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Medical Dev. & Diag. - Approvals
SuperSonic Imagine Announces Regulatory Clearance Of The Next-Generation Aixplorer Ultrasound System In Japan 5/29/2015
SurgiQuest's AirSeal® System Snags FDA 510(k) Clearance for Transanal Endoscopic Surgery 5/28/2015
tosense Wins FDA Approval for Heart Monitoring Necklace 5/28/2015
InvisionHeart Grabs FDA Approval for its InvisionECG Technology 5/27/2015
EOS Imaging Grabs CE Mark for kneeEOS, the first 3D Stereo-Radiographic Planning Software for Total Knee Arthroplasty 5/27/2015
RegenScientific Announces FDA-Clearance Of Its Renu Gel Injectable Implant 5/27/2015
Penumbra, Inc. ACE64 Cleared For Marketing By FDA For Acute Ischemic Stroke Patients 5/27/2015
Thoratec Corporation (THOR) Receives Conditional FDA Approval For The Shield II U.S. Clinical Trial For HeartMate PHP 5/26/2015
VertiFlex Announces FDA PMA Approval For The Superion Interspinous Spacer 5/26/2015
Roche (RHHBY) Snags FDA Approval for the Cobas Cdiff Test 5/26/2015
Verax Biomedical, Incorporated Gains FDA Clearance For Expanded Platelet Safety Measure Testing Indications 5/26/2015
Seegene Receives CE Mark For First Comprehensive Real-time PCR Gastrointestinal Infection Panels 5/26/2015
B.Braun Medical Wins FDA Nod to Offer Broad Spectrum Intravenous Antibiotic-Meropenem, in Its Innovative DUPLEX Container 5/20/2015
Emmes Announces FDA Clearance of New Medical Device 5/20/2015
Abbott (ABT) Announces CE Mark For New Advancement Of Absorb Stent System For People With Heart Disease 5/19/2015
BrainScope Company, Inc.’s Ahead 200 Device Cleared By FDA For Adjunctive Assessment Of Traumatic Brain Injury 5/19/2015
Cynosure (CYNO) Nabs FDA Approval for SculpSure, the World's First Hyperthermic Laser Treatment for Non-Invasive Fat Reduction 5/19/2015
Cleveland HeartLab Receives Internationally Recognized Quality Designation ISO 13485 And Achieves CE Mark For New Universal MPO Assay; Opening New Global Markets For Valuable And Proprietary MPO Testing 5/19/2015
Implanet: CE Mark And FDA Clearance In The United States For New JAZZ Diameters 5/19/2015
Nitiloop Wins FDA Approval for its NovaCross Microcatheter 5/18/2015
Arterial Remodeling Technologies (ART) Announces CE Mark Clearance For Its Pure Bioresorbable Scaffold 5/18/2015
Mauna Kea Technologies Announces CE Mark For Use Of Cellvizio In Minimally Invasive Surgery 5/18/2015
St. Jude Medical (STJ) Expands Portfolio Of MRI-Compatible Devices To High Voltage In Europe 5/13/2015
Becton, Dickinson and Company (BDX) Wins FDA Approval for a Novel Infusion Set With BD Flowsmart Technology 5/13/2015
Aethlon Medical (AEMD) Announces Health Canada Approval Of Ebola Treatment Protocol 5/13/2015
Ablative Solutions Announces CE Mark Of The Peregrine System Infusion Catheter 5/13/2015
COPAN Is Proud To Announce FDA Clearance For FecalSwab To Standardize And Simplify Enteric Culture And Molecular Diagnostics 5/13/2015
Medtronic (MDT) Wins FDA Nod and CE Mark for Arctic Front Advance ST Cryoballoon 5/12/2015
Genesys Spine Earns ISO Certifications, CE Mark 5/12/2015
Aethlon Medical (AEMD) Announces Institutional Review Board Approval of Multi-Indication Cancer Study 5/12/2015
Nevro Snaps Up FDA Approval for Senza Spinal Cord Stimulation System 5/11/2015
Roche (RHHBY) Wins FDA Approval for cobas KRAS Mutation Test 5/11/2015
