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Medical Dev. & Diag. - Approvals
Titan Pharma (TTNP) Receives FDA Approval for the First Ever Implantable Device for Opioid Dependency 5/27/2016
SuperSonic Imagine Receives Regulatory Approval In Japan For New Advancements On The Aixplorer Ultrasound System 5/27/2016
Respiratory Motion, Inc. Receives CE Mark For ExSpiron 5/26/2016
FDA Panel Backs St. Jude Medical (STJ)’s Amplatzer Stroke Device 5/26/2016
Roche (RHHBY) Wins First FDA-Approved CMV Test For Use In Hematopoietic Stem Cell Transplant Recipients 5/25/2016
Mauna Kea Technologies Receives U.S. FDA Clearance for Its Near-Infrared Surgical Miniprobes 5/25/2016
European Union Expands CE Mark Approval To Advanced Cooling Therapy’s Esophageal Cooling Device For 120 Hours Duration Of Use 5/25/2016
Interventional Spine Nabs FDA Clearance of Lordotic Opticage 5/24/2016
FDA Approves Medic Vision SafeCT-29 That Helps Achieve Radiation Safety 5/24/2016
Cynosure (CYNO) Wins FDA Nod to Market New PicoSure Energy Delivery System for Tattoos and Pigmented Lesions 5/24/2016
Perimeter Medical Imaging Receives FDA Clearance for OTIS Optical Tissue Imaging System 5/24/2016
Surgical Specialties' Wins Approval of Expanded Use for Biosentry Track Sealant System in Europe 5/23/2016
Cerus (CERS) Release: Health Canada Approves INTERCEPT Blood System For Plasma 5/23/2016
EndoChoice Announces FDA Clearance Of Its Orca Sterile, Single-Use Air/Water And Suction Valves 5/23/2016
Roche (RHHBY) Wins FDA Nod for Novel PD-L1 Biomarker Assay 5/19/2016
Boston Scientific (BSX) Snags FDA Win for Precision Montage MRI Spinal Cord Stimulator System 5/19/2016
Millennium Dental Technologies, Inc. Receives First-of-Its Kind FDA Clearance For Tissue Regeneration 5/17/2016
Ascensia Diabetes Care Receives CE Mark For The State-Of-The-Art Contour Next One And Contour Plus One Blood Glucose Monitoring Systems 5/17/2016
First Ray Nabs FDA 510(K) Clearance for CortiClamp Small Bone Fixation System 5/16/2016
Bone Index Receives FDA 510(K) Clearance For The Bindex Point-Of-Care Instrument To Help Physicians In Diagnosing Osteoporosis 5/16/2016
Orthofix International NV (OFIX) Wins FDA Approval of FORZA PTC Interbody Spacer System 5/16/2016
STAAR Surgical (STAA) Announces Approval By Health Canada Of Its EVO Visian ICL For Surgeons And Their Patients In Canada 5/13/2016
Becton, Dickinson and Company (BDX) Expands STI Portfolio With CE Mark for BD MAX Vaginal Panel 5/13/2016
FDA Clears Next-Gen Version of EndoGastric Solutions’ EsophyX Device 5/12/2016
Corvia Medical Announces CE Mark Approval And Enrollment Of First Patients In Randomized Clinical Study 5/12/2016
Senseonics Nabs CE Mark Approval for the Eversense CGM System 5/11/2016
Integra LifeSciences (IART) Wins FDA Nod for Integra Omnigraft Dermal Regeneration Matrix 5/11/2016
Provepharm Receives FDA Approval For Marketing Of Provayblue (Methylene Blue) Injection 5/11/2016
NinePoint Medical Snags FDA OK for Real-Time Targeting on Nvisionvle Device 5/10/2016
CareTaker Medical Release: FDA Approves CareTaker Wireless Remote Patient Monitor For Continuous Non-Invasive Blood Pressure ("cNIBP") And Heart Rate Monitoring Using Patented Finger Cuff Technology 5/10/2016
Irvine Scientific Snags FDA Nod on Vitrification Media for Use With Oocytes 5/9/2016
