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Medical Dev. & Diag. - Approvals
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
FDA Approves DexCom (DXCM) G5 Mobile Continuous Glucose Monitoring System 8/25/2015
Medeon Biodesign Snags FDA Approval for New Lens Cleaning Device 8/25/2015
Veritas Genetics' myBRCA Genetic Test Wins CE Mark 8/25/2015
Boston Scientific (BSX) Wins CE Mark For MRI Compatible Labeling For ICD And CRT-D Systems 8/25/2015
Bacterin's Xtant Medical Wins FDA Approval of OsteoSelect PLUS 8/25/2015
St. Jude Medical (STJ) Wins CE Mark for Prodigy MRI with Select Leads 8/24/2015
FDA Green Lights Boston Scientific (BSX)'s Innova Stent for Peripheral Artery Disease 8/20/2015
Tyber Medical Grabs FDA Nod for TyWedge Evans and Cotton Wedge Systems 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
GlySens Secures FDA Approval to Extend Second Generation Fully-Implanted CGM Sensor Evaluation from 6 to 12 Months 8/17/2015
GE Healthcare First to Win FDA Approval for Low Dose CT Lung Cancer Screening 8/17/2015
Zyga Technology, Inc. Receives 510(k) Clearance for SImmetry Sacroiliac Joint Fusion System Updates 8/13/2015
Cohera Medical, Inc. Receives CE Marking Approval For Sylys Surgical Sealant 8/13/2015
NOWDiagnostics Wins FDA Approval for ADEXUSDx hCG Test 8/13/2015
Uptake Medical Receives CE Mark Approval For InterVapor Targeted Ablation Therapy For Severe Emphysema 8/12/2015
Apollo Endosurgery's Gastric Balloon for Obesity Wins FDA Approval 8/12/2015
Cymedica Orthopedics Receives CE Mark For The CyMedica QB1 Muscle Activation System 8/11/2015
FDA Clears Seven-Day Platelet Storage And Wireless Capability For The Trima Accel System From Terumo BCT 8/10/2015
Health Canada Approves he Glaukos iStent inject 8/10/2015
Stryker Wins FDA Approval for MAKO (MAKO)'s Total Knee Application 8/10/2015
Saudi Food And Drug Authority Approves CytoSorb 8/10/2015
Flowonix Announces FDA Approval Of New Product 8/7/2015
FDA Green Lights First 3D Printed Drug From Aprecia 8/6/2015
FDA Approves 28 Additional Styles Of Allergan (AGN)'s Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants 8/6/2015
Sorin Group S.p.A. (SRN) Obtains Health Canada Approval for Perceval, Its Next Generation Sutureless Valve 8/5/2015
Elekta Receives US 510(k) Clearance For Its Latest Generation Intracranial Radiosurgery System, Leksell Gamma Knife Icon 8/5/2015
Pittsburgh Life Sciences Greenhouse Portfolio Client Medrobotics Receives FDA Market Clearance 8/4/2015
TriVascular, Inc. (TRIV) Wins FDA Approval Of The Ovation Ix Abdominal Stent Graft System 8/4/2015
OraSure Technologies, Inc. (OSUR) Snags FDA Emergency Use Authorization for Ebola Rapid Diagnostic Test 8/3/2015
Fresenius Kabi AG Wins FDA Clearance For 7-Day Platelet Storage Using Fenwal Amicus System 8/3/2015
Ulthera Snags Two Year FDA Clearance for Cellfina System 8/3/2015
FDA Clears Way For Commercial Marketing Of Sentrian Remote Patient Intelligence Solution 7/31/2015
Teleflex Incorporated (TFX) Release: ARROW Endurance Extended Dwell Peripheral Catheter System Receives FDA Market Clearance 7/30/2015
Glaukos Receives Regulatory Approval In Australia For Istent Inject 7/30/2015
Japanese Approval Trial For Stress Urinary Incontinence Using Cytori Therapeutics, Inc. (CYTX) Cell Therapy Announced 7/30/2015
NeuWave Medical Wins FDA Nod for Ablation Confirmation Software 7/30/2015
EMBA Medical Limited Awarded CE Certificate For Hourglass Peripheral Embolization Plug 7/29/2015
Corvida Medical Receives FDA 510 Clearance for Halo Closed System Transfer Device 7/29/2015
inSleep Health's Cloud9 Anti-Snoring System Receives FDA Clearance 7/29/2015
