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Medical Dev. & Diag. - Approvals
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
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
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
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