Signostics Wins FDA Nod for Uscan – The World’s First Smart Mobile-Connected Visualization Device Specialized for Urologic Care 5/6/2016
SentreHEART Receives 510k Approval for the LARIAT XT Suture Delivery Device 5/5/2016
FDA Clears Boston Scientific (BSX)'s Navigation-Enabled Ablation Catheters 5/4/2016
Vigilant Biosciences Receives CE Mark for OncAlert Oral Cancer RAPID Test to Aid in Diagnosis of Oral Cancer 5/4/2016
Acutus Medical Receives CE Mark For The Acqmap 3D High Resolution Imaging And Mapping System 5/4/2016
First Ray Snags FDA 510(k) Clearance for Stealth Staple 5/3/2016
BIOTRONIK Wins FDA Nod for MR Conditional Cardiac Resynchronization Defibrillators 5/3/2016
FDA Green Lights Medtronic (MDT)'s Afib-Detecting Visia ICD 5/2/2016
ZEISS Receives CE Mark Approval For PLEX Elite 9000 Swept-Source OCT 5/2/2016
Synaptive Medical Receives FDA Clearance for Health Informatics Platform 5/2/2016
Boston Scientific (BSX) Snags FDA Nod for ImageReady MR-Conditional Pacing System 4/26/2016
Royal Philips Electronics N.V. (PHG) Receives FDA 510(K) Clearance of CT Imaging Solutions For Lung Cancer Screening To Help Hospitals of All Sizes Drive Earlier Detection And Improve Patient Care Decisions 4/26/2016
AtriCure (ATRC) Wins FDA Clearance for New AtriClip Device 4/26/2016
Intuity Med Wins FDA Approval to Market POGO Automatic Blood Glucose Monitoring System 4/26/2016
MEDICREA Grabs FDA Approval of First Patient-Specific Unid Cervical Rod for Spine Surgery 4/26/2016
Exactech (EXAC) Nabs FDA 510(k) Clearance for Vantage Total Ankle 4/25/2016
Fiagon AG Receives FDA Clearance For ENT Instruments 4/22/2016
Fiagon AG Receives FDA Clearance For Brain Surgery 4/22/2016
W. L. Gore & Associates Excluder Iliac Branch Endoprosthesis Gains Health Canada Approval 4/21/2016
FUJIFILM VisualSonics Announces 510(K) Clearance For The World's First Ultra High Frequency Ultrasound For Humans 4/21/2016
Hologic (HOLX) Wins FDA Clearance, Availability of Affirm Prone Biopsy System 4/21/2016
eNeura Inc. Receives CE Mark Label Extension Expanding Use of SpringTMS to Include Migraine Prevention 4/21/2016
Boston Scientific (BSX) Wins CE Mark For MRI Labeling of Emblem S-ICD Systems 4/20/2016
Oculus Innovative Sciences (OCLS) Grabs FDA Approval for Lasercyn 4/20/2016
Ortho Kinematics Nabs CE Mark Approval for Spinal Motion Analyzer 4/20/2016
Avedro Wins FDA Approval for Photrexa Viscous, Photrexa and the KXL System for Corneal Cross-Linking 4/19/2016
Ortho Kinematics Secures CE Mark Approval To Support International Expansion 4/19/2016
Nevro Wins FDA Nod for New Surgical Leads for the Senza Spinal Cord Stimulation System Delivering HF10 Therapy 4/18/2016
LifeBond Notches CE Marking for LifeSeal Surgical Sealant for GI Procedures 4/18/2016
Fractyl Snags CE Mark Approval for Revita DMR 4/15/2016
Luminex (LMNX) Bags FDA Clearance and CE Mark for SYNCT Software 4/14/2016
Silk Road Medical Wins FDA for Next-Gen ENROUTE Transcarotid NPS 4/14/2016
Epigenomics AG Receives FDA Approval For Epi proColon 4/13/2016
AtriCure (ATRC) Snags 510(K) Clearance for the Cryoform Cryoablation Probe 4/12/2016
BIOTRONIK Announces FDA Approval of BioMonitor 2 Insertable Cardiac Monitor 4/12/2016
ndd Medical’s Easyone Spirometer Is The First PFT Device Approved For New Coal Miner Surveillance Program 4/12/2016
EOS Imaging Receives FDA Approval For Spineeos, Its Online 3D Planning Solution For Spine Surgery 4/12/2016
