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Medical Dev. & Diag. - Approvals
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
ClarVista HARMONI Receives CE Mark For Europe 9/28/2015
Bayer HealthCare (BAY) Receives FDA Approval for BETACONNECT - First and Only Electronic Autoinjector in Relapsing-Remitting Multiple Sclerosis (RRMS) Treatment 9/28/2015
Becton, Dickinson and Company (BDX) MAX Enteric Parasite Panel Receives FDA Clearance For Detection Of Common And Pathogenic Intestinal Parasites 9/25/2015
Zeltiq  (ZLTQ) Receives FDA Clearance To Treat Submental Fat With Coolsculpting Procedure 9/25/2015
Bolton Medical Receives CE Mark For TREO Abdominal Stent-Graft System 9/24/2015
Advanced Catheter Therapies Receives Second FDA 510(k) Clearance On Occlusion Perfusion Catheter 9/23/2015
B. Braun Medical Receives FDA Clearance for Infusomat Space Pump 9/23/2015
Implanet: New JAZZ Band FDA Clearance Expands Posterior Fixation System Selection 9/23/2015
VolitionRX Wins First CE Mark for NuQ Blood Assay for Colorectal Cancer Detection 9/22/2015
Ceterix Orthopaedics Wins FDA Approval for Next-Gen Meniscus Repair Device 9/22/2015
St. Jude Medical (STJ) Grabs CE Mark for the New Infinity Deep Brain Stimulation System and Directional DBS Lead 9/22/2015
Valtech Cardio To Host Cardioband Symposium, Following Receipt Of CE Marking For Cardioband Mitral Reconstruction System 9/21/2015
Fast and Reliable Results in Cancer Diagnostics: Biotech Startup Oncgnostics Receives CE Mark for Cervical Cancer Test 9/18/2015
DeGen Medical Receives Clearance of Hyper-C Anterior Cervical Plate System 9/18/2015
St. Jude Medical (STJ) Gains CE Mark for 27mm & 29mm Portico TAVR Valves to Complete a Full Portfolio of Portico Sizing Options for Physicians Treating Patients With Aortic Stenosis 9/18/2015
Precision Spine Announces FDA Approval of the Reform Modular and HA Coated Pedicle Screw Systems 9/18/2015
Picofemto Gains FDA Clearance Of Cliniscan(Sm) Platform And Eeg Analysis 9/17/2015
Cynosure (CYNO) Receives Regulatory Clearance In China To Market PicoSure Picosecond Laser For Tattoo Removal 9/17/2015
Cook Medical Receives FDA Approval for the Zenith Alpha Thoracic Endovascular Graft 9/17/2015
Valtech Cardio Wins CE Mark for Cardioband Mitral Repair Device 9/14/2015
Boston Scientific (BSX) Announces CE Mark For The Vercise Primary Cell Deep Brain Stimulation System 9/10/2015
Cynosure (CYNO) Receives CE Mark Approval For SculpSure 9/10/2015
Tandem Diabetes Care Announces FDA Approval Of t:slim G4 Insulin Pump With CGM Integration 9/9/2015
Royal Philips Electronics N.V. (PHG) Receives FDA 510(k) Clearance For Spectral Diagnostic Suite 9/9/2015
Xtant Medical Announces FDA Clearance of the Aranax Cervical Plate 9/9/2015
Nanosphere Grabs FDA Approval for First-of-Its-Kind Flexible Respiratory Pathogens Test 9/8/2015
QT Vascular Announces CE Mark Clearance Of Chocolate Touch By LRQA 0088 9/8/2015
Surgical Theater Receives CE Mark Approval For Its 3D Virtual Reality, Surgical Guidance And Navigation Platforms 9/8/2015
Thermo Fisher Scientific (TMO) Receives IVDD CE Mark for its Thermo Scientific Prelude MD HPLC, Endura MD Mass Spectrometer and ClinQuan MD Software 9/8/2015
Teleflex Incorporated (TFX) Snags FDA Nod for the ARROW® Triple Lumen Pressure Injectable Acute Hemodialysis Catheter 9/3/2015
Salutaris Medical Devices Announces 510(k) Clearance 9/3/2015
NxThera Receives 510(k) Clearance For Rezum System To Improve Lives Of Men Suffering From Symptoms Associated With Benign Prostate Hyperplasia (BPH) 9/3/2015