Surefire Medical, Inc.’s New Precision Infusion System For Embolization Procedures Receives CE Mark Approval 5/8/2015
Medtronic (MDT) Grabs FDA Approval and Launches Euphora Semicompliant Coronary Balloon in the U.S. 5/5/2015
FDA Clears Invictus Medical’s GELShield for Market Launch 5/4/2015
Yolo Medical Wins FDA Approval for Body Contouring Laser 5/4/2015
Medtronic Neurosurgery Receives Expanded Indications For The StealthStation Electromagnetic Surgical Navigation Technology 5/4/2015
AxoGen, Inc. (AXGN) Announces Clearance From FDA To Proceed With New Multicenter Comparative Study For Avance Nerve Graft 5/4/2015
Medtronic (MDT) Snags FDA Approval for ZEVO Anterior Cervical Plate System 5/4/2015
Sonendo Receives 510(K) FDA Clearance For Its Multisonic Ultracleaning System 5/4/2015
St. Jude Medical (STJ) Wins FDA Approval for World’s Smallest Upgradeable MR-Conditional Spinal Cord Stimulation System 5/1/2015
BoneSupport Wins CE-Mark of CERAMENT|V 4/29/2015
Stentys’ Next-Generation Of Self-Apposing Stent System Receives CE Marking Ahead Of Plan 4/29/2015
Strauss Surgical Announces Health Canada Regulatory Approval Of The Strauss Optiks HD Endoscopes 4/28/2015
Ortho-Clinical Diagnostics Receives Health Canada Approval For ORTHO VISION Analyzer 4/28/2015
Biosure Launches World's First HIV Self-Testing Kit 4/27/2015
InSpire MD Announces MGuard Prime Approval In Brazil 4/27/2015
Avita Medical Snags CE Mark for Expanded ReCell 4/27/2015
Oxford Immunotec Limited (OXFD) Announces CE Mark Approval for T-SPOT.CMV Test 4/27/2015
FH Ortho Receives FDA 510(K) Clearance For Its Arrow Reverse Shoulder Long Keel & Short Keel Glenoid Base 4/27/2015
Vital Art and Science, LLC (VAS) Release: First FDA Cleared Ophthalmic App For Monitoring AMD And DR 4/27/2015
Avita Medical Granted CE Mark For Expanded ReCell 4/27/2015
Nipro Diagnostics Grabs FDA Approval for TRUE METRIX AIR 4/24/2015
Pressure Point Inc. Receives Chinese FDA Approval For Its U.S.A Made Pressure Right Nausea Treatment Device And Enters Into Trade Agreement 4/24/2015
Elekta CE Marks For Monaco V5.10 Treatment Planning System 4/24/2015
FDA Green Lights Siemens (SI)' Breast Tomo Device 4/23/2015
Coloplast (COLOB.CO)'s Penile Prosthesis Approved for Ectopic Placement 4/23/2015
Clear Guide Medical Receives CE Mark On The Clear Guide ONE 4/23/2015
Great Basin Scientific Wins FDA 510(k) Approval for Group B Strep Molecular Diagnostic Test 4/22/2015
Natus Medical Incorporated (BABY) Snags 510(k) FDA Approval for Quantum High Channel Count Amplifier 4/21/2015
Alcyone Lifesciences (PRCT) Receives FDA Clearance for MRI-Compatible MEMS Cannula 4/21/2015
Cardiovascular Systems Snags FDA Approval for New Peripheral Diamondback Device 4/20/2015
FDA Approves AcuFocus' First-of-Its-Kind Corneal Implant 4/20/2015
Deka Medical Receives Additional FDA Clearance For The Synchro REPLA:Y Family Of Laser Systems, For Increased Power And Larger Spot Size. 4/20/2015
Syneron Candela's PicoWay Picosecond Laser Receives U.S. FDA Clearance For Treatment Of Pigmented Lesions 4/20/2015
BIOTRONIK SE & Co.KG Release: FDA Approves Only ICD With Ultra-High Energy On The First Shock 4/17/2015
Cepheid (CPHD) And FIND Announce European Approval Of Xpert HIV-1 Qual 4/16/2015
Moirai Orthopaedics Release: PIR Knee System Receives FDA Approval To Initiate IDE Clinical Study 4/16/2015