Profound Medical Receives CE Mark Approval For TULSA-PRO 4/11/2016
Endologix Announces CE Mark For Next-Generation Nellix EndoVascular Aneurysm Sealing System 4/11/2016
FDA OKs Advanced Surgical Concepts' Tissue Container for Laparoscopic Device 4/8/2016
VolitionRX Announces CE Marks for Two NuQ Blood Assays for Detection of Colorectal Cancer 4/7/2016
Monteris Medical, Inc. Receives IDE Approval From FDA To Evaluate NeuroBlate In Patients With Medically Refractory Epilepsy 4/7/2016
Medtronic (MDT)'s Tiny Wireless Pacemaker Wins FDA Approval 4/7/2016
Sysmex Inostics Release: New Liquid Biopsy RAS Testing For Metastatic Colorectal Cancer Patients Now Available For Clinical Practices 4/6/2016
K2M’s MESA Mini And DENALI® Mini Spinal Systems Receive Additional FDA Clearance For Posterior Cervical Spine Fixation 4/6/2016
Omixon Release: Holotype HLA Now CE-IVD In Europe 4/6/2016
Oventus Medical Receives FDA Clearance For Its Sleep Medical Device 4/6/2016
DiCOM grid Announces FDA Approval of Next Generation Cloud PACS and Zero-Footprint Diagnostic Viewer 4/5/2016
Bracco Diagnostics Grabs First Approval by the FDA for Contrast Enhanced Ultrasonography of the Liver for LUMASON 4/4/2016
Ekso Bionics (EKSO) GT Robotic Exoskeleton Cleared by the FDA for Use With Stroke and Spinal Cord Injury Patients 4/4/2016
BioLineRx's Novel Treatment for Non-Surgical Removal of Skin Lesions Wins CE Mark Approval 4/4/2016
CardioFocus's HeartLight System Granted FDA Approval For Treatment of Atrial Fibrillation (AF) 4/4/2016
Aytu BioScience Awarded Health Canada Approval For Its Mioxsys System For Male Infertility 3/31/2016
Medtronic (MDT) Snags Expanded Indication for Pillcam Colon 2 3/31/2016
Millennium Dental Tech Wins FDA Nod for True Regeneration, the World's First for Tissue Regeneration 3/31/2016
Retina Implant AG Secures CE Mark for Wireless Subretinal Implant 3/30/2016
Cepheid (CPHD) Announces European Approval Of Xpert MRSA Next Generation (NxG) Screening Test 3/29/2016
Sonendo Wins FDA 510(k) Clearance for the Next-Gen of the GentleWave System 3/29/2016
St. Jude Medical (STJ) Announces CE Mark Approval and Launch of Expanded Selection of Quadripolar Pacing Leads 3/29/2016
FDA Clears Corindus Vascular Robotics's CorPath Robotic System for Use in Peripheral Vascular Intervention 3/29/2016
Tenex Health Wins FDA Nod for the TX2 MicroTip, Providing A Minimally Invasive Solution For Chronic Tendinosis 3/29/2016
TSO3 (TOS) Receives FDA Clearance for Universal Design of STERIZONE VP4 Sterilizer 3/28/2016
Great Basin Scientific Wins FDA 510(k) Clearance for First Multiplex Panel 3/28/2016
Merit Medical (MMSI) Announces 510(k) Clearance for Corvocet Biopsy System 3/28/2016
Anika Therapeutics (ANIK) Wins CE Mark Approval for Cingal for the Treatment of Pain Associated with Osteoarthritis of the Knee 3/28/2016
Anika Therapeutics (ANIK) Wins CE Mark Approval For Cingal For The Treatment Of Pain Associated With Osteoarthritis Of The Knee 3/28/2016
Glaukos iStent Trabecular Micro-Bypass Stent Approved In Japan 3/28/2016
ZOLL (ZOLL) Receives Approval To Market Intravascular Temperature Management Technology For Sudden Cardiac Arrest In Japan 3/28/2016
Kedrion Receives FDA Approval To Package Koate Double Viral Inactivation (DVI) Antihemophilic Factor (Human) With Mix2Vial Needle-Free Transfer Device 3/28/2016
