lateral Interbody System Featuring Lamellar Titanium Technology 1/8/2016
Vivasure Medical Receives CE Mark For First And Only Fully Bioabsorbable Percutaneous Closure Device For Large-Bore Transcatheter Procedures 1/8/2016
MEDTECH Receives FDA Clearance for ROSA Spine 1/6/2016
MST Receives FDA Clearance For "Follow Me" Image-Guided Software For Minimally Invasive Robotic Surgery 1/6/2016
RPS Diagnostics Announces Canadian Approval Of Febridx Test To Help Rapidly Differentiate Viral From Bacterial Acute Respiratory Infection At The Point Of Care 1/6/2016
Vascular Dynamics, Inc. ' MobiusHD System Receives CE Mark For The Treatment Of Resistant Hypertension 1/6/2016
NeuroMetrix (NURO) Announces FDA 510(K) Clearance Of Next Generation Quell® Wearable Pain Relief Technology At The 2016 Consumer Electronics Show 1/6/2016
Bay Area's NuCryo Vascular Wins 510(k) Clearance for Next-Gen Reusable Cryoplasty Inflation Device 1/5/2016
Torax Medical Receives FDA Approval for its FENIX Continence Restoration System to Treat Fecal Incontinence 1/5/2016
iHear Medical Wins Landmark FDA Approval for the First OTC Home Hearing Test 1/4/2016
Soterix Medical Receives CE Mark Approval for 1x1 tDCS Depression Therapy 12/30/2015
FDA Clears FUJIFILM Reprocessing Label For "Superbug"-Susceptible Duodenoscopes 12/30/2015
FDA Approves Torax Medical's FENIX, a Magnetic Bracelet for Fecal Continence Control 12/28/2015
FDA Approves BIOTRONIK Iperia ICD Systems With Full-Body ProMRI Technology 12/22/2015
Bio-Rad (BIO)'s TANGO infinity Receives FDA 510(k) Clearance for U.S. Markets 12/22/2015
LabStyle Innovations Receives U.S. FDA Marketing Clearance For the Dario Blood Glucose Monitoring System 12/22/2015
Bio Light's IOPtiMate System Receives Regulatory Approval In Canada 12/21/2015
Roche (RHHBY) Receives FDA Approval For HIV-1 Viral Load Test on the cobas 6800/8800 Systems 12/21/2015
Instrumentation Laboratory Company Receives US FDA Clearance For New ACL TOP Family 50 Series Hemostasis Testing Systems 12/21/2015
DeGen Medical Receives Clearance of Latitude-C Cervical Interbody Spacer System 12/21/2015
Thermo Fisher Scientific (TMO) Receives FDA Clearance For New Allergen Component Tests For Hazelnut, Walnut And Cashew Nut IgE Sensitization 12/21/2015
Luminex (LMNX) Snags FDA Approval for NxTAG Respiratory Pathogen Panel 12/18/2015
GI Logic Grabs FDA Approval for the AbStats System for Real-Time Digestive Telemetry 12/18/2015
FDA Approves ZOLL (ZOLL)'s Wearable Defibrillator for Kids 12/18/2015
Bio-Rad (BIO) Wins FDA Approval for Its D-100 System for A1c Testing 12/17/2015
Empire Genomics Obtains CE Marking 12/17/2015
REGENSCIENTIFIC Receives CE-Mark For Its Renú Injectable Implant In The European Union 12/16/2015
K2M Grabs FDA Approval for EVEREST Minimally Invasive XT Spinal System 12/16/2015
Svelte Medical Snags CE Mark Certification of SLENDER IDS 12/15/2015
BTG plc (BTG.L) Wins FDA Approval for LC Bead LUMI, the First Commercially Available Radiopaque Embolic Bead in the U.S. 12/14/2015
Theradiag Expands Its Biotherapy Monitoring Range, With A New CE Marking Obtained For Its Entyvio Test 12/14/2015
