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  News | News By Subject | News by Disease News By Date | Search News
Medical Dev. & Diag. - Approvals
Volcano Corporation Receives FDA Clearance to Market the Eagle Eye(R) Platinum Digital IVUS Catheter 2/9/2010  More...
Synovis Life Technologies, Inc. (SYNO) Receives FDA Marketing Clearance for Flow Coupler(R) 2/8/2010  More...
Novus Scientific Receives FDA Clearance for TIGR(TM) Matrix Surgical Mesh - World's 1st Long-Term Resorbable Synthetic Mesh 2/5/2010  More...
Polymedco: Advanced High Throughput Automated Immunoassay Fecal Occult Blood Test (FIT) System Receives FDA Clearance 2/4/2010  More...
St. Jude Medical (STJ) Announces European Approval of Smaller, Higher Power ICD and CRT-D Devices with New Heart Failure Monitors 2/4/2010  More...
Toshiba America Medical Systems Receives FDA Clearance for Viamo Ultrasound System 2/4/2010  More...
Medicis (MRX) Receives Approval for RESTYLANE(R) and PERLANE(R) With Lidocaine 2/3/2010  More...
Shina Systems Receives U.S. FDA 510(k) Clearance for its 3Di Cloud-based Medical Imaging Advanced (3D/4D) Visualization Solution 2/3/2010  More...
Mesynthes Obtains U.S. FDA 510(k) Clearance for Endoform Dermal Template 2/3/2010  More...
Alphatec Spine Receives CE Mark for its OsseoScrew(TM) Spinal Fixation System and Its GLIF/ ARC(TM) Portal Access System 2/2/2010  More...
Veran Medical Technologies Receives FDA Clearances to Expand Uses for ig4 Navigation System to Use Ultrasound and 3D Fluoroscopic X-ray 2/2/2010  More...
STAAR Surgical Company (STAA)'s Visian(R) ICL(TM) is First Phakic Lens to Be Approved in Japan 2/2/2010  More...
RSB Spine Announces FDA Clearance for Its InterPlate(TM) C-PS and L-PS Interbody Spacers 1/29/2010  More...
Aubrey Inc. Receives FDA Clearance for AWBAT Plus 1/28/2010  More...
BG Medicine Announces Receipt of CE Mark for its Galectin-3 Blood Test 1/28/2010  More...
Notal Vision's ForeseeHome(TM) AMD Monitor Receives FDA Clearance 1/28/2010  More...
FDA Approves Medtronic, Inc. (MDT)'s (JOBS) First Percutaneous Heart Valve 1/28/2010  More...
Calibra Medical Inc. Receives 510(k) Clearance for the Finesse Insulin Patch-Pen, a Novel Way to Deliver Insulin 1/28/2010  More...
The PICC WAND from Access Scientific Receives FDA Clearance 1/27/2010  More...
Phadia AB Brings the First and Only Point of Care In Vitro Specific IgE Allergy Test with Final FDA Clearance of the ImmunoCAP(R) Rapid System 1/26/2010  More...
Medical Acoustics, LLC Receives FDA 510(k) Clearance of Therapeutic Lung Flute(R) 1/26/2010  More...
LTW Technologies Receives 5 FDA Clearances 1/25/2010  More...
FDA Approves for Permanent Treatment of Advanced Heart Failure Assist Device Pioneered by Texas Heart Institute at St. Luke's Episcopal Hospital 1/21/2010  More...
Neomend, Inc's ProGEL Lung Surgery Device Gets FDA Approval 1/20/2010  More...
Cyberonics Inc. (CYBX)'s VNS Therapy(TM) System Receives Regulatory Approval in Japan 1/19/2010  More...
St. Jude Medical (STJ) Announces Approval and Launch of Neurostimulation System in Japan 1/19/2010  More...
Corventis Announces FDA Clearance and US Launch of the NUVANT Mobile Cardiac Telemetry System 1/19/2010  More...
Invatec Receives 510(k) Clearance of REEF HP PTA Balloon Catheter 1/19/2010  More...
Abbott Laboratories (ABT) (JOBS) Receives European Regulatory Approval for New Ovarian Cancer Diagnostic Test 1/19/2010  More...
Elbit Imaging Ltd. (EMITF) Announces InSightec's First Non-Invasive Technology for Treatment of Uterine Fibroids Awarded MHLW Approval in Japan 1/14/2010  More...