Bay Area's Intersect ENT Wins FDA Approval of Additional Indication for PROPEL Mini Sinus Implant 3/24/2016
Baxter International (BAX) Completes CE Mark For Expanded Indication Of HEMOPATCH, An Innovative Surgical Patch, In European Union 3/24/2016
ACell Wins FDA Approval for Concurrent Use of its Wound Management Devices 3/23/2016
Great Basin Scientific Receives FDA 510(k) Clearance for Shiga Toxin Direct Test 3/23/2016
FDA Clears Stimwave's Miniature Peripheral Nerve Stimulator (PNS), Providing The Only Full Body Wireless Pain Relief Solution To Market 3/23/2016
Luminex (LMNX) Receives CE-IVD Mark for ARIES System and ARIES HSV 1&2 Assay 3/21/2016
FDA Approves Expanded Use of Roche (RHHBY) Hepatitis C Virus RNA Test as Aid in Diagnosis 3/21/2016
Apira Science’s Igrow Becomes First Hair Growth Device Cleared By China Food And Drug Administration (CFDA) 3/21/2016
Vermillion Announces FDA Clearance of Overa, Second Generation OVA1 Test 3/21/2016
Stentys Announces The CE Marking Of The Self-Apposing Stent For Left Main Coronary Artery Disease 3/21/2016
Olea Medical Receives FDA Clearance For Olea Sphere 3.0 3/21/2016
Opsens Receives FDA 510(K) Clearance For The Optowire II 3/18/2016
FDA 510(k) Clearance Granted To PneumaCare's Ground-breaking Thora-3DI Product For Non-Contact Respiratory Measurement 3/17/2016
Silk Road Medical Announces CE Mark Approval and First Patients Treated With the Next Generation ENROUTE Transcarotid Neuroprotection System 3/16/2016
Edwards Lifesciences (EW) Receives Approval For SAPIEN 3 Valve In Japan 3/16/2016
InfoBionic Receives FDA 510(k) Clearance for MoMe Kardia 3/16/2016
FDA OKs Expanded Use of Cerus (CERS)'s INTERCEPT Blood System 3/16/2016
CardiacAssist Wins FDA 510(k) Clearance for Its TandemLung Oxygenator 3/15/2016
Nemaura Medical Announces Receipt Of Notification Of CE Approval For Its Sugarbeat Continuous Glucose Monitoring System 3/15/2016
Intuitive Surgical (ISRG) Wins FDA Approval for New EndoWrist Stapler 3/14/2016
Boston Scientific (BSX) Snags FDA Approval for Blazer Open-Irrigated Catheter 3/11/2016
St. Jude Medical (STJ) Wins CE Mark Approval of MRI Compatibility for the Nanostim Leadless Pacemaker 3/10/2016
Cochlear Limited Announces FDA Clearance of the First Smart Bone Conduction Solution for People with Significant Mixed Hearing Loss 3/10/2016
FDA Clears Cepheid (CPHD)'s Genetic Test for Drug Resistant "Superbugs" 3/9/2016
Roche (RHHBY) Receives China Food And Drug Administration (CFDA) Approval For The CINtec PLUS Cytology Test To Help Prevent Women From Developing Cervical Cancer 3/8/2016
Life Spine Announces FDA Clearance of PROLIFT Expandable Interbody System 3/8/2016
BioStable Announces CE Mark Approval For The HAART 300 Aortic Annuloplasty Device 3/8/2016
Avita Medical Wins FDA Approval for Increase in Compassionate Use of ReCell Patient Cases 3/7/2016
Becton, Dickinson and Company (BDX) Snags FDA Nod for New Automated Cervical Cancer Screening System 3/7/2016
Gold Standard Diagnostics Receives FDA Clearance for the AIX1000TM System 3/7/2016
Stryker Wins FDA for Tritanium PL Posterior Lumbar Cage 3/4/2016
BioPhotas Announces Additional FDA Wrinkles Clearance For The Celluma 3/4/2016
W. L. Gore & Associates Release: GORE EXCLUDER Iliac Branch Endoprosthesis Gains FDA Approval 3/3/2016
Xtant Medical Receives CE Mark for Its Aranax Cervical Plating System and Irix-A Stand Alone Anterior Lumbar Interbody Fusion Device 3/3/2016
