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Medical Dev. & Diag. - Approvals
Nanowear Wins FDA OK for its Transformative Remote Diagnostic Monitoring Device 12/2/2016
Helsinn Integrative Care Wins FDA Nod for Medical Device Xonrid Gel 12/1/2016
FDA Clears Rodo Medical's Abutment System 11/30/2016
Abbott (ABT) Bags CE Mark for i-STAT Alinity, a Pioneering, Handheld Blood Testing Platform 11/30/2016
biosurfit Receives CE Mark For Its Spinit HbA1c Point-Of-Care Blood Test To Assist Doctors Diagnose And Monitor Diabetes 11/30/2016
BrightWater Medical Release: ConvertX Nephroureteral Stent System Receives FDA Clearance 11/30/2016
Medtronic (MDT) First To Receive European Approval For Less-Invasive HVAD 11/29/2016
Cynosure (CYNO) Receives CFDA Clearance To Market The Icon Aesthetic System In China 11/29/2016
NeuroMetrix (NURO) Receives CE Mark Certification For Quell Wearable Pain Relief Device 11/29/2016
Sound Options Tinnitus Treatments Release: Clinically Validated Tinnitus Treatment Gets FDA Clearance 11/29/2016
Dilon Diagnostics and GE Healthcare Win FDA Clearance of the Discovery NM 750b Biopsy Accessory 11/28/2016
Corsens Medical Announces Clearance of a 510(K) Pre-Marketing Notification With The FDA for the Corsens Cardiac Monitor 11/28/2016
International Biophysics' AffloVest Wins CE Mark Approval for Use in Europe and Elsewhere 11/28/2016
Exact Imaging Snags CE Mark Nod for Its ExactVu Prostate Imaging And Biopsy Micro-Ultrasound System 11/23/2016
QView Medical Announces FDA PMA Approval For QVCAD, The First Computer Aided Detection (CAD) System For 3D Automated Breast Ultrasound Screening 11/23/2016
Spectranetics (SPNC) Nabs CE Mark for Stellarex 0.014” Drug-Coated Balloon 11/22/2016
Allergan (AGN) Wins FDA Nod for the XEN Gel Stent, a New Surgical Treatment for Refractory Glaucoma 11/22/2016
SuperSonic Imagine Receives FDA 510(k) Clearance For Its New Innovative Breast And Liver Package On Aixplorer 11/22/2016
Lipogems Announces New FDA Clearance 11/22/2016
Ascensia Diabetes Care Wins FDA Nod for App-Enabled Contour Next One Blood Glucose Monitoring System 11/21/2016
Medizone Release: AsepticSure Hospital Disinfection System Achieves EPA Approval For US Market Entry 11/21/2016
Genedrive Announces CE-IVD Certification For Genedrive Human Genotyping Test 11/17/2016
HeartFlow FFRct Analysis Receives Regulatory Approval In Japan 11/17/2016
Xenocor Release: Xenoscope, the Revolutionary Cost-Effective Laparoscope Receives CE Mark 11/17/2016
FDA Green Lights INOVA Diagnostics' New Inflammatory Bowel Disease Test 11/16/2016
Medtronic (MDT)'s Solitaire Stent Retriever Device Wins Expanded Nod From the FDA 11/16/2016
ZDi Solutions, LLC Receives FDA Approval for Patented Proton Therapy & Conventional Radiation Therapy Positioning Devices 11/16/2016
Xtant Medical Snags FDA Nod to Use Allografts in the Stand-Alone Irix-C Cervical Cage 11/15/2016
FDA Green Lights Medtronic (MDT)'s 'Smart' Defibrillator for Heart Patients 11/15/2016
Ignyta (RXDX) Announces EAP Designation And CE Marking For Its Trailblaze Pharos Clinical Trial Assay 11/15/2016
InspireMD Announces CGuard Embolic Prevention System Commercialization Approval In Russia 11/15/2016
LimFlow Receives CE Mark For Purely Percutaneous Critical Limb Ischemia (CLI) Technology Designed To Restore Perfusion For “No Option” Patients 11/15/2016
