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Medical Dev. & Diag. - Approvals
BIOTRONIK SE & Co.KG Release: FDA Approves Only ICD With Ultra-High Energy On The First Shock 4/17/2015
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
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
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
Perseon Announces FDA Clearance for Specific Indication of Non-Resectable Liver Tumor Ablation 4/14/2015
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
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
Pelvalon Announces Clinical Data from Original Proof-of-Concept Study for Eclipse, the First Vaginal Device for Bowel Control 4/1/2015
Baxter International (BAX) Completes CE Mark Approval for HOMECHOICE CLARIA Automated Peritoneal Dialysis System with SHARESOURCE 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
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
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
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
Cynosure, Inc. (CYNO) Announces FDA Clearance of New 532 nm Laser Delivery System for PicoSure 2/24/2015
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
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
Dallen Medical Wins FDA Approval for New Tensyn Plug 2/17/2015
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
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
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
Abiomed (ABMD) Receives FDA HDE Approval for the Impella RP 1/28/2015
FDA OKs DexCom (DXCM)'s First Medical App System to Monitor Glucose 1/27/2015
Agilent Technologies Inc. (A) Microarray Scanner Approved For In Vitro Diagnostics In China 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
Roche (RHHBY) Wins FDA Approval for Next-Gen Cobas MRSA/SA Test 1/26/2015
FDA Approves Pulmozyme with eRapid Nebulizer; CF Patients See 2 - 3 Minute Treatment Times 1/26/2015
EOS Imaging Receives FDA Clearance For Micro Dose 1/26/2015
Bay Area's Nevro Corp Nabs FDA Approval for Senza® Spinal Cord Stimulation System 1/23/2015
FDA Green Lights Medtronic, Inc. (MDT) System To Treat Serious Stomach Disorder 1/23/2015
FDA Green Lights MED-EL's SYNCHRONY Cochlear Implant 1/23/2015
BioStructures, LLC Receives FDA Clearance for Silhouette™ Mineralized Collagen Scaffold 1/22/2015
AliveCor Receives CE Mark on Atrial Fibrillation Algorithm 1/22/2015
Erba Diagnostics Attains CE Mark for HB Vario A1c Detection System and Reagents for Management of Diabetes 1/21/2015
K2M Receives FDA 510(K) Clearance For The Next Generation Of Its Innovative Complex Spine MESA® Technology 1/21/2015
Applied Spectral Imaging (ASI) Grabs FDA Approval for GenASIs™ HiPath Image Capture and Analysis Platform 1/21/2015
Hospira, Inc. Receives FDA Clearance For Plum 360™ Infusion System 1/20/2015
Cantel Medical (CMN) Subsidiary Mar Cor Purification Given 510(K) Clearance for MINNCARE® HD Disinfectant for Use in Water System Disinfection in Kidney Dialysis Applications 1/16/2015
Zyno Medical Announces CE Mark Approval For the Z--00 Infusion Pump System 1/16/2015
The Obesity Society: FDA Approves First Medical Device For Obesity Treatment Targeting Brain-To-Stomach Signaling 1/16/2015
FDA Approves EnteroMedics (ETRM)' First-of-Its-Kind Obesity Device 1/15/2015
Signostics Gets FDA 510k Clearance For Handheld Bladder Scanner 1/15/2015
ALung Technologies Receives Marketing Clearance For Hemolung RAS In Australia 1/15/2015
CeraPedics, Inc. Receives CE Mark and TGA Listing for New i-FACTOR™ Flex FR Biologic Bone Graft 1/14/2015
DIAXONHIT Announces The CE Marking Of The BJI Inoplex® Test And Its Commercial Launch 1/14/2015
ALung Technologies Receives Marketing Clearance For Hemolung RAS In Australia 1/14/2015
Intact Medical Corporation Wins Expanded Approval for the Intact® System 1/13/2015
Valorem Surgical Snags FDA Approval and First Clinical Use of MaxiMIS™ Spinal Fixation System 1/13/2015
Tandem Diabetes Care Announces FDA Clearance Of The t:flex™ Insulin Pump 1/12/2015
