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Medical Dev. & Diag. - Approvals
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
4WEB Medical Announces FDA Clearance Of Lateral Spine Truss System 7/28/2016
Companion Medical Receives FDA Clearance for Smart Insulin Delivery System 7/28/2016
Orthofix International NV (OFIX) Announces Japanese Approval And Market Launch Of PHOENIX Minimally Invasive Spinal Fixation System 7/28/2016
FDA Clears Expanded Indication For Itamar Medical Inc.'s WatchPAT Sleep Apnea Diagnostic Device For Adolescents 7/27/2016
DeGen Medical Wins FDA Clearance of F1 MPS System for JOUST Minimally Invasive Surgical Procedure 7/27/2016
Cynosure (CYNO) Receives Approval To Market SculpSure In South Korea 7/26/2016
Instrumentation Laboratory Company Wins FDA Nod for New HemosIL HIT-Ab(PF4-H) Assay 7/26/2016
Tandem Diabetes Care Announces Expanded Pediatric Indication Of T:Slim Insulin Pump For Ages 6 And Older 7/26/2016
Syneron Candela's PicoWay Picosecond Laser Snags FDA Approval for Ultra-Short 785nm Wavelength 7/25/2016
Asuragen, Inc.'s QuantideX qPCR BCR-ABL IS Kit Receives FDA Premarket Clearance For Monitoring Minimal Residual Disease In Chronic Myeloid Leukemia 7/25/2016
LifeBond Receives FDA IDE Approval For LifeSeal GI Surgical Sealant Clinical Trial 7/21/2016
Vasorum Snags FDA Approval for Celt ACD Vascular Closure Device 7/21/2016
Cydar Limited Gains FDA Nod for Revolutionary 3D Surgical Guidance Software 7/21/2016
FDA Green Lights Relievant Medsystems' INTRACEPT for Chronic Low Back Pain Relief 7/21/2016
Medtronic (MDT) Receives First-Ever FDA Clearance For Cement-Augmented Pedicle Screws 7/20/2016
Medtronic (MDT) Nabs CE Mark Approval for Its Continuous Glucose Monitoring (CGM) System 7/19/2016
Syneron Candela Nabs FDA Clearance of High Energy UltraShape Power for Fat Destruction 7/18/2016
FDA Green Lights Abbott (ABT)'s Tecnis Symfony Lens for Cataracts 7/18/2016
Medtronic (MDT) Receives FDA Approval for Two-Level Prestige LP Cervical Disc Procedures 7/18/2016
Essential Medical Announces CE Mark Approval For The MANTA Large Bore Vascular Closure Device 7/18/2016
Health Canada Clears Abbott (ABT)'s Absorb Bioresorbable Stent 7/15/2016
Soberlink's Breathalyzer Nabs FDA Clearance for Medical Use 7/15/2016
Medifirst Solutions' "The Time Machine" Series Laser Wins 510(k) FDA Clearance 7/15/2016
Tandem Diabetes Care Wins FDA Clearance of Remote Software Update Tool for Insulin Pumps 7/14/2016
NovoCure Snags FDA Approval for Second Generation Optune System 7/14/2016
Medtronic (MDT) Gets FDA Nod for IN.PACT Admiral DCB 150 mm Lengths 7/13/2016
SinuSys Nabs FDA Clearance for the Vent-Os Sinus Dilation Family of Devices 7/13/2016
FDA OKs Analytica Limited's PeriCoach Pelvic Floor Trainer for Sale OTC in the U.S. 7/13/2016
FDA Clears InSightec's Focused Ultrasound Brain Device 7/12/2016
Vision Research Unveils The Phantom VEO® Family Of High-Speed Cameras 7/12/2016
Alafair Biosciences Receives FDA 510(k) Clearance for VersaWrap Tendon Protector 7/12/2016
bioLytical™ Laboratories Receives CE Mark For HIV Self-Testing Kit 7/11/2016
FDA Clears Expanded Indications For Medtronic (MDT) NuVent EM Sinus Dilation System With Image Guidance 7/11/2016
Roche (RHHBY) Wins FDA OK for Use of Surepath Preservative Fluid with Cobas HPV Test for Cervical Cancer Screening 7/8/2016
QT Vascular Receives CE Mark Clearance For Chocolate Heart, A Novel Drug-Coated Coronary Balloon 7/7/2016
ndd Medical's EasyOne Pro And EasyOne Pro LAB First Mobile PFT Devices To Receive Regulatory Approval In Japan 7/7/2016