RevMedx's Device That Plugs Gunshot Wounds in 20 Seconds Just Got FDA Approval 12/11/2015
EDAP TMS (EDAP) Receives Russian Regulatory Approval For Focal One HIFU Device 12/11/2015
Endologix AFX Endovascular AAA System Receives Shonin Approval For Marketing In Japan 12/11/2015
Medtronic (MDT) Announces FDA Approval Of Infuse Bone Graft For Three New Spine Surgery Indications 12/11/2015
CareFusion Wins Approval for Two Spine Products 12/10/2015
CMS Approves Transitional Pass-Through Payment For Outpatient Use Of Nevro's Senza Spinal Cord Stimulation System 12/10/2015
Neogen Corporation (NEOG)'s ANSR For E. Coli O157:H7 Receives AOAC Approval 12/10/2015
Medtronic (MDT) Wins Approval for the Only Full-Body MR Conditional DBS 12/9/2015
Stimwave Wins FDA Nod and Launches Commercialization for World’s Smallest Fully-Programmable, Eight-Electrode Wireless Pain Relief SCS System 12/9/2015
Mauna Kea Technologies Receives New Regulatory Approval For Cellvizio 100s In China 12/9/2015
Neogen Corporation (NEOG)'s ANSR For E. coli O157:H7 Receives AOAC Approval 12/9/2015
Cerus (CERS) Announces Agência Nacional De Vigilância Sanitária Approval Of The INTERCEPT Blood System For Platelets And Plasma In Brazil 12/9/2015
Royal DSM Receives FDA 510k Clearance For Dyneema Purity Radiopaque Cerclage Cable For Use In Orthopedic Trauma 12/8/2015
Cepheid (CPHD) Receives FDA CLIA Waiver For Xpert Flu+RSV Xpress Test 12/7/2015
InspireMD Ltd. Receives EU Regulatory Approval for Additional Supplier Of CGuard Delivery Catheters 12/3/2015
St. Jude Medical (STJ) Wins CE Mark for MRI Compatibility on Quadra Assura CRT-D to Improve Access to Diagnostic Imaging for Heart Failure Patients 12/2/2015
FDA Green Lights Philosys' Android for Gmate SMART Mobile Diabetes Monitoring System 12/2/2015
EndoStim's Neurostimulation Therapy For Gastroesophageal Reflux Disease Approved In Brazil 12/2/2015
Greatbatch (GB) Receives FDA Approval of Algovita Spinal Cord Stimulation System 12/1/2015
Boston Scientific (BSX) Receives FDA Approval And CE Mark For AngioJet ZelanteDVT Thrombectomy Catheter 12/1/2015
Caputron Medical Announces FDA Cleared Mindgear Treatment For Depression, Insomnia And Anxiety 12/1/2015
Oticon Medical Gains FDA Clearance For Two New Offerings: Minimally Invasive Ponto Surgery (MIPS) And Ponto BHX Implant 12/1/2015
Siemens (SI) Wins FDA Approval for Multitom Rax Robotic X-ray System 11/30/2015
FDA Green Lights St. Jude Medical (STJ)'s Proclaim Elite Spinal Cord Stimulator for Chronic Pain 11/30/2015
Covalon Technologies Ltd. Snags FDA Approval for Its New SilverCoat Silicone Foley Catheter 11/30/2015
Elbit Imaging Ltd. (EMITF) Announces That InSightec's Exablate Neuro System Has Been Approved By The Korean Ministry Of Food And Drug Safety 11/30/2015
XENIOS AG Grabs CE Mark for Its i-cor Synchronized Cardiac Assist System 11/25/2015
EDDA Technology Wins FDA Approval for IQQA-Guide 11/25/2015
Entellus Medical (ENTL) Snags FDA Approval for XprESS Multi-Sinus Dilation System in Pediatric Patients 11/24/2015
Boston Scientific (BSX) Grabs CE Mark For Next Generation WATCHMAN FLX Left Atrial Appendage Closure Device 11/20/2015