Applied Spectral Imaging (ASI) Received South Korean Ministry Of Food And Drug Safety (MFDS) Clearance For Genasis Hipath IHC Family For HER2, ER, PR And Ki67 4/16/2015
CAS Medical Systems, Inc. (CASM) Wins FDA Approval for FORE-SIGHT ELITE in Pediatric and Neonatal Patients 4/15/2015
Conventus Orthopaetics Receives FDA Clearance For PH Cage, Proximal Humerus Implant Device 4/15/2015
FDA Clears The Simplexa Group A Strep Direct Test From Focus Diagnostics, A Quest Diagnostics (DGX) Business 4/15/2015
Hansen Medical (HNSN) Receives CE Mark for Magellan 10Fr Robotic Catheter 4/15/2015
Cepheid (CPHD) Announces European Approval Of Xpert HCV Viral Load 4/15/2015
Eyenuk, Inc. Granted CE Marking For EyeArt Automated High-Throughput Diabetic Retinopathy Screening 4/14/2015
Waters Corporation (WAT) UPLC I-Class/Xevo TQ-S System Approved For In Vitro Diagnostic Use In China 4/14/2015
Medtronic (MDT) Announces CE Mark of World's Smallest Pacemaker, Micra Transcatheter Pacing System 4/14/2015
Perseon Announces FDA Clearance for Specific Indication of Non-Resectable Liver Tumor Ablation 4/14/2015
INOVA Diagnostics, Inc. Release: NOVA View Automated Digital IFA Microscope Receives INOVA Diagnostics, Inc. de Novo Clearance 4/13/2015
HeartWare International Receives Health Canada Approval For Commercialization Of The HeartWare Ventricular Assist System As A Bridge To Heart Transplantation 4/9/2015
ivWatch Receives FDA Clearance And Significantly Advances Safety Of IV Therapy 4/9/2015
Perseon's MicroThermX Receives FDA Clearance for Laparoscopic Ablation Procedures 4/8/2015
Mobidiag Announces CE Mark Approval For Clostridium Difficile Infection And Hypervirulent 027 Ribotype Test 4/8/2015
FDA Expands Indication for EVARREST Fibrin Sealant Patch 4/6/2015
On-X Life Technologies, Inc. Release: FDA Approval: On-X Aortic Valves With Less Warfarin 4/6/2015
Ethicon, Inc. (JNJ) Release: FDA Expands Indication For EVARREST Fibrin Sealant Patch 4/6/2015
Bruker BioSciences Corporation (BRKR) Snags FDA Approval for Second, Expanded Claim for the MALDI Biotyper CA System 4/3/2015
Alere (ALR) Receives FDA Clearance for Alere i Strep A Rapid Molecular Test 4/2/2015
Thoratec Corporation (THOR) Receives Approval From FDA For Full Expansion Of HeartMate III U.S. IDE Clinical Trial 4/2/2015
Augmenix Announces FDA Clearance Of SpaceOAR System 4/2/2015
Proven Process Client Flowonix Achieves FDA PMA(S) Approval Of Prometra II Infusion Device 4/2/2015
Teva (TEVA) Announces FDA Approval of ProAir RespiClick 4/1/2015
AirStrip Sense4Baby System Receives FDA Clearance for Patient Self-Administration 4/1/2015
Baxter International (BAX) Completes CE Mark Approval for HOMECHOICE CLARIA Automated Peritoneal Dialysis System with SHARESOURCE 4/1/2015
Pelvalon Announces Clinical Data from Original Proof-of-Concept Study for Eclipse, the First Vaginal Device for Bowel Control 4/1/2015
Medtronic (MDT) CoreValve System Receives FDA Approval for Transcatheter Valve-In-Valve Procedures 3/31/2015
FDA Approves Investigational Study For New Smaller SynCardia Systems, Inc. Total Artificial Heart 3/31/2015
PlasmaTech Biopharmaceuticals' Partner Hanmi Pharma Receives Marketing Approval For MuGard In Korea 3/31/2015
Berry Genomics NextSeq CN500 Instrument And Non-Invasive Prenatal Testing Reagent Kit Receives Chinese FDA Premarket Clearance 3/31/2015