Pathway Medical Technologies Inc. Receives FDA 510(k) Clearance for JETSTREAM G3 Atherectomy System 1/14/2010  More...
Michelson Diagnostics VivoSight(TM) OCT Scanner Receives FDA 510(k) Clearance 1/13/2010  More...
Diagnostic Hybrids, Inc. Announces FDA Clearance of D3(R) FastPointTM L-DFA(TM) RSV/MPV Identification Kit 1/12/2010  More...
Stereotaxis, Inc. (STXS) is Notified of the FDA Approval of an Additional Magnetic Irrigated Catheter 1/12/2010  More...
Crospon's EndoFLIP(R Device Receives FDA Approval; Secures Additional E2 million in Funding 1/12/2010  More...
Cytori Therapeutics, Inc. (CYTX) Gets FDA Nod for Body-Contouring Device; Stock Jumps 1/11/2010  More...
Seegene, Inc. Seeplex(R) Diarrhea-V ACE Detection Test Receives a Medical Device License From Health Canada 1/11/2010  More...
Cerner Corporation (CERN) Receives FDA Clearance for Medical Device Connectivity Solution 1/11/2010  More...
Abbott Laboratories (ABT)'s (JOBS) XIENCE V(R) Approved in Japan - Second Largest Drug Eluting Stent Market Worldwide 1/8/2010  More...
Zargis Medical Corp.: Zargis Cardioscan Cleared for Sale in Canada 1/8/2010  More...
Boston Scientific Corporation (BSX) (JOBS) Announces Japanese Approval for PROMUS(R) Everolimus-Eluting Coronary Stent System 1/8/2010  More...
Cepheid (CPHD) Receives FDA Clearance for First Rapid and Accurate Surveillance Test for vanA the Resistance Gene Most Associated with Hospital-Acquired VRE Infections 1/6/2010  More...
Volcano Corporation (JOBS) Announces Receipt of CE Mark for Its OCT Imaging System and Catheter 1/5/2010  More...
Lerner Medical Devices, Inc.'s Levia(R) for Personal Targeted Phototherapy(TM) Treatment of Psoriasis Receives FDA 510 (k) Clearance 1/5/2010  More...
Cepheid (CPHD) Gets FDA Emergency Approval for H1N1 Assay 1/4/2010  More...
Cardima, Inc. (CRDM)'s PATHFINDER(R) Diagnostic Catheters Receive Marketing Approval in Japan 1/4/2010  More...
ZOLL Medical Corporation (ZOLL) Receives FDA Clearance to Market E Series Defibrillators with Carbon Monoxide Monitoring 1/4/2010  More...
Bovie Medical Corporation (BVX) Announces FDA 510(k) Clearance to Market Resistick II Coated Electrodes 12/23/2009  More...
GI Dynamics Receives European CE Mark Approval for the EndoBarrier Gastrointestinal Liner System for the Treatment of Type 2 Diabetes and Obesity 12/22/2009  More...
AdvanDx, Inc. Receives FDA 510(k) Clearance for 90 Minutes PNA FISH(R) Protocol for Identifying Gram-Negative Bloodstream Pathogens 12/22/2009  More...
FDA Grants Emergency Use Authorization for TessArae(R) 2009 H1N1 Influenza A Virus Assay Based on the Affymetrix (Bedford, Massachusetts) (AFFX) (JOBS) GeneChip(R) Platform 12/21/2009  More...
Dilon Diagnostics Gamma-Guided Localization System Cleared by FDA 12/21/2009  More...
FDA Approves University of Pennsylvania-Developed Cancer Surgical Technique 12/21/2009  More...
3D Diagnostic Imaging plc Gets 510(k) Clearance for CarieScan PROtm 12/18/2009  More...
FDA Broadens Clearance for Agendia BV's MammaPrint(R) 12/17/2009  More...
OraSure Technologies, Inc. (OSUR) Receives CE Mark for OraQuick(R) Rapid HCV Antibody Test 12/15/2009  More...
EnzySurge Receives FDA Approval for SilverStream(TM) Innovative Wound Management Solution 12/15/2009  More...
Pathway Medical Technologies Inc. Receives CE Mark for the Jetstream G2 NXT 12/14/2009  More...