Bay Area's C2 Therapeutics Wins FDA Nod for the Coldplay Cryoballoon Full and Swipe Ablation Systems 7/29/2015
FDA Green Lights ReShape Medical's Weight Loss Stomach Balloon 7/29/2015
Medigus (MDGS.TA) Receives Approval From Israeli Ministry Of Health To Market The MUSE System 7/28/2015
Dynatronics Corporation (DYNT) Awarded CE Mark Approval For Its Solaris Products 7/27/2015
Syneron Medical Ltd. (ELOS) Receives Korean MFDS Regulatory Clearance For PicoWay Picosecond Laser 7/27/2015
Medrobotics Receives FDA Clearance To Market Flex Robotic System 7/23/2015
True Diagnostics, Inc. Receives China CFDA Clearance For JIANJIE TSH Test Kit And BOCHI Reader 7/23/2015
Miramar Labs Announces FDA Clearance For The Permanent Reduction Of Underarm Hair Of All Colors And Subsequent Launch Of Mirasmooth. 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
INOVA Diagnostics Wins FDA Approval for QUANTA Flash Connective Tissue Disease Assays and Beta-2 Glycoprotein1 Domain1 7/20/2015
Meridian Bioscience (VIVO) Snags FDA OK for New Molecular Amplification Test: illumigene HSV 1&2 7/20/2015
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
Magellan Diagnostics Receives FDA Clearance for LeadCare Plus Clinical Lead Analyzer 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
Alere (ALR) Receives FDA CLIA Waiver For Alere i Strep A Rapid Molecular Test 7/16/2015
Remedium Technologies Receives FDA Clearance For Hemogrip Technology To Help Stop Bleeding 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
FDA Clearance For joimax Endolif On-Cage: 3D-Printed Fusion Implant 7/13/2015
Thoratec Corporation (THOR) Receives CE Mark Approval For HeartMate PHP 7/13/2015
RIVANNA Has Received FDA Clearance Of Its Accuro Device 7/13/2015
Renishaw Announces CE Mark And European Launch Of The Neurolocate Frameless Patient Registration System 7/10/2015
Neogen Corporation (NEOG)'s ANSR For Listeria monocytogenes Receives AOAC Approval 7/10/2015
B.Braun Medical Wins FDA Approval for 70% Dextrose Injection, USP 7/9/2015
Lexmark Healthcare Receives FDA 510(k) Class II Clearance For NilRead Enterprise Viewer 7/9/2015
FDA Clears Next-Generation Guide Wire For Cardiovascular Systems' Peripheral Orbital Atherectomy Systems 7/7/2015
DNA Genotek Receives CE-IVD Mark For Its Omnigene•GUT Microbiome Collection Kit 7/7/2015
Cynosure (CYNO) Grabs Expanded FDA 510(k) Approval for SculpSure 7/7/2015
Mauna Kea Technologies Receives Regulatory Approval For The AQ-Flex 19 Miniprobe In Japan 7/6/2015
Flower Orthopedics Cleared To Enter The European Union 7/6/2015
Kubtec Announces FDA Approval of DIGIVIEW 395 High Resolution Wireless Flat Panel Detector 7/6/2015
FDA Green Lights Theranos' Blood Test for Herpes 7/6/2015
Proteus Digital Health Release: First Medical Device Cleared By FDA With Adherence Claim 7/2/2015
Cochlear Limited Snags FDA Approval of the Cochlear Nucleus Profile Implant With Slim Straight Electrode (CI522) 7/2/2015
Hansen Medical (HNSN) Announces FDA Clearance of the Magellan 10Fr Robotic Catheter 7/2/2015
GlySure Secures CE Mark And Launches World’s First Continuous Intravascular Glucose Monitoring System 7/1/2015
Bayer (BAY) Release: FDA Approves Alternate Confirmation Test For Essure Permanent Birth Control 7/1/2015
MX Orthopedics Grabs FDA Nod for The dynaMX Compression Staple Featuring Malleable Nitinol Technology 7/1/2015
SpineGuard Obtains Regulatory Clearance To Sell Pediguard In The World’s Second-Largest Spine Market: China 6/30/2015
BioLight Obtains EU CE Mark for CellDetect Non-Invasive Test For Detecting Recurrence Of Bladder Cancer 6/30/2015
Velano Vascular Receives CE Mark for Novel Blood Draw Technology Designed to Reduce Needle Exposures for Hospitalized Patients and Healthcare Providers 6/29/2015