Cardiovascular Systems Submits Diamondback 360 Coronary Orbital Atherectomy System Micro Crown For Approval In Japan 7/7/2016
Luminex (LMNX) Snags FDA Clearance and CE-IVD Mark for the ARIES M1 System 7/6/2016
Prism Medical & Design Earns FDA Clearance For Its ProteXsure Safety Capsule System- Looks To Add International Distributors 7/6/2016
Immuno Concepts' Image Navigator Automated Microscope Receives FDA 510(K) Clearance 7/6/2016
Ethicon (JNJ) HARMONIC HD 1000i Shears Receives U.S. FDA 510(k) Clearance 7/5/2016
TSO3 (TOS) Receives U.S. Clearance For Extended Claims For Its Breakthrough Medical Device Sterilizer 7/5/2016
Abbott (ABT) Wins FDA Nod for Absorb Stent 7/5/2016
Cartiva Announces FDA Premarket Approval For Cartiva Synthetic Cartilage Implant 7/5/2016
Sparo Labs Gets FDA Clearance For Lung Measuring Device 6/30/2016
FDA Approves ReVision Optics, Inc.'s Implantable Device That Changes The Shape Of The Cornea To Correct Near Vision 6/30/2016
Concordia International Corp. Announces FDA Approval For New Photofrin Laser 6/30/2016
FDA Clears Cepheid (CPHD)'s First Test To Detect Specific Genetic Markers For Certain Antibiotic-Resistant Bacteria Directly From Clinical Specimens 6/30/2016
Baxter International (BAX) Announces Health Canada Approval Of AMIA Automated Peritoneal Dialysis System With SHARESOURCE Connectivity Platform 6/29/2016
AtriCure (ATRC) Receives CE Mark For The AtriClip PRO2 Device 6/29/2016
JustRight Surgical to Receive FDA Clearance for Use of Device in Pediatric Patients 6/29/2016
SRS Medical Systems Receives CE Mark Approval for Spanner Prostate Stent 6/29/2016
SpeeDx Receives CE-IVD Mark for PlexPCR HSV-1&2, VZV Kit 6/29/2016
MGC Diagnostics Corporation Receives FDA 510(K) Clearance For Resmon PRO FULL, Forced Oscillation Technique (FOT) Device 6/28/2016
Masimo (MASI) Announces FDA 510(K) Clearance For Radius-7 With rainbow Technology, Including Continuous SpHb 6/28/2016
CorMatrix Cardiovascular CanGaroo ECM Envelope Receives CE Mark Approval 6/28/2016
NDS Surgical Imaging Receives FDA Clearance For Embedded Wireless Video Receiver In Radiance Ultra Displays 6/27/2016
Accuray Inc. (ARAY) Receives 510(K) FDA Clearance For The Radixact Image-Guided Radiation Therapy Platform And Integrated Software 6/27/2016
QT Vascular Receives FDA 510(k) Clearance For Chocolate XD, A Novel PTCA Balloon 6/27/2016
Life Spine's Centric Medical Wins FDA Clearance for Flatfoot Implant 6/24/2016
Centinel Spine Granted Australian Clearance For STALIF L Minimally-Invasive, Lateral Integrated Interbody System 6/23/2016
St. Jude Medical (STJ) Expands Its Heart Failure Portfolio With Syncav CRT Technology, Providing Physicians Another Option For Managing Patients Not Responsive To Other Therapies 6/23/2016
Roche (RHHBY) Receives FDA Clearance For Its Procalcitonin (PCT) Assay To Help Clinicians Effectively Assess Sepsis Risk And Manage Sepsis Patients 6/23/2016
Integrated Device Technology Release: Implantable Glucose Sensor Featuring IDT Sensing Technology Awarded CE Mark 6/22/2016
OstomyCure AS Release: Significant Breakthrough for Stoma Patients 6/22/2016
Ortho Clinical Diagnostics Receives CE Mark Approval For VITROS Immunodiagnostic HIV Combo Test 6/21/2016
Polyganics Announces CE Mark For NEUROCAP, The Nerve Capping Device For Treatment And Prevention Of Symptomatic Neuroma 6/21/2016
Boston's REBIScan Snags FDA Approval for Pediatric Vision Scanner 6/17/2016
SpineGuard Wins FDA Clearance to Market PediGuard Threaded DSG Device 6/17/2016
BlueWind Medical Announces CE-Mark For The First In The World Miniature Wireless Neurostimulator To Treat Overactive Bladder 6/16/2016