AdvanDx, Inc. Receives FDA 510(k) Clearance for 90 Minutes PNA FISH(R) Protocol for Identifying Staphylococcal Bloodstream Pathogens 12/11/2009  More...
FDA Clears Nexstim's Navigated Brain Stimulation For Non-Invasive Cortical Mapping Prior To Neurosurgery 12/10/2009  More...
Veran Medical Technologies Product Gets FDA OK 12/10/2009  More...
VentriPoint Diagnostics Announces European CE Mark Approval of Critical Cardiac Diagnostic System 12/10/2009  More...
TearLab Corporation (TEAR) Achieves Health Canada Approval 12/9/2009  More...
Activaero's AKITA(R) JET Receives FDA 510(K) Clearance 12/9/2009  More...
r4 Vascular Receives FDA 510(k) Clearance to Market the First Power-Injectable Apheresis Catheter 12/9/2009  More...
BIOLASE Technology, Inc. (BLTI) Announces FDA 510(k) Clearance of Its Waterlase MD(TM) Laser for Removing Calculus in Patients With Periodontal Disease 12/9/2009  More...
Veran Medical Technologies Receives FDA Clearance to Market Electromagnetic Navigated Bronchoscopy Product: The SPiN Drive(TM) System 12/8/2009  More...
ATS Medical, Inc. (ATSI) Announces CE Mark Approval for the ATS 3f Enable Bioprosthesis Enable is the First and Only Commercially Available Sutureless Surgical Tissue Valve 12/8/2009  More...
ATS Medical, Inc. (ATSI) Announces CE Mark Approval for the ATS 3f Enable Bioprosthesis 12/7/2009  More...
St. Jude Medical (STJ) Receives FDA Approval for Industry-First Five-Column Neurostimulation Lead to Manage Chronic Pain 12/4/2009  More...
Innomed Technologies, Inc: Nasal-Aire(R) II Petite Receives FDA 510(k) Clearance for Pediatric Use 12/3/2009  More...
Spectranetics Corporation (SPNC) Announces FDA Clearance of VisiSheath Dilator Sheath, New Lead Management Device 12/3/2009  More...
Ophthalmic Imaging Systems (OISI) Receives FDA Clearance to Market Revolutionary New Portable Digital Imaging Device 12/2/2009  More...
Avioq Receives FDA Approval for Anti-HIV-1 Microelisa System for Detection of Antibodies to HIV-1 in Serum, Plasma, Dried Blood Spots, or Oral Fluid Specimens Obtained with the OraSure(R) HIV-1 Oral Specimen Collection Device 12/2/2009  More...
FDA Approves Use of Roche (RHHBY) (JOBS) Test to Screen Source Plasma for HIV, Hepatitis B Virus and Hepatitis C Virus 12/2/2009  More...
Masimo Corporation Receives FDA Clearance for Masimo Rainbow SET(R) Acoustic Respiration Rate Monitoring 12/1/2009  More...
Ophthalmic Imaging Systems (OISI) Receives FDA Clearance to Market Revolutionary New Portable Digital Imaging Device 11/30/2009  More...
Prodesse, Inc.'s ProParaflu+(TM) Assay Cleared for US Marketing by FDA 11/25/2009  More...
BridgePoint Medical Receives European CE Mark for Stingray(R) and CrossBoss(TM) for Opening Completely Blocked Arteries 11/24/2009  More...
Intuitive Surgical, Inc. (ISRG) (JOBS) Gets Da Vinci Approval in Japan 11/24/2009  More...
DGIMED Ortho, Inc. Receives FDA Clearance on IM Nail System 11/23/2009  More...
Mesa Company, Guided Therapy Systems LLC Gets Approval to Market Ultrasound Treatment 11/23/2009  More...
Boston Scientific Corporation (BSX) (JOBS) Announces FDA Clearance and CE Mark for WallFlex(R) Fully Covered Esophageal Stent 11/20/2009  More...
Endologix Inc. Receives IDE Approval for Fully Percutaneous Approach to EVAR 11/19/2009  More...
Solta Medical, Inc. (SLTM) Announces New Fraxel Dual Laser System Receives CE Mark for European Market 11/19/2009  More...
Anika Therapeutics (ANIK) Receives European CE Mark Approval for "ELEVESS Light" 11/19/2009  More...