FDA Clears CapsoVision's CapsoCam Plus 11/14/2016
Medtech Startup KATOR Wins FDA Nod for Knotless Suture Anchor System 11/9/2016
FDA Clearance For jioima Vaporflex And Legato Electrosurgical Probes 11/9/2016
Integrity Applications Incorporated Release: GlucoTrack Maker Announces Receipt Of Final Regulatory Approval In South Korea 11/8/2016
Medinol Ltd. Receives Approval From The Japanese PMDA To Begin Clinical Study On Novel DES 11/8/2016
FDA Green Lights Propeller Health's Sensor for GlaxoSmithKline (GSK) Ellipta Inhaler 11/7/2016
FDA OKs Roche (RHHBY)'s VENTANA ALK (D5F3) CDx Assay 11/7/2016
Myriad Genetics (MYGN) Will Seek Japanese Regulatory Approval For BRACAnalysis CDx 11/7/2016
St. Jude Medical (STJ) Gains CE Mark Approval For MRI Labeling Of Its Quadra Allure MP Cardiac Resynchronization Therapy Pacemaker 11/7/2016
EOS Imaging Receives FDA 510(K) Clearance For kneeEOS 3D Surgical Planning Software For Total Knee Arthroplasty 11/7/2016
Abbott (ABT)'s Absorb Bioresorbable Stent Approved As The First Fully Dissolving Heart Stent In Japan 11/7/2016
Advanced Accelerator Applications Announces Swiss Marketing Authorization For Two PET Diagnostic Products 11/2/2016
Arterys Receives 510(K) Clearance For Arterys Software For Cloud-Based Medical Image Visualization And Quantification 11/2/2016
Telehealth Startup Tyto Care Wins FDA Approval for Digital Telemedicine Stethoscope 11/1/2016
Neural Analytics Nabs FDA Approval for Brain Monitoring Information System 11/1/2016
Exalenz Bioscience Receives FDA Marketing Clearance for its Laboratory System in the United States 11/1/2016
Neuraceq Automated Synthesizer Synthera (Neuraceq Synthera) Received Shonin Approval In Japan 11/1/2016
AtriCure (ATRC) Announces Approval For The cryoICE Platform In Japan 11/1/2016
FDA OKs St. Jude Medical (STJ)'s New Device for Prevention of Recurrent Strokes in Certain Patients 10/31/2016
Onkos Surgical Wins FDA Approval for ELEOS Limb Salvage System 10/31/2016
Transseptal Solutions Announces CE Mark For A New Steerable Sheath With A Novel Approach For Transseptal Puncture And Left Atrial Navigation 10/31/2016
FDA Green Lights Corindus Vascular Robotics' Next Generation Robotic System 10/28/2016
Roche (RHHBY) Announces FDA Approval for VENTANA PD-L1 (SP142) Assay to Support Immunotherapy Treatment Decisions In Lung Cancer 10/27/2016
Medtronic (MDT) Announces FDA Approval Of New Recaptureable TAVR System Available For Severe Aortic Stenosis Patients With Large Anatomies 10/27/2016
PathoQuestAchieves CE Mark For The iDTECT Blood Test 10/27/2016
Bay Area's BioTrace Medical Nabs FDA Clearance of Innovative Temporary Pacing Technology for the Heart 10/27/2016
Teleflex Inc. (TFX) Announces European Market Clearance For Its Arrow VPS Rhythm System 10/26/2016
RTI Surgical (RTIX) Announces Additional 510(k) Clearance for the Streamline OCT System 10/26/2016
Medtronic (MDT) Nabs FDA Clearance for New Lower Profile HawkOne 6F Directional Atherectomy System 10/25/2016
Ethicon (JNJ) Release: EVARREST Fibrin Sealant Patch Gains FDA Approval on Expanded Indication for General Hemostasis 10/25/2016
FDA Green Lights Spineology Inc.'s Rampart Duo Interbody Fusion System 10/25/2016
Bio-Rad (BIO) Nabs FDA Nod for Its IH-1000 Blood Typing Instrument 10/24/2016
Roche (RHHBY) Wins FDA Approval for Cobas MPX Test 10/24/2016