Focus Diagnostics, Inc. Receives FDA Clearance To Add Genital Swab Claim To Moderate Complexity Simplexa HSV 1 & 2 Direct Molecular Test 9/3/2015
Wright Medical Group (WMGI) Wins FDA Approval for AUGMENT Bone Graft 9/2/2015
Eko Devices Release: FDA Clears Next Generation Stethoscope 9/2/2015
Surefire Wins FDA Approval for Precision Direct-to-Tumor Embolization Device 9/1/2015
Y-STRUT By Hyprevention : CE Mark Obtained 9/1/2015
ZEISS Sets The Pace In OCT Innovation With First FDA 510(K) Clearance Of OCT Angiography Technology 9/1/2015
Integrity Applications Receives CE Mark Approval For Multiple Improvements To GlucoTrack Model DF-F 8/31/2015
MagVenture's Major Depressive Disorder Therapy System Wins FDA Approval 8/28/2015
Analytik Jena Introduces The World’s First Hepatitis D Virus Test With CE-IVD Certification Applying WHO Standard To The Market 8/27/2015
BIOTRONIK Presents Its CRT-Ds Approved For Full-Body MRI Scanning At ESC Congress 2015 8/26/2015
Bacterin's Xtant Medical Wins FDA Approval of OsteoSelect PLUS 8/25/2015
Boston Scientific (BSX) Wins CE Mark For MRI Compatible Labeling For ICD And CRT-D Systems 8/25/2015
Veritas Genetics' myBRCA Genetic Test Wins CE Mark 8/25/2015
Medeon Biodesign Snags FDA Approval for New Lens Cleaning Device 8/25/2015
FDA Approves DexCom (DXCM) G5 Mobile Continuous Glucose Monitoring System 8/25/2015
St. Jude Medical (STJ) Wins CE Mark for Prodigy MRI with Select Leads 8/24/2015
Tyber Medical Grabs FDA Nod for TyWedge Evans and Cotton Wedge Systems 8/20/2015
FDA Green Lights Boston Scientific (BSX)'s Innova Stent for Peripheral Artery Disease 8/20/2015
Ortho Clinical Diagnostics Receives 510(k) Clearance For ORTHO VISION Analyzer, Making It Commercially Available In The United States 8/19/2015
Aurora Spine Wins CE Mark Approval for Sterile-Packed TiNano Coated Interbody Systems 8/18/2015
GE Healthcare First to Win FDA Approval for Low Dose CT Lung Cancer Screening 8/17/2015
GlySens Secures FDA Approval to Extend Second Generation Fully-Implanted CGM Sensor Evaluation from 6 to 12 Months 8/17/2015
NOWDiagnostics Wins FDA Approval for ADEXUSDx hCG Test 8/13/2015
Cohera Medical, Inc. Receives CE Marking Approval For Sylys Surgical Sealant 8/13/2015
Zyga Technology, Inc. Receives 510(k) Clearance for SImmetry Sacroiliac Joint Fusion System Updates 8/13/2015
Apollo Endosurgery's Gastric Balloon for Obesity Wins FDA Approval 8/12/2015
Uptake Medical Receives CE Mark Approval For InterVapor Targeted Ablation Therapy For Severe Emphysema 8/12/2015
Cymedica Orthopedics Receives CE Mark For The CyMedica QB1 Muscle Activation System 8/11/2015
Saudi Food And Drug Authority Approves CytoSorb 8/10/2015
Stryker Wins FDA Approval for MAKO (MAKO)'s Total Knee Application 8/10/2015
Health Canada Approves he Glaukos iStent inject 8/10/2015
FDA Clears Seven-Day Platelet Storage And Wireless Capability For The Trima Accel System From Terumo BCT 8/10/2015
Flowonix Announces FDA Approval Of New Product 8/7/2015
FDA Approves 28 Additional Styles Of Allergan (AGN)'s Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants 8/6/2015
FDA Green Lights First 3D Printed Drug From Aprecia 8/6/2015
Elekta Receives US 510(k) Clearance For Its Latest Generation Intracranial Radiosurgery System, Leksell Gamma Knife Icon 8/5/2015
Sorin Group S.p.A. (SRN) Obtains Health Canada Approval for Perceval, Its Next Generation Sutureless Valve 8/5/2015
TriVascular, Inc. (TRIV) Wins FDA Approval Of The Ovation Ix Abdominal Stent Graft System 8/4/2015
Pittsburgh Life Sciences Greenhouse Portfolio Client Medrobotics Receives FDA Market Clearance 8/4/2015
Ulthera Snags Two Year FDA Clearance for Cellfina System 8/3/2015