Visunex Medical Wins FDA Approval for Revolutionary Imaging Device for Vision Screening of All Newborn Infants 11/19/2015
St. Jude Medical (STJ) Announces FDA Approval Of The Proclaim Elite SCS System, A Patient-Centric, Recharge-Free, Upgradeable And MR-Conditional Chronic Pain Treatment Option 11/19/2015
Moximed Wins CE Mark and First Commercial Use of AtlasTM Knee System 11/18/2015
Medtronic (MDT) Wins FDA Nod and Launches World's First App-Based Remote Monitoring System for Pacemakers 11/17/2015
Vigilant Biosciences Snags CE Mark for OncAlert Oral Cancer CD44/Total Protein LAB Test to Aid in Diagnosis of Oral Cancer 11/16/2015
Mallinckrodt Pharmaceuticals Receives FDA Clearance For INOmax DS(IR) Plus MRI Device 11/16/2015
NeuroSigma's Monarch eTNS System Receives CE Mark Approval for ADHD 11/16/2015
Innovacyn Inc. Release: Puracyn Plus Professional Formula Approved In Canada As Class II Medical Device 11/16/2015
Spectranetics (SPNC) Wins FDA Approval of Turbo-Power Laser Atherectomy Catheter 11/13/2015
Roche (RHHBY) Receives FDA Approval For cobas EGFR Mutation Test V2 As A Companion Diagnostic For Non-Small Cell Lung Cancer Therapies 11/13/2015
Perspectum Diagnostics Announces FDA Clearance for LiverMultiscan MR Imaging Device 11/12/2015
Cephasonics Receives CE Mark Approval for cQuest Cicada Ultrasound Subsystem 11/12/2015
Interventional Spine Gains FDA Clearance Of Advanced Design Of Its Expandable Opticage For Spinal Fusion 11/10/2015
KATOR Receives FDA 510(k) For Suture Anchor System 11/10/2015
FDA Approves InnFocus Glaucoma Study Expansion 11/10/2015
SI-BONE's iFuse Implant System Receives Indication Cleared by the FDA 11/9/2015
EDAP TMS (EDAP) Snags FDA Approval for Ablatherm HIFU 11/9/2015
Syneron Candela Snags New FDA Approval for the CO2RE System 11/5/2015
Convergent Dental Wins FDA Clearance of Osseous Tissue Procedures for Solea 11/5/2015
Renal Dynamics Release: Third-Generation Renal Denervation System By Redy Received European Regulatory Approval 11/5/2015
Akers Biosciences, Inc.' Flagship Test For Heparin-Induced Thrombocytopenia Granted Approval By Chinese Food And Drug Administration 11/4/2015
Reflexion Health Digital Medicine Therapy Tool, Vera, Receives FDA 510(K) Clearance 11/4/2015
CeraPedics Wins FDA Approval for i-FACTOR Peptide Enhanced Bone Graft in Cervical Spine Surgery 11/4/2015
INVO Bioscience Receives FDA Clearance for INVOcell Fertility Treatment 11/4/2015
Implanet Release: ANVISA Regulatory Approval Granted In Brazil To Market The JAZZ Band Platform 11/3/2015
China Food And Drug Administration (CFDA) Grants Approval For Avedro, Inc.'s KXL System 11/3/2015
Organogenesis Inc. Release: Apligraf Wound Healing Technology Becomes First Transplant Product To Receive Marketing Approval In Switzerland 11/2/2015
Mainstay Medical (MSTY.PA) Applies For CE Mark For ReActiv8 11/2/2015
Integra LifeSciences (IART) Wins Expanded Indication for CUSA Excel+ System for Liver Surgery 10/30/2015
Mauna Kea Technologies Awarded U.S. FDA Clearance for use of Cellvizio in Minimally Invasive Surgery 10/28/2015
AV Medical Tech Snags FDA Approval for its Chameleon Angioplasty Balloon Catheter 10/27/2015