FDA Clears Ortho Clinical Diagnostics' ORTHO VISION Max Analyzer for High-Volume Transfusion Medicine Labs 10/24/2016
JARVIK HEART, Inc. Receives FDA Approval For Clinical Trial Of Miniature Heart Assist Device For Infants And Children 10/24/2016
MEDICREA Wins FDA Nod Clearances of Two New Specialized Components for Pediatric Deformity on PASS And Ligapass Platforms 10/21/2016
FDA Green Lights Colorado Therapeutics' Novel Xenograft Implant for Soft Tissue Repairs 10/21/2016
Avita Medical Release: U.S. FDA Approves Increased Compassionate Use Patient Cases And Sites For ReCell In Life-Threatening Injuries 10/19/2016
CollPlant Receives CE Mark For VergenixSTR For Treatment Of Tendinopathy 10/19/2016
neoSurgical Limited Announces CE Mark Approval Of The neoClose Laparoscopic Port Closure Device 10/18/2016
Teleflex Inc. (TFX) Snags FDA Green Light for the Arrow Midline with Chlorag+ard Technology 10/17/2016
Nuvo Pharma Receives Approval From German Regulatory Authorities To Conduct Pennsaid 2% Phase 3 Trial For Treatment Of Acute Ankle Sprains 10/17/2016
FDA Approves Genentech (RHHBY)'s Lucentis Pre-Filled Ranibizumab Syringe 10/17/2016
Merz Aesthetics (Formerly Known as BioForm Medical, Inc.) Announces Three Year FDA Clearance For Cellfina System 10/17/2016
Admedus Vascucel Receives FDA Clearance For Launch In November 10/17/2016
Medrobotics Receives Expanded CE Mark For Flex Robotic System 10/17/2016
Medtronic (MDT) Bagged FDA Approval for Its MRI-compatible Heart Failure Devices 10/14/2016
Royal Philips Electronics N.V. (PHG) Receives FDA Clearance For Lumify's S4-1 Transducer Bringing New Capabilities, Including Cardiac Imaging, to This Smart-Device Ultrasound 10/14/2016
BTG plc (BTG.L) And Mirada Medical Announce CE Mark Certification For Simplicit90Y Dosimetry Software In Europe 10/14/2016
Spineology Inc. Interbody Devices Now FDA Approved With Allograft Bone 10/11/2016
Teleflex Medical Nabs FDA Clearance for ARROWJACC with Chlorag+ard Technology and Tunneler 10/10/2016
US FDA Grants Approval For LBT's APAS 10/10/2016
St. Jude Medical (STJ) Snags FDA Green Light and Launch of the New PressureWire X Guidewire 10/10/2016
Clever Culture Systems AG Release: U.S. FDA Grants Approval For LBT's APAS 10/10/2016
Adapta Medical's User-Friendly Urinary Catheter Gets FDA Clearance 10/7/2016
Viveve Snags FDA Nod for the Viveve System in the U.S. 10/7/2016
Fresenius Kabi AG Receives FDA 510(k) Clearance for the Aurora Xi Plasmapheresis System 10/7/2016
Masimo (MASI) Announces CE Marking Of Rad-97 Pulse CO-Oximeter 10/6/2016
Trice Medical Win FDA Nod for MI-Eye 2 10/6/2016
BioGX Receives CE-IVD Mark For Influenza A, B And Respiratory Syncytial Virus Assay On The BD MAX System 10/6/2016
Siemens (SI) Wins FDA Nod for Xprecia Stride Coagulation Analyzer 10/5/2016
RA Medical Systems, Inc. Receives Approval In Europe For DABRA Atherectomy And Pharos Laser Phototherapy Systems 10/5/2016
Etiometry Receives FDA 510(K) Clearance On Its First Algorithm, The IDO2 Index Powered By Risk Analytics For Neonates 10/4/2016
St. Jude Medical (STJ)'s BurstDR Wins FDA Approval for Chronic Pain 10/4/2016
Owlstone Medical Receives CE Mark Approval For Pediatric Disease Breathalyzer 10/4/2016
Edwards Lifesciences (EW) Receives CE Mark For Hypotension Probability Indicator 10/3/2016