Fresenius Kabi AG Wins FDA Clearance For 7-Day Platelet Storage Using Fenwal Amicus System 8/3/2015
OraSure Technologies, Inc. (OSUR) Snags FDA Emergency Use Authorization for Ebola Rapid Diagnostic Test 8/3/2015
FDA Clears Way For Commercial Marketing Of Sentrian Remote Patient Intelligence Solution 7/31/2015
NeuWave Medical Wins FDA Nod for Ablation Confirmation Software 7/30/2015
Japanese Approval Trial For Stress Urinary Incontinence Using Cytori Therapeutics, Inc. (CYTX) Cell Therapy Announced 7/30/2015
Glaukos Receives Regulatory Approval In Australia For Istent Inject 7/30/2015
Teleflex Incorporated (TFX) Release: ARROW Endurance Extended Dwell Peripheral Catheter System Receives FDA Market Clearance 7/30/2015
FDA Green Lights ReShape Medical's Weight Loss Stomach Balloon 7/29/2015
Bay Area's C2 Therapeutics Wins FDA Nod for the Coldplay Cryoballoon Full and Swipe Ablation Systems 7/29/2015
inSleep Health's Cloud9 Anti-Snoring System Receives FDA Clearance 7/29/2015
Corvida Medical Receives FDA 510 Clearance for Halo Closed System Transfer Device 7/29/2015
EMBA Medical Limited Awarded CE Certificate For Hourglass Peripheral Embolization Plug 7/29/2015
Medigus (MDGS.TA) Receives Approval From Israeli Ministry Of Health To Market The MUSE System 7/28/2015
Syneron Medical Ltd. (ELOS) Receives Korean MFDS Regulatory Clearance For PicoWay Picosecond Laser 7/27/2015
Dynatronics Corporation (DYNT) Awarded CE Mark Approval For Its Solaris Products 7/27/2015
Miramar Labs Announces FDA Clearance For The Permanent Reduction Of Underarm Hair Of All Colors And Subsequent Launch Of Mirasmooth. 7/23/2015
True Diagnostics, Inc. Receives China CFDA Clearance For JIANJIE TSH Test Kit And BOCHI Reader 7/23/2015
Medrobotics Receives FDA Clearance To Market Flex Robotic System 7/23/2015
FDA Approves Two New Propeller Health Devices That Track Respiratory Meds 7/22/2015
Abbott (ABT) Grabs FDA Approval for LASIK Vision Device 7/21/2015
St. Jude Medical (STJ) Snags FDA Nod for Industry's Only MR-Conditional 5-Column Paddle Lead for the Management of Chronic Pain 7/20/2015
Meridian Bioscience (VIVO) Snags FDA OK for New Molecular Amplification Test: illumigene HSV 1&2 7/20/2015
INOVA Diagnostics Wins FDA Approval for QUANTA Flash Connective Tissue Disease Assays and Beta-2 Glycoprotein1 Domain1 7/20/2015
Remedium Technologies Receives FDA Clearance For Hemogrip Technology To Help Stop Bleeding 7/16/2015
Alere (ALR) Receives FDA CLIA Waiver For Alere i Strep A Rapid Molecular Test 7/16/2015
St. Jude Medical (STJ) Receives FDA Approval For The Industry's First Spinal Cord Stimulation Trial System To Incorporate Bluetooth® Wireless Technology And Apple Digital Devices 7/16/2015
Magellan Diagnostics Receives FDA Clearance for LeadCare Plus Clinical Lead Analyzer 7/16/2015
Summit Medical Nears Completion Of 510(K) Goals With FDA Clearance For Additional Sterilization Cycles 7/15/2015
QIAGEN N.V. (QGEN) Companion Diagnostic Wins FDA Approval For Use With IRESSA 7/14/2015
RIVANNA Has Received FDA Clearance Of Its Accuro Device 7/13/2015
Thoratec Corporation (THOR) Receives CE Mark Approval For HeartMate PHP 7/13/2015
FDA Clearance For joimax Endolif On-Cage: 3D-Printed Fusion Implant 7/13/2015
Neogen Corporation (NEOG)'s ANSR For Listeria monocytogenes Receives AOAC Approval 7/10/2015
Renishaw Announces CE Mark And European Launch Of The Neurolocate Frameless Patient Registration System 7/10/2015
Lexmark Healthcare Receives FDA 510(k) Class II Clearance For NilRead Enterprise Viewer 7/9/2015
B.Braun Medical Wins FDA Approval for 70% Dextrose Injection, USP 7/9/2015