Caldera Medical Announces FDA Clearance For New Generation Of Vertessa Lite Polypropylene Mesh For Sacrocolpopexy 6/29/2015
Biomerica (BMRA) Announces Its First Brazilian Anvisa Approvals And A New Distribution Channel In Brazil 6/29/2015
Exactech (EXAC) Grabs FDA Approval for Its Optetrak Logic Constrained Condylar Prosthesis 6/29/2015
Caldera Medical Announces FDA Clearance for New Generation of Vertessa Lite Polypropylene Mesh for Sacrocolpopexy 6/26/2015
Cochlear Limited Release: FDA Approves Technology Upgrade For Recipients Of First Commercially Available Cochlear Implant 6/25/2015
Spectranetics (SPNC) Receives FDA 510(k) Clearance for Larger Diameter AngioSculpt Scoring Balloon Enabling Entry Into New Markets 6/25/2015
Exactech, Inc. (EXAC) Receives FDA 510(K) Clearance For Its Optetrak Logic Constrained Condylar Prosthesis 6/25/2015
Ortho Clinical Diagnostics Announces FDA Approval of VITROS Chemistry Products HbA1c Reagent Kit for Diagnosis of Diabetes 6/24/2015
Medtronic (MDT)'s First Recapturable Heart Valve Receives FDA Approval 6/23/2015
Torax Medical Announces FDA Approval Of A New LINX Device Compatible With 1.5 Tesla Magnetic Resonance Imaging (MRI) Systems 6/23/2015
Medtronic (MDT) Bags CardioInsight Tech in Net $93 Million+ Performance Bonuses Deal 6/22/2015
Masimo Corporation (MASI) Receives CE Mark for MightySat Rx Pulse Oximeter 6/22/2015
Sonomed, Inc. Receives FDA Approval For Device With Wearable Compliance Micro-Chip 6/22/2015
Edwards Lifesciences (EW) Soars After FDA Approves Heart Valve 6/18/2015
Ortho-Clinical Diagnostics Receives FDA 510k Clearance For VITROS® Chemistry Products Hba1c Reagent Kit, An Enhanced Diabetes Testing Assay 6/18/2015
ALung Technologies Receives CE Mark For New Hemolung XG4 Cartridge And Catheter Kits 6/18/2015
BTL Vanquish By BTL Industries Receives FDA Clearance For Non-Surgical Circumferential Reduction Of The Abdomen 6/17/2015
Centinel Spine Wins Allogeneic Bone Graft Indication From the FDA for Its Anterior Lumbar Product Family 6/17/2015
FDA Green Lights St. Jude Medical (STJ)'s Brain Implant for Parkinson's Disease 6/16/2015
Breathe Tech Announces FDA Clearance For Life2000 Ventilation System 6/15/2015
TriVascular, Inc. (TRIV) Snags FDA Approval of Ovation iX Iliac Stent Graft 6/15/2015
FH Ortho Receives FDA 510(K) Clearance For Its Calcanail Orthopedic Arthrodesis Nail 6/15/2015
Delta International Service & Logistics Receives FDA 510(K) Clearance For Scrambler Therapy Technology MC-5A 6/15/2015
Ventana Medical Systems (VMSI) Wins FDA Nod for the First Fully Automated IHC Companion Diagnostic to ID Lung Cancer Patients Eligible for XALKORI 6/15/2015
Merck KGaA (MKGAF.PK), Darmstadt, Germany: Innovative Fertility Technologies Gavi And Geri Of Partner Genea Biomedx Receive CE Mark 6/15/2015
Sanovas Recieves FDA Clearance for PulmoVia 6/12/2015
Beckman Coulter, Inc. (BEC) Gets CE Mark for HCV, HIV-1 MDx Tests 6/12/2015
Ariosa Diagnostics Wins CE Mark For Its FORTE Software To Support Harmony Prenatal Test 6/11/2015
Cerebral Assessment Systems Receives FDA de novo Approval For Cognivue Cognitive Assessment Aid 6/11/2015
Sebia Brings To Market New Capillarys 3 Tera Automated System With CE Mark Hba1c And Serum Protein Testing, And Immunotyping 6/10/2015
Bio-Rad (BIO) Snags FDA Approval for Diagnosing Diabetes With Its VARIANT II TURBO HbA1c Kit - 2.0 6/10/2015
Elekta CE Marks Leksell Gamma Knife Icon, Designed To Treat A More Expansive Range Of Cranial Targets 6/10/2015
Linkage Biosciences Announces CE Mark For World's First Real-Time PCR HLA Test 6/9/2015