Profusa Receives CE Mark To Market The Lumee Oxygen Platform For Continuous, Real-Time Monitoring Of Tissue Oxygen 10/3/2016
Jubilant Draximage Receives FDA Approval For RUBY-FILL Rubidium 82 Generator And Elution System 10/3/2016
ProAxsis Gains CE Mark For Active Neutrophil Elastase Immunoassay 9/30/2016
Medtronic (MDT) Nabs FDA Nod for World's First Artificial Pancreas for Diabetes 9/29/2016
Edwards Lifesciences (EW) INSPIRIS RESILIA Valve Receives CE Mark 9/29/2016
Roche (RHHBY) Release: Harmony Prenatal Test For Assessment Of Down Syndrome And Other Chromosomal Disorders Receives CE Mark 9/29/2016
FDA Clears Becton, Dickinson and Company (BDX) s Next Generation Blood Collection and Separation Technology 9/29/2016
Medtronic (MDT) Snags FDA Nod for TrailBlazer Angled Peripheral Support Catheter 9/28/2016
Soterix Medical Launches PainX tDCS Treatment In Canada With Health Canada Approval 9/28/2016
Abbott (ABT) Wins FDA OK for the FreeStyle Libre Pro System, a Revolutionary Diabetes Sensing Technology for Healthcare Professionals to Use With Their Patients 9/28/2016
BrainScope Nabs FDA Win for First Handheld Medical Device for Traumatic Brain Injury 9/26/2016
Allergan (AGN) Wins FDA Approval of NATRELLE INSPIRA Cohesive Breast Implants 9/26/2016
Oventus Receives FDA Clearance For The O2VentTM T 9/26/2016
Roche (RHHBY) Receives 510(K) Clearance From FDA For Treponema Pallidum Assay To Aid Clinicians In The Diagnosis Of Syphilis Infection 9/26/2016
NovaBone Products Secures Approval of CE Mark For Collagen Devices 9/26/2016
STAAR Surgical (STAA) Announces Approval By Health Canada Of Its EVO Visian ICL Toric Lens Specifically Designed For The Nearsighted Patient With Astigmatism 9/23/2016
FDA Clears Global Kinetics's Parkinson’s Kinetigraph, A Wrist-Worn Device for 24/7 Monitoring of Parkinson’s Disease Patients 9/22/2016
GI View Snags FDA Nod for Aer-O-Scope Disposable Colonoscope 9/21/2016
FDA Green Lights Life Spine's PRO-LINK Ti Stand-Alone Cervical Spacer System 9/21/2016
FDA Approves Components for K2M'’s Mesa Spine Implant 9/21/2016
Heidelberg Engineering Receives FDA Clearance To Market SPECTRALIS OCT Glaucoma Module Premium Edition 9/21/2016
FDA Clears NuVasive (NUVA)'s MAGEC System to be Surgically Implanted Using Its Reline Posterior Fixation System 9/19/2016
FDA Green Lights Bayer (BAY)'s Five-Year Contraceptive Kyleena 9/19/2016
ViewRay Receives CE Mark Approval For Its MRIdian Linac System 9/19/2016
Standard Textile Release: FDA-Cleared Bed Linens Engineered to Reduce Development of Pressure Ulcers 9/19/2016
Boston Scientific (BSX) Receives CE Mark For LOTUS Edge Valve System 9/19/2016
SpeeDx Receives CE-IVD Mark For ResistancePlus MG 9/19/2016
Riverain Technologies Release: FDA Clears Way For ClearRead CT Software 9/19/2016
UCB, Inc. (UCBJF.PK) Receives EMA Regulatory Approval For Pre-filled Pen With Core Bespak Technology 9/19/2016
RTI Surgical (RTIX) Receives Regulatory Clearances, Expands Distribution Of Nanoss Bioactive In Australia, Europe 9/19/2016
Medeon Biodesign Wins FDA OK for Abclose - Laparoscopic Port Site Closure Device 9/19/2016
Boston Scientific (BSX) Joins $10 Million Funding Round for Securus Medical 9/16/2016
FDA Clears Shockwave Medical's Lithoplasty System, the First-Ever Device That Uses Sound Waves for Peripheral Artery Disease 9/16/2016