Zimmer Biomet Announces FDA Clearance For Compatibility of Nexel Total Elbow and Comprehensive Segmental Revision System 3/3/2016
Edwards Lifesciences (EW) SAPIEN XT Valve Snags FDA Approval for Pulmonic Procedures 3/2/2016
Reapplix Snags FDA Approval for Its 3C Patch System 3/1/2016
Becton, Dickinson and Company (BDX) Grabs CE Mark for Next-Gen Blood Separation Technology 3/1/2016
Tyber Medical Announces FDA 510(k) Clearance Of BioTy, A Modified Surface Treatment 3/1/2016
Thermo Fisher Scientific (TMO) Announces Expanded FDA Clearance For Its B·R·A·H·M·S PCT Sepsis Biomarker 3/1/2016
Sebia HbA1c Assay Now Has CE Mark For Diagnosis Of Diabetes 3/1/2016
Royal Philips Electronics N.V. (PHG) Receives 510(K) Clearance Of Care Orchestrator, Next Generation Cloud-Based Clinical Management Software For Patients With Sleep And Respiratory Conditions 3/1/2016
CoorsTek Medical Announces FDA 510(K) Clearance For Total Hip System Incorporating Cerasurf-P Implantable Ceramic Components 3/1/2016
EOS Imaging Receives CE Mark For Spineeos Online 3D Surgical Planning Solution For The EOS System 2/29/2016
Bio-Rad (BIO) Announces CE IVD Marking Of Its QX200 Droplet Digital PCR System For Use As An In Vitro Diagnostic 2/26/2016
SHINE Medical Technologies Receives Regulatory Approval: Nuclear Regulatory Commission To Issue Construction Permit 2/25/2016
CollPlant Receives CE Mark for Vergenix FG Wound Filler 2/23/2016
FDA Panel Votes Against Approval Medtronic (MDT)'s Spine Implant 2/23/2016
Boston Scientific (BSX) Wins FDA Approval for Acuity X4 Quadripolar LV Leads 2/23/2016
Boston Scientific (BSX) Bags CE Mark for Eluvia Peripheral Stent 2/22/2016
Medtronic (MDT) Receives CE Mark For Full Line Of Cardiac Resynchronization Therapy-Defibrillators Compatible With MRI Scans 2/22/2016
Medtronic (MDT) Receives FDA Approval For Expanded Indication Trial In Low-Risk Aortic Stenosis Patients 2/22/2016
Mitralign, Inc. Percutaneous Annuloplasty System Earns CE Mark Approval for Functional Mitral Regurgitation 2/22/2016
Integrity Applications Incorporated Release: GlucoTrack Maker Receives New EU Certification 2/19/2016
ScandiDos Wins FDA Approval for Delta4 Discover in U.S. 2/19/2016
FUJIFILM Snags FDA Clearance for Latest Innovation in PACS Technology: Synapse 5 2/18/2016
FDA Approves Medtronic (MDT)'s DBS Therapy for Parkinson's Patients 2/17/2016
FDA Green Lights Masimo (MASI)'s Root with Noninvasive Blood Pressure and Temperature 2/17/2016
Z-Medica Snags Expanded CE Mark for QuikClot 2/17/2016
Becton, Dickinson and Company (BDX) Wins FDA 510(k) Nod for New Blood Collection Device to Help Enhance Patient and Clinician Experience 2/17/2016
St. Jude Medical (STJ) Wins FDA Approval for Its Axium Neurostimulator System for Pain 2/17/2016
Abbott (ABT) Receives Approval In Australia For FreeStyle Libre--The Revolutionary Glucose Monitoring System For People With Diabetes 2/16/2016
Clear Guide Medical Wins FDA Clearance for its SCENERGY Ultrasound-CT Fusion System 2/16/2016
IRIDEX (IRIX) Wins CE Mark for Cyclo G6 Laser System for the Treatment of Multiple Stages of Glaucoma 2/16/2016
Cutera, Inc. (CUTR) Announces Additional Country Regulatory Clearances For enlighten 2/15/2016
Chemence Medical Wins FDA Approval for Exofin Tissue Adhesive 2/15/2016
Zimmer Biomet Announces FDA Clearance for Unite3D Bridge Fixation System 2/12/2016