Stimwave Receives FDA Approval For High Frequency IDE Utilizing The World’s First And Only Eight-Electrode, Multi-Programmable Wireless Miniature Injectable Stimulator 6/9/2015
Mauna Kea Technologies Announces CE Mark For Use Of Cellvizio During Interventional Radiology Procedures 6/9/2015
Elekta CE Marks Leksell Gamma Knife Icon, Designed To Treat A More Expansive Range Of Cranial Targets 6/9/2015
Oculus Innovative Sciences, Inc. (OCLS) Receives FDA Clearance For Novel Atopic Dermatitis Dermatology Product 6/9/2015
A Significant Achievement For Allium Medical: Gardia's WIRION Embolic Protection Device Received FDA Clearance For The Carotid Indication 6/9/2015
Medtronic (MDT) Receives FDA Clearance Of MiniMed Connect For More Convenient Access To Personal Diabetes Data 6/5/2015
Actavis (ACT) Snags FDA Approval Of NATRELLE INSPIRA Round Gel-Filled Textured Breast Implants 6/5/2015
FDA Green Lights NovaBay (NBY)’s New High-Tech Device intelli-Case 6/4/2015
Roche (RHHBY) Wins FDA Approval for the Cobas HSV 1 And 2 Test 6/4/2015
St. Jude Medical (STJ) Grabs CE Mark Approval of Industry's First Neuromodulation Trial System to Employ Apple and Bluetooth Wireless Technology 6/4/2015
Monarch Medical Receives FDA 510(K) Clearance for Endotool SubQ 6/3/2015
Chembio Diagnostics, Inc. (CEMI.OB)'s DPP HIV 1/2 Assay Receives CE Mark Approval For Rapid Point-Of-Care Detection Of HIV 6/3/2015
Carestream Health’s Ultrasound Systems Wins FDA 510(k) Clearance; Now Available for Order in U.S. 6/2/2015
Cyberonics (CYBX) Announces FDA Approval Of The AspireSR Generator For VNS Therapy 6/2/2015
Medical Informatics Corp (MIC) Sickbay Clinical Platform Receives FDA 510(K) Clearance 6/2/2015
Piramal Imaging SA And Ci-Co Healthcare Announce Commercial Approval Of Neuraceq In Korea 6/2/2015
Rivanna Medical Has Received FDA Clearance For Accuro 6/1/2015
Mobidiag Announces CE Marking Of Novel Helicobacter Pylori And Clarithromycin Resistance Test 5/29/2015
SuperSonic Imagine Announces Regulatory Clearance Of The Next-Generation Aixplorer Ultrasound System In Japan 5/29/2015
tosense Wins FDA Approval for Heart Monitoring Necklace 5/28/2015
SurgiQuest's AirSeal® System Snags FDA 510(k) Clearance for Transanal Endoscopic Surgery 5/28/2015
Penumbra, Inc. ACE64 Cleared For Marketing By FDA For Acute Ischemic Stroke Patients 5/27/2015
RegenScientific Announces FDA-Clearance Of Its Renu Gel Injectable Implant 5/27/2015
EOS Imaging Grabs CE Mark for kneeEOS, the first 3D Stereo-Radiographic Planning Software for Total Knee Arthroplasty 5/27/2015
InvisionHeart Grabs FDA Approval for its InvisionECG Technology 5/27/2015
Seegene Receives CE Mark For First Comprehensive Real-time PCR Gastrointestinal Infection Panels 5/26/2015
Verax Biomedical, Incorporated Gains FDA Clearance For Expanded Platelet Safety Measure Testing Indications 5/26/2015
Roche (RHHBY) Snags FDA Approval for the Cobas Cdiff Test 5/26/2015
VertiFlex Announces FDA PMA Approval For The Superion Interspinous Spacer 5/26/2015
Thoratec Corporation (THOR) Receives Conditional FDA Approval For The Shield II U.S. Clinical Trial For HeartMate PHP 5/26/2015
Emmes Announces FDA Clearance of New Medical Device 5/20/2015
B.Braun Medical Wins FDA Nod to Offer Broad Spectrum Intravenous Antibiotic-Meropenem, in Its Innovative DUPLEX Container 5/20/2015
Implanet: CE Mark And FDA Clearance In The United States For New JAZZ Diameters 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
Cynosure (CYNO) Nabs FDA Approval for SculpSure, the World's First Hyperthermic Laser Treatment for Non-Invasive Fat Reduction 5/19/2015
BrainScope Company, Inc.’s Ahead 200 Device Cleared By FDA For Adjunctive Assessment Of Traumatic Brain Injury 5/19/2015