FDA Approves the MED-EL's SYNCHRONY EAS Hearing Implant System 9/16/2016
FDA Clears Varian Medical Systems (VAR)'s Nexus DR Digital X-Ray Imaging System 9/15/2016
Carl Zeiss Meditec AG (AFX.DE) Receives US FDA Approval For VisuMax SMILE Vision Correction Procedure, The Latest Advancement In Laser Eye Surgery 9/15/2016
FDA Clears Medtronic (MDT)'s First Drug-Coated Balloon for In-Stent Restenosis (ISR) 9/14/2016
FDA Approves Kerecis's Omega3-Rich Fish Skin for Surgical Applications 9/14/2016
FDA Gives Nod to Carl Zeiss Meditec AG (AFX.DE) Visumax Femtosecond Laser to Surgically Treat Nearsightedness 9/14/2016
Brainsway (BRSYF.PK) Attains Regulatory Approval for Marketing Deep TMS In Mexico 9/14/2016
Medtronic (MDT) Announces Approval And Launch Of Reveal LINQ Insertable Cardiac Monitor In Japan 9/14/2016
Starpharma Release: VivaGel Condom Receives Regulatory Approval In Canada 9/13/2016
NeuroMetrix (NURO) Reports Final Approval To Market DPNCheck In China 9/13/2016
Obalon Wins FDA Approval of Obalon Balloon System 9/12/2016
Datum Dental's New Collagen Scaffold, OSSIX VOLUMAX, Nabs FDA Clearance 9/12/2016
NovaBay (NBY)’ Neutrox Product Line Receives CE Mark And ISO Certification For The European Union 9/12/2016
SyntheticMR AB: MAGiC Receives FDA Approval 9/9/2016
Sight Sciences Announces CE Mark Approval For And Successful Commercial Experiences With The VISCO360 Viscosurgical System For The Surgical Treatment Of Glaucoma 9/9/2016
FDA Clears Icometrix' Image Quantification Software To Monitor Neurological Disorders 9/9/2016
ViewRay Receives Chinese Regulatory Approval For Its MRIdian System 9/9/2016
Additive Orthopaedics Wins FDA Clearance for Its 3D Printed Osteotomy Wedge System 9/8/2016
Monteris Med Receives IDE Approval From FDA To Evaluate NeuroBlate In Patients Newly Diagnosed With Glioblastoma Multiforme 9/8/2016
Carestream Health’s OnSight 3D Extremity System Receives FDA 510(k) Clearance 9/8/2016
OrthoSera Receives CE Mark For hypACT Device To Regenerate Osteoarthritic Bone 9/7/2016
BlueWind Medical Announces CE-Mark For The BlueWind VIVENDI Miniature Implanted Wireless Stimulator To Treat Peripheral Pain 9/7/2016
Cepheid (CPHD)'s Xpert TV Now Cleared for Testing Symptomatic and Asymptomatic Men 9/7/2016
Cochlear Limited Unveils Kanso, A First-Of-Its-Kind Hearing Technology To Treat Severe To Profound Hearing Loss 9/6/2016
WOUNDCHEK Protease Status Receives Market Clearance In Australia 9/6/2016
FDA Green Lights Medtronic (MDT)'s Enlite Continuous Glucose Sensor 9/1/2016
Spirometrix, Inc. Receives CE Mark For Its Fenom PRO Point-Of-Care Breathalyzer 8/31/2016
Bluegrass Vascular Wins CE Mark Approval and Announces Successful Commercial Use of The Surfacer Inside-Out Access Catheter System 8/30/2016
Apira Science’s iGrow Becomes First Wearable Laser Device To Be Cleared By ANVISA In Brazil 8/30/2016
Fortimedix Surgical Nabs FDA Nod for Innovative Single-Port Surgical Platform 8/29/2016
Oculus Innovative Sciences (OCLS) Wins FDA Nod for New Post-Dermal-Procedures Product for Removal of Foreign Material Including Microorganisms 8/24/2016
FDA Approves BiO2 Medical's Angel Catheter, the First Ever Prophylactic Use Indication for a Medical Device for Pulmonary Embolism 8/24/2016
Amedica Corporation Receives FDA Clearance For Additional Valeo II Lateral Lumbar Interbody Fusion Device Offerings 8/24/2016