Doctors Research Group Receives FDA Clearance for U.S. Distribution of KRYPTONITE(TM) Bone Cement 11/18/2009  More...
SafeStitch Medical, Inc. Receives FDA Clearance to Market the AMID StaplerTM for Hernia Repairs 11/18/2009  More...
Quest Diagnostics Inc. (DGX) (JOBS) Gets European Approval for Swine Flu Test 11/18/2009  More...
EDDA Technology Completes CE Mark for IQQA(R)-Liver for Fast Quantitative Volumetry Assessment from Liver MDCT 11/13/2009  More...
Onset Medical Receives FDA Marketing Clearance for the SoloPath TransFemoral Endovascular Access Catheter 11/13/2009  More...
Kensey Nash Corporation (KNSY) Receives FDA 510(k) Clearance for Porcine Dermis Biologic Product Company's First ECM Approval 11/11/2009  More...
Vascular Solutions (VASC) Announces 510(k) Clearance and U.S. Launch of GuideLiner Catheter 11/10/2009  More...
Wright Medical Group, Inc. (WGMI) Receives FDA Approval to Market CONSERVE(R) Plus Total Hip Resurfacing System 11/9/2009  More...
China Medical Technologies, Inc. (CMED) Receives SFDA Approval for its Leukemia BCR/ABL Fusion Gene Detection FISH Probe 11/9/2009  More...
ARKRAY, Inc. Receives FDA Clearance for New GLUCOCARD(R) Vital(TM) Blood Glucose Monitoring System 11/6/2009  More...
PerkinElmer, Inc. (PKI) Secures FDA 510K Clearance for Newborn Screening Platform 11/4/2009  More...
AGA Medical Corporation (AGAM) Receives Product Approvals in China 11/4/2009  More...
BioMimetic Therapeutics, Inc. (BMTI) Receives First Orthopedic Marketing Approval for Augment(TM) Bone Graft 11/4/2009  More...
AGA Medical Corporation (AGAM) Receives Product Approvals in China 11/4/2009  More...
Cook Medical Release: First Device Designed to Preserve Blood Flow to Iliac Arteries During Aneurysm Repair Receives Approval from Health Canada 11/3/2009  More...
K2M Enters Japanese Spine Market with PMDA Clearance of MESA Spinal System 11/3/2009  More...
Edwards Lifesciences (EW) and DexCom (JOBS) Announce Receipt of CE Mark for Glucose Monitoring System 11/3/2009  More...
Kinetic Concepts, Inc. (KCI) Announces Final Approval to Enter Japan Market 11/2/2009  More...
FDA Clears SQI Diagnostics's Automated SQiDworks Diagnostics Platform and IgXPLEX Rheumatoid Arthritis Assay for Sale in the United States 11/2/2009  More...
Boston Scientific Corporation (BSX) (JOBS) Announces European Approval and Launch of Platinum Chromium PROMUS(R) Element(TM) Stent System 11/2/2009  More...
Stereotaxis, Inc. (STXS) Receives Notice of European Approval of an Additional Magnetic Irrigated Catheter 10/30/2009  More...
Diagnostic Hybrids, Inc. Announces FDA Clearance of D3(R) FastPointTM L-DFATM Influenza A/ Influenza B Virus Identification Kit 10/28/2009  More...
Lumenis Ltd. (LUME) Receives 510(k) Clearance for the PolyScope Disposable Flexible Endoscope 10/28/2009  More...
Ascent Healthcare Solutions Receives 510(K) Clearance to Reprocess Biosense Webster SoundStar 3D Diagnostic Ultrasound Catheter 10/28/2009  More...
FDA Clears Interlace Medical's MyoSureTM Hysteroscopic Tissue Removal System for The Treatment of Submucosal Fibroids 10/28/2009  More...
AdvanDx, Inc. Receives FDA 510(k) Clearance for 90 Minutes PNA FISH(R) Protocol for Identifying Enterococcal Bloodstream Pathogens 10/27/2009  More...
Lifebridge AG's Novel Cardio-Pulmonary Support Device From Germany Gains FDA Clearance 10/26/2009  More...
Synovis Life Technologies, Inc. (SYNO) Receives CE Mark Approval for the Use of Veritas(R) Collagen Matrix in Hernia Repair and Breast Reconstruction 10/23/2009  More...