Tyber Medical Expands FDA 510(k) Clearance Of Headed And Snap-Off Screws 6/15/2016
Protagen AG Announces CE Mark For Its Proprietary Multilisa® BICD2 Test For Better Diagnosis Of Systemic Sclerosis 6/15/2016
FDA Clears Aspire Bariatrics' Weight-Loss Stomach Tube Device 6/15/2016
Masimo (MASI) Snags FDA Approval for O3 Regional Oximetry 6/13/2016
SI-BONE Wins FDA Clearance for Updated Indication for the Ifuse Implant System 6/13/2016
Bay Area's Sandstone Diagnostics Wins FDA Nod for the Trak Male Fertility Testing System 6/10/2016
Endocure Technologies, Inc., A Wholly Owned Subsidiary Of MedServ Technologies, Inc., Has Received FDA 510(k) Clearance For The Manufacture Of Its New Endocure Model EUR078A Urology Endoscope 6/10/2016
Astute Medical Receives FDA Clearance For NephroCheck Test Improvements Extending Shelf Life 6/9/2016
GenMark Diagnostics (GNMK) Achieves CE Mark For Its Eplex Sample-To-Answer System 6/9/2016
MX Orthopedics Receives FDA Clearance On The dynaM Nitinol Compression Screw 6/8/2016
Stentys Announces CE Marking Of Its Longest Xposition Stent 6/8/2016
Micro Interventional Devices, Inc. Receives CE Mark Approval For Permaseal 6/7/2016
Merz Aesthetics (Formerly Known as BioForm Medical, Inc.) Receives CE Mark For Radiesse (+) Lidocaine 6/7/2016
FDA Clears A New Latex Condom By O-RING Products With The Technology To Ease And Improve The Application Of Condoms 6/7/2016
Axonics Modulation Tech Receives CE Mark For Its Sacral Neuromodulation System For The Treatment Of Urinary And Fecal Dysfunction 6/6/2016
FDA Clears Cerêve Device For Treating Insomnia Patients By Helping Them Get To Sleep Faster 6/6/2016
Esco Tech Secures FDA Clearance for Miri TL, a Proprietary Next-GenTime-Lapse Embryo Incubator for IVF 6/2/2016
Occlutech Obtains European CE Mark Approval For Its LAA Occluder 6/2/2016
First Ray Receives FDA 510(k) Clearance For SpeedButton Soft Tissue Attachment System 6/2/2016
FDA Grants First Liquid Biopsy Approval To The Roche (RHHBY) cobas EGFR Mutation Test v2 6/2/2016
W. L. Gore & Associates Release: GORE EXCLUDER Conformable AAA Endoprosthesis Obtains CE Mark 6/2/2016
Advanced Accelerator Applications Applications Announces FDA Approval of NETSPOT (Somakit-TATE), a Kit for the Preparation of Gallium Ga 68 Dotatate for Neuroendocrine Tumor Detection 6/2/2016
Additive Orthopaedics Nabs FDA Nod for Their 3D Printed Digital Fusion Implant For The Global Extremities Market 6/2/2016
Luminex (LMNX) Receives CE-IVD Mark For ARIES Flu A/B & RSV Assay 6/1/2016
Noxilizer Announces FDA 510(K) Clearance of a Medical Device Sterilized Using a Nitrogen Dioxide Process 6/1/2016
Tissuemed Announces TissuePatch Approval In China 6/1/2016
Avenu Medical Receives CE Mark Approval For The Ellipsys Vascular Access System 6/1/2016
Janssen-Cilag International NV (JNJ)’s IMBRUVICA (Ibrutinib) Approved By European Commission For Patients With Newly Diagnosed Chronic Lymphocytic Leukaemia 5/31/2016
Spaulding Clinical Research Receives FDA 510(k) Clearance for 12-Lead ECG Device 5/31/2016
FDA Clears Blue Earth Diagnostics's Axumin (Fluciclovine F 18) Injection to Detect Recurrent Prostate Cancer 5/31/2016
Protagen AG Launches First CE Marked Diagnostic Assays Multilisa® CENP-B And Scl-70 For The Diagnosis Of Systemic Sclerosis 5/31/2016
Spaulding Medical Receives FDA 510(k) Clearance For 12-Lead ECG Device 5/31/2016
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
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
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
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



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