Medtronic (MDT) Announces Japanese Regulatory Approval Of CoreValve System 3/30/2015
Stryker Spine Receives FDA Clearance For New Lumbar Plating System 3/26/2015
Wright Medical Group, Inc. (WMGI) Wins FDA Nod For Salvation External Fixation Device 3/26/2015
New Bay Area Startup EchoPixel Launches; Snags FDA Approval for True3D Viewer 3/25/2015
Theradiag Receives CE Marking For Its 10th Biotherapy Monitoring Test 3/25/2015
Flow-Fx's Flow-Screw Wins FDA Approval 3/24/2015
Critical Diagnostics Gains China Approval For Heart Risk Assay 3/24/2015
FDA Green Lights Abiomed (ABMD)'s Blood Pump Device 3/24/2015
NovaBone Products Wins FDA Approval for Wound Dressing 3/23/2015
Vascular Pathways Snags FDA Approval for AccuCath Midline Catheter System 3/20/2015
Cutera, Inc. (CUTR) Announces Korean Clearance Of Enlighten 3/20/2015
FDA Approves BIOTRONIK SE & Co.KG Eluna Pacemaker System With Full-Body ProMRI Technology 3/20/2015
Semler Scientific Announces FDA Clearance For Next Generation PAD Testing System 3/19/2015
Silver Bullet Therapeutics Announces CE Mark Approval For The OrthoFuzIon Cannulated Bone Screw System 3/19/2015
Analytica Release: Pericoach System Receives 510(K) Clearance In USA 3/19/2015
CorMatrix Cardiovascular CanGaroo Secures International Approval For South America 3/19/2015
Boston Scientific (BSX) Snags FDA And CE Mark Approval Of The EMBLEM S-ICD System 3/18/2015
Simplify Cervical Artificial Disc Receives IDE Approval 3/18/2015
FDA Approves Boston Scientific (BSX)'s Watchman Device 3/17/2015
Quidel Corporation (QDEL) Receives FDA Clearance For Its Amplivue Trichomonas Assay: A Hand-Held Molecular Diagnostic Test For Trichomoniasis 3/17/2015
Vucomp Announces FDA Approval Of M-Vu Computer-Aided Detection (CAD) For Mammography Version 3.2 3/16/2015
Toshiba America Medical Systems’s Infinix 4DCT Scores FDA Approval With Aquilion PRIME CT Configuration 3/13/2015
Lombard Medical Technologies (LMT.L) Receives Regulatory Approval In Japan For Aorflex Endovascular Stent Graft Delivery System 3/13/2015
Volcano Corporation Snags CE Mark For iFR Scout Pullback Software 3/12/2015
Theradiag Strengthens Its Positioning In The Oncology Theranostics Market With Its Herceptin Monitoring Test Receiving CE Marking 3/12/2015
JustRight Surgical Receives CE Mark Approval for Miniature Surgical Instruments Used in Pediatric Surgery, Other Delicate Procedures 3/12/2015
Tornier Scores FDA Approval of Simpliciti Shoulder System 3/11/2015
Vexim Obtains CE Approval To Market Masterflow Injection System In Europe 3/11/2015
Sleep Specialists, LLC Receives Regulatory Approval In Australia For Zzoma Sleep Apnea Device 3/10/2015
Somna Therapeutics Release: FDA Clearance for REZA BAND UES Assist Device that Reduces Symptoms of Laryngopharyngeal Reflux (LPR) 3/10/2015
FDA Approves Kaneka Corporation (KANKF.PK )'s Lixelle Dialysis Device 3/10/2015
TomTec Imaging Systems GmbH Receives FDA 510(K) Clearance For Its Latest Version Of Tomtec-Arena Software 3/9/2015
Aerocrine Grabs FDA Approval for NIOX VERO BlueTooth Wireless Enhancement 3/6/2015
Abaxis, Inc. (ABAX) Announces USDA Clearance Of VetScan Anaplasma Rapid Test 3/6/2015
Life Spine Announces FDA Clearance Of Forty Transition Connector Implants To Thoracolumbar And Cervical Systems 3/5/2015