Invatec Receives FDA Clearance for Mo.Ma(R) Ultra Proximal Cerebral Protection Device 10/23/2009  More...
American Medical Systems, Inc. (AMMD): AMS800 Artificial Urinary Sphincter Approved for Use in Japan 10/22/2009  More...
Collagen Matrix, Inc. Receives FDA 510(k) Clearance for New Collagen Dental Membrane Based on New Collagen Platform Technology 10/22/2009  More...
Response Biomedical (RBM.V) Obtains Special 510(k) U.S. FDA Clearance to Add Analytical Reactivity Information for the 2009 H1N1 Influenza A Virus to the RAMP(R) Influenza A/B Assay Package Insert 10/22/2009  More...
St. Jude Medical (STJ) Announces European CE Mark Approval and First Implant of Industry’s First Quadripolar Pacing System 10/20/2009  More...
FDA Approves New Abbott Laboratories (ABT) (JOBS) Test to Aid in the Diagnosis of Rheumatoid Arthritis 10/20/2009  More...
Solta Medical, Inc. (SLTM) Gets FDA Nod for Aesthetic Laser Device 10/16/2009  More...
Ortho Clinical Diagnostics Receives FDA Approval for First Anti-HIV 1+2 Test for Use on Random Access, Integrated Laboratory Testing System 10/15/2009  More...
SynCardia Systems, Inc.'s Companion Driver System Receives CE Mark to Power Total Artificial Heart in Europe 10/15/2009  More...
Biosense Webster Receives FDA Clearance for the CARTO(R) 3 System 10/15/2009  More...
CeloNova BioSciences: Minimally Invasive Device Approved to Treat Liver Cancer, Fibroids, Tumors, and Bleeding 10/14/2009  More...
Solos Endoscopy, Inc. (SLSE.PK)'s FDA Approved MammoView(TM) Product Line to Obtain CE Mark 10/14/2009  More...
Vascular Solutions (VASC) Gets FDA OK on Blood Clotting Device 10/14/2009  More...
Myconostica Ltd Attains CE Mark for MycAssay(TM) Aspergillus 10/14/2009  More...
Bovie Medical Corporation (BVX) Announces FDA 510(k) Clearance to Market Laparoscopic Device for Solid Organ Resection; Submits to FDA 510(k) Application for Resistick II Coated Electrodes 10/13/2009  More...
Nanosphere, Inc. Announces FDA 510(k) Clearance of the Verigene(R) SP and Respiratory Virus Nucleic Acid Test 10/13/2009  More...
HyperBranch Medical Technology, Inc. Receives CE Mark for its NuSeal 30 Hernia Mesh Fixation Sealant Product 10/13/2009  More...
Cardiopulmonary Corporation Receives Additional FDA 510(k) Class II Clearance Broadening Bernoulli(R) Enterprise's Indications for Use With Medical Devices 10/13/2009  More...
RSB Spine Announces FDA Clearance for the InterPlate(R) C-Ti as an Anterior Cervical Plate 10/13/2009  More...
ATS Medical, Inc. (ATSI) Announces Receipt of CE Mark for the New ATS CryoMaze 10-S Probe 10/13/2009  More...
BD Biosciences (BDX) (JOBS) Announces FDA 510(k) Clearance of BD Vacutainer(R) Rapid Serum Blood Collection Tube 10/7/2009  More...
HairDX, LLC Genetic Test for Hair Loss Now Available In Europe As A CE Marked In Vitro Diagnostic Medical Device 10/7/2009  More...
SonoSite Inc. (SONO) Announces FDA Clearance for Its New NanoMaxx Ultrasound Tool 10/6/2009  More...
Boston Scientific Corporation (BSX) (JOBS) Announces FDA Clearance and U.S. and European Availability of WallFlex(R) Biliary RX Covered Stents 10/6/2009  More...
AtriCure, Inc. (ATRC) Announces European Approval for its AtriClip(TM) System 10/6/2009  More...
Cerner Corporation (CERN) Receives FDA Clearance for Fetal Monitoring Solution 10/6/2009  More...
DexCom Receives CE Mark Approval for the SEVEN(R) PLUS Continuous Glucose Monitoring System 10/5/2009  More...
SonoSite Inc. (SONO) Announces FDA Clearance for Its New NanoMaxx Ultrasound Tool 10/5/2009  More...