Thermo Fisher Scientific (TMO) Release: New Immunoassay For The Specific Detection Of Hydrocodone Receives FDA 510 (K) Clearance 10/27/2015
Masimo (MASI) Announces FDA 510(K) Clearance For Mightysat Rx Fingertip Pulse Oximeter 10/27/2015
Pryor Medical Devices Nabs FDA Nod For Distribution Of Its ER-REBOA Catheter 10/26/2015
Vermillion Announces CE Mark for Overa, the Next Generation OVA1 Test 10/26/2015
C2 Therapeutics' Wins CE Mark for Novel Cryoablation Device 10/22/2015
Qualcomm's Capsule Receives FDA Clearance of SmartLinx Vitals Plus 10/21/2015
Fresenius Kabi AG and Verax Biomedical Release: FDA Clearances Allow Implementation Of 7-Day Platelets In The U.S. With The Platelet PGD Test 10/21/2015
Moleculight Announces Health Canada Approval For The MolecuLight i:X, Its First Diagnostic Medical Imaging Device For Wound Care 10/21/2015
Cepheid (CPHD) Receives FDA Clearance For Xpert TV, The First On-Demand Test For Same Day Consultation And Treatment Of Trichomonas Vaginalis Infection 10/21/2015
Medtronic (MDT) Receives CE Mark for New Single-Chamber ICDs That Can Detect Atrial Fibrillation 10/21/2015
EndoStim Receives CE Mark For Full Body MRI Use With EndoStim II LES Stimulation System 10/20/2015
RenovoRx Receives CE Mark for RenovoCath 10/20/2015
LDR (LDRH) Secures Expanded Indication For ROI-C Cervical Cage 10/20/2015
Sensus Healthcare Receives FDA 510k Clearance For Next Generation Image Guided Superficial Radiotherapy SRT-100 Vision 10/19/2015
Lightpoint Medical Obtains CE Mark Approval for the LightPath Imaging System, the World's First Approved Intra-Operative Molecular Imaging Device 10/19/2015
ViewRay Receives Regulatory Approval To Sell MRI-Guided Radiation Therapy System In Korea 10/19/2015
Biophor Diagnostics, Inc. Announces Seventh FDA 510(K) Clearance, Completing Panel Of Rapid, Homogeneous Screening Tests For Drugs Of Abuse In Oral Fluid 10/19/2015
Luminex (LMNX) Receives CE-IVD Mark For Respiratory Pathogen Panel 10/19/2015
Roche (RHHBY) Receives FDA Approval For Viral Load Tests And Cobas 6800/8800 Systems 10/19/2015
InSpire MD Announces CGuard Approval In Argentina 10/19/2015
Orfit Announces CE And FDA Clearance For "HP PRO SOLUTION" Proton Therapy Immobilization System 10/16/2015
Simplify Cervical Artificial Disc Receives Two-Level IDE Approval 10/16/2015
Edwards Lifesciences (EW) SAPIEN XT Valve Receives FDA Approval For Aortic Valve-In-Valve Procedures 10/16/2015
Avinger Nabs FDA 510(k) Clearance for Pantheris 10/15/2015
Ortho Clinical Diagnostics Receives CE Mark Clearance for ORTHO VISION Max Analyzer for High-Volume Transfusion Medicine Labs 10/14/2015
FDA Approves SonaCare Medical's Sonablate High Intensity Focused Ultrasound Prostate Ablation Device 10/14/2015
Baxter International (BAX) Announces FDA Clearance For AMIA Automated Peritoneal Dialysis System With SHARESOURCE Connectivity Platform 10/13/2015
Safe Orthopaedics Obtains FDA Approval To Market Its Unique Implant For Spinal Trauma Care In The United States 10/13/2015
Gamma Medica Receives CE Mark for LumaGEM Molecular Breast Imaging System, a New Standard of Care in Breast Imaging 10/12/2015