joimax Receives 510(k) Clearance For Percusys Pedicle Screw-Rod System 3/4/2015
Actavis (ACT) Hormonal Contraceptive Device Wins FDA Approval 3/2/2015
Alere (ALR) Receives IVD CE Mark For Alere Q HIV-1/2 Detect Assay For Molecular Diagnosis Of HIV At The Point Of Care 3/2/2015
Electrical Geodesics, Inc. IDE Clearance From FDA To Commence Feasibility Clinical Trials For GTEN In Epilepsy 3/2/2015
Seegene, Inc. Receives Health Canada Approval For Its New Allplex Respiratory Molecular Test 3/2/2015
BioFire Diagnostics, Inc Receives FDA Clearance for the FilmArray 2.0 System 2/27/2015
FDA Approves Allergan (AGN)’s NATRELLE INSPIRA Round Gel-Filled Breast Implants 2/27/2015
Noxilizer RTS Series NO2 Sterilizers Approved For CE Mark Under The Medical Device Directive 2/27/2015
Cyberonics (CYBX) Announces CE Mark Approval of the VITARIA System for Treatment of Chronic Heart Failure 2/26/2015
Corgenix Medical Corporation (CONX) Receives FDA Authorization And WHO Listing For Emergency Use Of Ebola Rapid Diagnostic Test 2/26/2015
Meridian Bioscience, Inc. (VIVO) Bioscience Receives CE Marking For Two New Molecular Amplification Tests: Illumigene® Chlamydia And Illumigene Gonorrhea 2/26/2015
23andMe Wins FDA Approval for First Genetic Test Kit 2/26/2015
BoneSupport Receives Approval To Market CERAMENT In India 2/25/2015
NOVACYT Receives Approval In China For Novaprep 2/25/2015
bioLytical™ Laboratories's INSTI HIV Assay Receives FDA Approval For HIV-2 2/24/2015
Bioness Inc. Announces FDA 510K Clearance Of Stimrouter® System; A Novel, Implantable Neuromodulation Device Designed To Treat Chronic Peripheral Pain 2/24/2015
Second Sight Announces First Commercial Implants Of The Argus II Retinal Prosthesis System In France 2/24/2015
Cynosure, Inc. (CYNO) Announces FDA Clearance of New 532 nm Laser Delivery System for PicoSure 2/24/2015
Medtronic, Inc. (MDT)'s Varicose Veins Device Wins FDA Approval 2/23/2015
23andMe Granted Authorization By FDA To Market First Direct-To-Consumer Genetic Test Under Regulatory Pathway For Novel Devices 2/20/2015
Neuronetrix, Inc. Wins FDA Nod To Market COGNISION 2/20/2015
Seegene, Inc. Grabs FDA Approval for Its Herpes Simplex Virus Molecular Test 2/17/2015
Simplify Medical Announces CE Mark For New MRI Compatible Cervical Artificial Disc 2/17/2015
Dallen Medical Wins FDA Approval for New Tensyn Plug 2/17/2015
Neuronetrix, Inc. Wins FDA Approval for Brain-Scan Device 2/16/2015
Medtronic, Inc. (MDT) Snags CE Mark and European Launch of Euphora Semicompliant Coronary Balloon Catheter 2/16/2015
Sonoma Orthopedic Products Inc. Receives 510(K) FDA Clearance For The Minimally-Invasive Fibulock Nail For Ankle Fracture Repair 2/16/2015
Medtronic, Inc. (MDT) Receives Expanded Indications Of The VERTEX Reconstruction System 2/16/2015
FDA Approves Pelvalon's Eclipse System, the First Vaginal Insert for Bowel Control 2/13/2015
Cepheid (CPHD) Scores FDA Approval for Expanded Claims on Tuberculosis Test 2/13/2015
Sequent Medical Inc. Announces Approval To Utilize Latest Generation WEB Devices In U.S. IDE Study 2/13/2015
Titan Spine Receives FDA Clearance to Launch Endoskeleton® TCS Device for Cervical Fusion with Integrated Fixation 2/12/2015
Silk Road Medical's Anti-Stroke Enroute Device Wins FDA Approval 2/10/2015
NanoTherapies Wins Expanded 510(K) Marketing Clearance From the FDA for NanoFUSE DBM 2/10/2015