ETEX Corporation Announces Additional FDA Clearance For EquivaBone(R), The First Hard Setting Osteoconductive and Osteoinductive Bone Graft Substitute 10/2/2009  More...
Solace Therapeutics, Inc. Announces CE Mark Approval 10/2/2009  More...
Given Imaging Ltd. (GIVN) Video Capsule Cleared for Young Children 10/2/2009  More...
Covidien (COV) Receives FDA Clearance for its Mallinckrodt Inc. TaperGuard Evac Endotracheal Tube 9/30/2009  More...
Life Spine Announces 510(k) Approval of SENTINEL(TM) OCT System 9/30/2009  More...
Flexible Stenting Solutions Inc. Receives Conditional IDE Approval for FlexStent(R) Femoropopliteal Self Expanding Stent System 9/29/2009  More...
Hologic, Inc. (HOLX) Receives CE Marking for the ThinPrep(R) Integrated Imager 9/29/2009  More...
Cepheid (CPHD)'s (JOBS) Thrombosis Test Gets FDA Nod 9/25/2009  More...
MedShape Solutions, Inc. Announces First FDA-Cleared Shape Memory PEEK Device; Closing of $10 Million Equity Offering 9/23/2009  More...
Maquet Cardiovascular LLC (JOBS) Receives FDA Clearance for MEGA(TM), the World's First 8Fr. 50cc Intra-Aortic Balloon Catheter Small Shaft Size on MEGA Benefits More Patients 9/23/2009  More...
U.S. FDA (JOBS) Approves Abbott Laboratories (ABT) HIV Screening Test 9/21/2009  More...
Osseon Therapeutics, Inc. Receives CE Mark 9/21/2009  More...
Cordis Corporation (JNJ)'s 2.25 MM CYPHER(R) Sirolimus-eluting Coronary Stent Approved by FDA 9/21/2009  More...
Invatec Announces Launch of REEF HP PTA Balloon Catheter in Europe 9/21/2009  More...
Flexible Stenting Solutions Inc. Receives 510(k) Clearance for FlexStent(R) Biliary Self Expanding Stent System 9/18/2009  More...
Michelson Diagnostics Awarded CE-Mark for Clinical Use of Its VivoSight OCT Scanner in Europe and for Non-Clinical Applications Worldwide 9/18/2009  More...
Michelson Diagnostics Awarded CE-Mark for Clinical Use of Its VivoSight OCT Scanner in Europe and for Non-Clinical Applications Worldwide 9/17/2009  More...
Ulthera Receives First-Ever FDA Clearance to Market Ultrasound Technology for Facial Aesthetic Improvement 9/17/2009  More...
SpectraScience, Inc. (SCIE.PK) Receives FDA Approval for Enhancements to WavSTAT(R) Optical Biopsy System 9/17/2009  More...
FDA Approves Quest Diagnostics Inc. (DGX) (JOBS), Vermillion Ovarian Cancer Test 9/16/2009  More...
Diagnostic Hybrids, Inc. Announces FDA Clearance of D3(R) FastPointTM L-DFATM Respiratory Virus Identification Kit 9/15/2009  More...
St. Jude Medical (STJ) Announces FDA Approval of EnSite Velocity Cardiac Mapping System 9/14/2009  More...
Abbott Laboratories (ABT) (JOBS) Announces Approval in China for Next-Generation XIENCE V(R) Drug Eluting Stent 9/14/2009  More...
Wright Medical Group, Inc. (WGMI) Announces FDA Clearance for PRO-STIM Osteoinductive Bone Graft Substitute 9/14/2009  More...
Corventis Announces CE Mark for AVIVO Mobile Patient Management System 9/14/2009  More...
St. Jude Medical (STJ) Receives CE Mark Approval for World's Smallest, Longest-Lasting Rechargeable Deep Brain Stimulator for Parkinson's Disease 9/9/2009  More...
Cochlear Limited Gets FDA Approval for Nucleus 5 9/8/2009  More...
Luminex Corporation (LMNX) Receives 510(K) Clearance for New Cystic Fibrosis Test 9/4/2009  More...
MEDICREA PASS(R) LP Iliac Fixation Receives FDA Clearance 9/3/2009  More...