Optovue, Inc.'s AngioVue Imaging System Receives FDA Clearance 2/12/2016
Guerbet (GBT) Grabs FDA Nod for the OptiOne Single-Head Contrast Delivery System 2/11/2016
Wenzel Spine Snags FDA Approval to Launch VariLift-LX 2/11/2016
FDA Green Lights MX Orthopedics' Dynamx Compression Staple 2/11/2016
Becton, Dickinson and Company (BDX) Snags FDA Approval for Diagnostic Device for HIV/AIDS 2/10/2016
LifeWatch Wins FDA Approval for Its Continuous Vital Signs Monitoring Service 2/9/2016
CorMatrix Cardiovascular Snags FDA Nod for Its Tyke Implantable Device For Neonate And Infant Cardiac Tissue Repair 2/9/2016
NobleStitch EL Receives Approval In Kazakhstan To Treat PFO And To Suture Cardiac Structures 2/9/2016
AXINESIS Obtains CE Mark For REAplan, Its Medical Interactive Rehabilitation Device 2/8/2016
Atlas Genetics Gains CE Approval For First Product 2/8/2016
Osprey Medical Inc. Receives FDA Clearance for Key DyeVert System Claims 2/8/2016
Medtronic (MDT) First to Win FDA Approval for MR-Conditional Cardiac Resynchronization Therapy-Defibrillators 2/5/2016
Abbott (ABT) Scores CE Mark for Freestyle Libre Flash for Kids 2/5/2016
Bracco Diagnostics Wins First FDA Approval for Barium-Based Product Used for Contrast Radiography 2/2/2016
Dynatronics Corporation (DYNT) Receives Approval To Market SolarisPlus Series In Singapore & Peru 2/1/2016
Avioq Obtains Health Canada Approval For Screening Of Cadaveric Organ And Tissue Donors With The Avioq HTLV-I/II Microelisa System, Expands Already Approved Health Canada And CE-IVD Claims 1/28/2016
FDA Green Lights SonarMed's Device for Monitoring Newborns 1/28/2016
Velano Vascular Receives Additional FDA Clearance for Innovative Blood Draw Device 1/27/2016
Polyganics Receives FDA 510(k) Clearance For Nerve Capping Device NEUROCAP 1/26/2016
Quidel Corporation (QDEL) Receives CE Mark For Its New Sofia Fluorescent Immunoassay For Diagnosis Of Pneumococcal Pneumonia And Pneumococcal Meningitis 1/26/2016
Dako (A) Snags Expanded FDA Approval of Complementary Diagnostic Test to Include Melanoma 1/25/2016
entrotech life sciences Release: ChloraDerm Antimicrobial Transparent Film Dressing Receives FDA Clearance For 7-Day Catheter Site Protection Against MRSA And Other Infection-Related Organisms 1/25/2016
K2M Wins CE Mark for Its Next-Gen RHINE Cervical Disc System 1/22/2016
FDA Clears Intuitive Surgical (ISRG)'s Integrated Table Motion for da Vinci Surgical System 1/22/2016
Pelvalon Wins FDA Nod for Second-Gen Non-Surgical Therapy for Women Suffering from Loss of Bowel Control 1/21/2016
Centinel Spine Announces the FDA Clearance and First Implantation of ALTOS 1/21/2016
Eli Lilly (LLY) Release: FDA Approves Humulin R U-500 Kwikpen 1/21/2016
NeuroMetrix (NURO)'s Peripheral Neuropathy Test Approved for China 1/21/2016
Medicines360 and Camargo Pharmaceutical Services Gain FDA Approval for Intrauterine Contraceptive Device 1/19/2016
W. L. Gore & Associates Release: Unique Biomaterial For Hernia Repair Receives FDA 510K Clearance 1/19/2016
AtriCure (ATRC) Announces Approval For The Atriclip In Japan 1/19/2016
Medical Device Firm Advanced Cooling Therapy Receives 510(K) Clearance From FDA For Second Esophageal Cooling Device To Cool And Warm Patients 1/19/2016
HealthMyne Announces FDA Clearance Of Imaging Analytics Package 1/19/2016



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