Health Canada Approves Second Sight’s Argus II Retinal Prosthesis System For Treatment Of Outer Retinal Degeneration 1/12/2015
PorOsteon Wins FDA Approval for Phusion Metal™ Cervical Cage 1/9/2015
FDA Approves Roche (RHHBY)'s Blood Test to Identify Three Viruses 1/9/2015
HGI Industries Snags FDA Approval of The Odorox MDU/Rx Device for Use in Medical Facilities 1/9/2015
BiO2 Medical, Inc. Receives IDE Approval To Initiate Pivotal Investigation Of The Angel® Catheter 1/9/2015
EDAP TMS S.A. (EDAP)'s Focal One HIFU Device Approved By Health Canada 1/9/2015
Chipscreen Biosciences Announces CFDA Approval Of Chidamide (Epidaza) For PTCLs In China 1/9/2015
Spiracur Receives FDA Clearance And CE Mark Approval Of Snap Plus Wound Care Cartridge 1/9/2015
Covidien plc (COV)’s Stellarex™ Drug-Coated Angioplasty Balloon Receives CE Mark To Treat Peripheral Arterial Disease Patients 1/9/2015
Myriad Genetics, Inc. (MYGN) Wins CE Mark for Tumor BRACAnalysis CDx™ 1/8/2015
HGI Industries Announces FDA Approval Of The Odorox MDU/Rx Device For Use In Medical Facilities 1/8/2015
Straub Medical AG Obtains Approval For Rotarex®S And Aspirex®S Endovascular Catheters In China 1/8/2015
Royal Philips Electronics N.V. (PHG) Wins FDA Approval for Latest Avalon CL Fetal Monitoring Solution 1/7/2015
FDA Approves Alere Inc. (ALR)'s 15 Minute Flu Tests for Doctors' Offices 1/7/2015
Viztek Announces FDA Approval of Exa PACS 1/7/2015
The Becton, Dickinson and Company (BDX) Intelliport® Medication Management System Receives Clearance From The FDA 1/7/2015
EarlySense's Latest Contact-Free Monitoring Solution Approved For Use In Canada 1/7/2015
Shockwave Medical Announces CE Mark Approval Of Its Lithoplasty System For The Treatment Of Peripheral Artery Disease 1/7/2015
VasoPrep Surgical Announces De Novo Product Clearance by FDA 1/6/2015
dBMEDx Announces FDA Clearance of the BBS Revolution™ Bladder Scanner 1/6/2015
AUM Cardiovascular’s Acoustic Heart-Disease Detector Lands European Approval 1/6/2015
Quanta Wins CE Mark for Advanced Haemodialysis System SC+ 1/6/2015
FDA Green Lights Medtronic, Inc. (MDT)'s In.Pact Admiral Balloon 1/5/2015
Stereotaxis, Inc. (STXS) Wins FDA Approval of Vdrive® With V-CAS™ System 1/5/2015
FDA Approves Bayer HealthCare AG (BAY)'s Gadavist® (gadobutrol) Injection As The First Magnetic Resonance Contrast Agent For Pediatric Patients Less Than 2 Years Of Age 1/5/2015
Dune Medical Devices Ltd. Announces FDA Approval of Updated Version of MarginProbe With Feature Enhancements, Further Improving User-Friendly Experience for Surgeons 1/5/2015
FDA Green Lights Roche (RHHBY)s Ebola Test for Emergency Use 12/29/2014
Cepheid (CPHD) And FIND Announce European Approval Of Xpert HIV-1 Viral Load 12/29/2014
NxStage Medical, Inc. (NXTM) Wins FDA Approval for Home Nocturnal Hemodialysis 12/23/2014
Myriad Genetics, Inc. (MYGN) Snags FDA Approval of BRACAnalysis CDx as Companion Diagnostic for Lynparza 12/22/2014
Myriad Genetics, Inc. (MYGN) Receives FDA Approval Of BRACAnalysis CDx™ As Companion Diagnostic For Lynparza™ (olaparib) In Ovarian Cancer Patients 12/19/2014
Vascular Solutions (VASC) Snags FDA Approval Of Zigiwire™ Access Guidewire System 12/19/2014
Bio2 Technologies, Inc. Grabs FDA Nod For CLM Bioactive Scaffold 12/19/2014
Roxwood Medical Announces FDA 510(K) Clearance And US Commercial Launch Of Its CenterCross Catheter 12/19/2014
Quidel Corporation (QDEL) Nabs FDA ApprovalFor Its Sofia® Strep A+ Fluorescent Immunoassay (FIA) 12/18/2014
Vital Images, Inc. (VTAL)' Endovascular Stent Planning Application With Fenestrated Stent Planning Receives FDA Clearance 12/17/2014
Invibio Release: First European Approval For Implant Made Of PEEK-OPTIMA HA Enhanced 12/17/2014
Allaccem, Inc. Receives Formulary Approval For SANOS® From The Veterinary Medical Standardization Board Of The US Army Public Health Command 12/17/2014
Sorin Group S.p.A. (SRN) Wins FDA Approval For First U.S. Implant Of Memo 3D Rechord™ Annuloplasty Ring 12/17/2014
FDA Green Lights Cerus Corporation (CERS) System To Cut Blood Transfusion Infections 12/17/2014