Aerocrine: Canada Approves NIOX MINO for Asthma Monitoring 9/3/2009  More...
Hologic, Inc. (HOLX)'s Breast Cancer Treatment Gets FDA OK 9/3/2009  More...
Diagnostic Hybrids, Inc. Gets FDA Clearance for the Detection of Influenza A (H1N1)v Virus 9/1/2009  More...
Active Implants Corporation Announces CE Class III Medical Device Approval 9/1/2009  More...
Integrated Medical Systems, Inc. Receives CE Mark for World's First 'Suitcase' Intensive Care Unit 9/1/2009  More...
NeuroLogica Announces FDA 510(k) Clearance for inSPira HD: Portable High Resolution SPECT 9/1/2009  More...
Sanford Health: Spinal Implant Developed by Sanford Clinic Neurosurgeon Receives FDA 510(k) Market Clearance as a Lumbar Intervertebral Body Fusion Device 8/28/2009  More...
NeuroVasx Receives Canadian Approval for cPAX Aneurysm Treatment System 8/27/2009  More...
SuperSonic Imagine Receives FDA Approval for Aixplorer Ultrasound System 8/26/2009  More...
Aperio Technologies, Inc. Receives Second FDA Clearance for HER2 Image Analysis Application for Breast Cancer 8/25/2009  More...
ZOLL Medical Corporation (ZOLL) Receives FDA Approval to Market New LifeVest Model 8/25/2009  More...
Epocal Inc. Announces FDA Clearance of Glucose Test 8/24/2009  More...
vProtect Luminal Shield (TM) from Prescient Medical Receives CE Mark 8/24/2009  More...
Health Canada Approves Abbott Laboratories (ABT)'s (JOBS) XIENCE V(R) Drug Eluting Stent New Drug Eluting Stent Offers Outstanding Combination of Deliverability, Safety and Efficacy 8/24/2009  More...
EDAP TMS S.A. (EDAP) Receives U.S. FDA 510(k) Approval for Sonolith I-Sys 8/20/2009  More...
Oticon Medical Receives FDA Clearance to Market Innovative Bone Anchored Hearing System 8/20/2009  More...
Cerus Corporation (CERS)'s INTERCEPT Blood System for Platelets Receives Swiss Approval 8/19/2009  More...
SyntheMed, Inc. (SYMD.OB) Receives Russian Regulatory Approval for REPEL-CV(TM) 8/19/2009  More...
Nfocus Neuromedical, Inc. Announces US Clearance of Unique Guiding Catheter with Uni-body Internal Skeleton 8/18/2009  More...
IsoRay Medical, Inc. (ISRY) Announces FDA Clearance Supporting Enhanced Loading and Delivery Methods for the Treatment of Lung, Head and Neck, and Other Tumors 8/18/2009  More...
EndyMed Medical Receives FDA Clearance for Painless, Non-invasive Anti-Wrinkle Treatment System 8/18/2009  More...
IRadimed Corporation Announces 510K Clearance of the New Non-Magnetic MRidium(TM) MRI IV Pump with Integrated Masimo Corporation SET(R) SpO2 Monitoring 8/17/2009  More...
Reverse Medical Corporation Receives US FDA 510k Clearance for the ReCruitTM Microcatheter for Use Including Neuro Interventional Procedures 8/17/2009  More...
Angiotech Pharmaceuticals, Inc. (ANPI) Receives Approval for Quill(TM) SRS PDO, MONODERM(TM), Polypropylene and Nylon Product Lines for Sale in Brazil 8/13/2009  More...
Reverse Medical Corporation Receives CE Mark Clearance for the ReStore(TM) Microcatheter for Blood Flow Restoration in Acute Ischemic Stroke Patients 8/13/2009  More...
Nfocus Neuromedical, Inc. Obtains CE Approval for New Vascular Reconstruction Device 8/12/2009  More...
Cook Medical Announces CE Mark Approval and European Launch of the Zilver(R) PTX(R) Stent 8/12/2009  More...
CryoLife, Inc. (CRY) Receives FDA 510(k) Clearance for SynerGraft(R) Processed Human Cardiac Patch Material 8/12/2009  More...
Bovie Medical Corporation (BVX) Announces FDA 510(k) Clearance to Market Its J-Plasma Electrosurgical Generator and Handpiece 8/11/2009  More...