ImPACT Is the First Concussion-Specific Medical Device to Receive FDA Clearance 8/23/2016
FDA Green Lights Cochlear Limited's Nucleus MRI-Safe Hearing Aid 8/23/2016
Alere (ALR) Nabs FDA Clearance for Alere i RSV Rapid Molecular Test 8/19/2016
Cianna Medical Wins Additional FDA Clearance for SAVI SCOUT Radar Localization System 8/18/2016
Quidel Corporation (QDEL) Grabs FDA Approval for Its Solana Trichomonas Assay for Diagnosis of Trichomoniasis 8/18/2016
Masimo (MASI) Announces CE Marking For RAS-45 Sensor For Rainbow Acoustic Monitoring Of Respiration Rate 8/18/2016
Levita Magnetics' Magnetic Surgical System Wins FDA Clearance 8/17/2016
Merz North America Acquires Aesthetics Medical Device Company ON Light Sciences 8/16/2016
Bovie Medical Corporation (BVX) Receives FDA 510(k) Clearance for Its PlazXact Ablator 8/16/2016
Centric Medical Announces FDA Clearance of TARSA-LINK Bunion System 8/16/2016
DT MedTech Secures CE Marking And begins Active Distribution Of Hintermann Series H3 Lower Extremity Medical Devices 8/16/2016
ViewRay's MRIdian System Receives Japanese Regulatory Approval (Shonin) 8/15/2016
FDA Approval for Edwards Lifesciences Corporation (EW)’s Intuity Elite Rapid Deployment Valve 8/15/2016
Oculus Innovative Sciences (OCLS) Receives Australian Approvals To Market Sterile Microcyn-Based Antimicrobial Solutions And Hydrogel Dressings 8/11/2016
Medtronic (MDT) Nabs CE Mark for Deep Brain Stimulation Therapy Software 8/10/2016
FDA Clears Boston Scientific (BSX)'s EMBLEM MRI S-ICD System 8/9/2016
Accuray Inc. (ARAY) CE Marks Its New Radixact System 8/9/2016
Alere (ALR) Achieves IVD CE Mark For Its Alere Reader Lateral Flow Assay Analyzer 8/9/2016
Medical Compression Systems Release: FDA Approves the Next Generation ActiveCare 8/9/2016
DeGen Medical Snags FDA Clearance of CONNECT-L Transverse Connector with F1 MPS System 8/8/2016
ReShape Medical Names Former Sirtex Medical (SRX.AX) Exec as New CEO 8/8/2016
Medtronic (MDT) Receives CE Mark For SureTune2 For Deep Brain Stimulation Therapy 8/8/2016
Inseal Medical Announces CE Mark Approval For The InClosure Large Bore Vascular Closure Device 8/8/2016
POP Medical Solutions Wins FDA Nod for Pelvic Device 8/8/2016
RevMedx Wins FDA Clearance of XSTAT 12 8/5/2016
Masimo (MASI) Wins CE Marking for Pediatric O3 Regional Oximetry 8/4/2016
EndoChoice Nabs FDA Clearance for Lumos With Adaptive Matrix Imaging 8/4/2016
Luminex (LMNX) Wins FDA Nod for New Molecular Test for Influenza A/B And RSV Assays 8/3/2016
FUJIFILM Announces 510(k) Clearance of FDR Visionary Suite and the Release of FDR Clinica X-Ray Components 8/3/2016
W. L. Gore & Associates Snags FDA Nod for Tigris Vascular Stent 8/2/2016
Shire (SHPG) Wins FDA Approval of Adynovate with BAXJECT III Reconstitution System 8/1/2016
Medtronic (MDT) CoreValve Evolut R System First TAVI To Receive CE Mark For Intermediate Risk Aortic Stenosis Patients 8/1/2016
Thermo Fisher Scientific (TMO) Release: New Immunoassay For The Specific Detection Of Hydrocodone Receives FDA 510 (K) Clearance 8/1/2016
Thermo Fisher Scientific (TMO) Receives FDA Clearance for EliA Anti-Thyroglobulin and Anti-Thyroid Peroxidase Tests for Autoimmune Thyroid Disease 8/1/2016
Micro Interventional Devices Receives FDA Market Clearance for Permaseal 7/29/2016
FDA OKs SPR Therapeutics' Pain Management Device 7/28/2016