St. Jude Medical (STJ) Announces CE Mark Approval For The HeartMate 3 Left Ventricular Assist System 10/12/2015
Varian Medical Systems (VAR) Receives CE Mark For Its Latest ProBeam Proton Therapy System 10/12/2015
NuVasive (NUVA) Wins First Ever FDA 510(k) Clearance of Cervical Corpectomy Cage 10/12/2015
Endologix Announces FDA Approval Of AFX2 Bifurcated Endograft System 10/12/2015
Sequent Medical Inc. Announces Approval To Utilize Latest Generation WEB Devices In U.S. IDE Study 10/12/2015
Dako (A), An Agilent (A) Company, Announces FDA Approval Of New Test For Lung Cancer Patients 10/12/2015
FDA Green Lights InSightec's Next-Gen Noninvasive Ultrasound Fibroid Device Exablate 10/8/2015
SentreHEART Receives CE Mark Approval For The LARIAT Surgical Left Atrial Appendage Suture Delivery Device 10/8/2015
Carestream Health Obtains FDA Clearance For Diagnostic Reading Of ECG Waveforms On Mobile Tablets Using Vue Motion Viewer 10/8/2015
Avita Medical Snags CE Mark for ReGenerCell and ReNovaCell to Complete Skin Healing Portfolio 10/7/2015
Luminex (LMNX) Nabs FDA Nod for ARIES System and ARIES HSV 1&2 Assay 10/7/2015
FDA Approves InSightec's Next Generation Exablate Fibroid Treatment System And Removes Requirement For Patients To Be Family Complete 10/7/2015
Varian Medical Systems (VAR) Wins FDA Approval and CE Mark for VitalBeam Package 10/7/2015
Vertera Spine Announces FDA Clearance of the First Surface Porous PEEK Interbody Fusion Device 10/6/2015
Quest Diagnostics (DGX) Release: FDA Clears The Focus Diagnostics Simplexa Flu A/B & RSV Direct Test To Include 53 New Virus Strains For The 2015-2016 Flu Season 10/6/2015
NovoCure Release: FDA Approves Optune In Combination With Temozolomide For The Treatment Of Newly Diagnosed Glioblastoma 10/6/2015
FDA Clears Corindus Vascular Robotics's CorPath System for Robotic-assisted Radial Access PCI Procedures 10/6/2015
Hitachi Medical Systems America Announces FDA Clearance of High-Value Supria 16-Slice CT System 10/6/2015
Boston Scientific (BSX) Wins FDA Nod for SYNERGY Bioabsorbable Polymer Drug-Eluting Stent System 10/5/2015
NovoCure Grabs CE Mark and First Patient Use of Second Generation Optune System 10/5/2015
Dako (A) Snags FDA Approval of New Companion Diagnostic for Lung Cancer 10/5/2015
Bay Area's EBR Systems Wins CE Mark Approval for World’s First Wireless Cardiac Pacing System for Heart Failure 10/5/2015
Irvine Scientific Receives CE Mark Approval For Human Serum Albumin 10/5/2015
Hospi Corporation (PRXL) Receives European Regulatory Approval For Novel Medication Administration Device 10/1/2015
SpineGuard Receives CE Mark For New Application Of Its Disruptive DSG (Dynamic Surgical Guidance) Platform 9/30/2015
UVLrx Therapeutics Wins CE Marking for Intravenous UV Light Therapy Device 9/29/2015
Occlutech Obtains European CE Approval For Its Novel mVSD Device 9/29/2015
UVLrx Therapeutics Receives CE Marking For Intravenous UV Light Therapy Device 9/29/2015
Stentys Receives CE Mark For Self-Apposing Stent In Lower Limb Artery Disease 9/29/2015
iNeedMD Gains CFDA Approval For EKG Medical Device 9/29/2015