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Medical Dev. & Diag. - Approvals
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
Cepheid (CPHD)'s Xpert TV Now Cleared for Testing Symptomatic and Asymptomatic Men 9/7/2016
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
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
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