Agendia BV Receives New FDA Clearance for MammaPrint FFPE Breast Cancer Test 2/10/2015
FDA Clears System To Reduce Stroke Risk During Stent And Angioplasty Procedures 2/9/2015
FDA Clears New Blood-Draw Technology From Velano Vascular Designed To Reduce Needle Exposures For Hospitalized Patients And Healthcare Providers 2/9/2015
Sorin Group Receives Regulatory Approval For New Generation MRI Compatible Pacing System In Japan 2/6/2015
Medtronic, Inc. (MDT)'s Pipeline™ Flex Embolization Device Receives FDA Approval 2/5/2015
FDA Approves Cohera Medical, Inc.'s First-Ever Tissue Adhesive for Use in Surgery 2/5/2015
Lombard Medical Technologies (LMT.L) Wins FDA Approval for Aorfix Plus Endovascular Stent Graft 2/5/2015
20/20 Imaging Announces FDA Approval Of Digital X-Ray System 2/4/2015
FDA Approves 3D-Koning Breast CT 2/4/2015
W. L. Gore & Associates, Inc. Receives Health Canada Approval For GORE® VIABAHN® Endoprosthesis Innovations, Treating Peripheral Vascular Disease 2/4/2015
Orth Align Inc. Receives CE Mark Approval for ORTHALIGN PLUS® the Most Complete Palm-Sized Positioning Device For Use in Total Hip Arthroplasty Surgery 2/3/2015
Amedica Corporation Becomes First To Receive FDA Clearance For Two-Level Cervical Interbody Cage Indications 2/3/2015
SpineGuard Receives FDA Clearance To Market Its Pediguard Products For Minimally Invasive Surgery (MIS) 2/3/2015
Bioceptive's Novel Women's Health Device Receives FDA Clearance 2/2/2015
CytoSorbents, Inc. Announces FDA Approval To Commence Initial U.S. Cardiac Surgery Study 2/2/2015
IRIDEX Corporation (IRIX) Receives FDA Clearance for Cyclo G6™ Laser System for the Treatment of Multiple Stages of Glaucoma 2/2/2015
Medscape, LLC Wins FDA Approval of New 3D Printed Titanium Bone Tether Plate 2/2/2015
Signal Genetics LLC (SGNL) Receives Conditional Approval Of Investigational Device Exemption For MyPRS® 2/2/2015
Medtronic, Inc. (MDT) Expands Access To The Next Generation CoreValve Evolut R System With New Valve Sizes 2/2/2015
InSpire MD Shows Off New Data, CE Mark for CGuard Carotid Stent 1/30/2015
AngioDynamics (ANGO) Receives Expanded "No Chest X-Ray" FDA Clearance For Celerity Tip Location System 1/29/2015
AliveCor Announces FDA Clearance for Two New Automated Detectors For Normal Recordings And Noise Interference 1/29/2015
ZONARE Medical Systems, Inc. Recieves Health Canada Clearance Of Z.One PRO Ultrasound System 1/29/2015
Zeltiq  (ZLTQ) Receives FDA Clearance To Perform Coolsculpting® Procedure At Lower Temperatures For Shorter Treatment Times 1/29/2015
Aerocrine Receives Japanese Health Authority Clearance For NIOX VERO® 1/29/2015
St. Jude Medical (STJ) Snags FDA Approval for FlexAbility Ablation Catheter 1/28/2015
Abiomed (ABMD) Receives FDA HDE Approval for the Impella RP 1/28/2015
Aesculap Implant Systems, Inc.’s Odontoid Fracture Fixation System Receives FDA 510(k) Approval 1/28/2015
Blue Belt Technologies, Inc. Announces CE Mark For STRIDE™ Unicondylar Knee System 1/28/2015
FDA OKs DexCom (DXCM)'s First Medical App System to Monitor Glucose 1/27/2015
InSpire MD Receives CE Mark Approval For Its New CGuard RX And Announces Positive Six Month Follow-Up CARENET Trial Data At LINC 2015 1/27/2015
LeukoDx Receives European CE Mark Approval And ISO Certification For Accellix™ 1/27/2015