Abbott (ABT) Announces CE Mark For New Advancement Of Absorb Stent System For People With Heart Disease 5/19/2015
Nitiloop Wins FDA Approval for its NovaCross Microcatheter 5/18/2015
Mauna Kea Technologies Announces CE Mark For Use Of Cellvizio In Minimally Invasive Surgery 5/18/2015
Arterial Remodeling Technologies (ART) Announces CE Mark Clearance For Its Pure Bioresorbable Scaffold 5/18/2015
St. Jude Medical (STJ) Expands Portfolio Of MRI-Compatible Devices To High Voltage In Europe 5/13/2015
COPAN Is Proud To Announce FDA Clearance For FecalSwab To Standardize And Simplify Enteric Culture And Molecular Diagnostics 5/13/2015
Ablative Solutions Announces CE Mark Of The Peregrine System Infusion Catheter 5/13/2015
Aethlon Medical (AEMD) Announces Health Canada Approval Of Ebola Treatment Protocol 5/13/2015
Becton, Dickinson and Company (BDX) Wins FDA Approval for a Novel Infusion Set With BD Flowsmart Technology 5/13/2015
Medtronic (MDT) Wins FDA Nod and CE Mark for Arctic Front Advance ST Cryoballoon 5/12/2015
Aethlon Medical (AEMD) Announces Institutional Review Board Approval of Multi-Indication Cancer Study 5/12/2015
Genesys Spine Earns ISO Certifications, CE Mark 5/12/2015
Roche (RHHBY) Wins FDA Approval for cobas KRAS Mutation Test 5/11/2015
Nevro Snaps Up FDA Approval for Senza Spinal Cord Stimulation System 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
Yolo Medical Wins FDA Approval for Body Contouring Laser 5/4/2015
FDA Clears Invictus Medical’s GELShield for Market Launch 5/4/2015
Sonendo Receives 510(K) FDA Clearance For Its Multisonic Ultracleaning System 5/4/2015
Medtronic (MDT) Snags FDA Approval for ZEVO Anterior Cervical Plate System 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 Neurosurgery Receives Expanded Indications For The StealthStation Electromagnetic Surgical Navigation Technology 5/4/2015
St. Jude Medical (STJ) Wins FDA Approval for World’s Smallest Upgradeable MR-Conditional Spinal Cord Stimulation System 5/1/2015
Stentys’ Next-Generation Of Self-Apposing Stent System Receives CE Marking Ahead Of Plan 4/29/2015
BoneSupport Wins CE-Mark of CERAMENT|V 4/29/2015
Ortho-Clinical Diagnostics Receives Health Canada Approval For ORTHO VISION Analyzer 4/28/2015
Strauss Surgical Announces Health Canada Regulatory Approval Of The Strauss Optiks HD Endoscopes 4/28/2015
BioSure Launches World's First HIV Self-Testing Kit 4/27/2015
Avita Medical Granted CE Mark For Expanded ReCell 4/27/2015
Vital Art and Science, LLC (VAS) Release: First FDA Cleared Ophthalmic App For Monitoring AMD And DR 4/27/2015
FH Ortho Receives FDA 510(K) Clearance For Its Arrow Reverse Shoulder Long Keel & Short Keel Glenoid Base 4/27/2015
Oxford Immunotec Limited (OXFD) Announces CE Mark Approval for T-SPOT.CMV Test 4/27/2015
Avita Medical Snags CE Mark for Expanded ReCell 4/27/2015
InSpire MD Announces MGuard Prime Approval In Brazil 4/27/2015
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
Nipro Diagnostics Grabs FDA Approval for TRUE METRIX AIR 4/24/2015
Elekta CE Marks For Monaco V5.10 Treatment Planning System 4/24/2015
Coloplast (COLOB.CO)'s Penile Prosthesis Approved for Ectopic Placement 4/23/2015
FDA Green Lights Siemens (SI)' Breast Tomo Device 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
Syneron Candela's PicoWay Picosecond Laser Receives U.S. FDA Clearance For Treatment Of Pigmented Lesions 4/20/2015
FDA Approves AcuFocus' First-of-Its-Kind Corneal Implant 4/20/2015
Cardiovascular Systems Snags FDA Approval for New Peripheral Diamondback Device 4/20/2015



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