Sitemap > News > Diagnostics & Devices
- Abbott Announces Approval of First Fully-Automated Blood Screening Test for Hepatitis C Antibodies
- FDA Approves Demipulse And Demipulse Duo Generators
- St. Jude Medical Announces Japanese Approval of CRT-D Products to Treat Heart Failure Patients
- FDA Approves First Gene- Based Test To Detect The Spread Of Breast Cancer Into Lymph Nodes
- Medtronic Receives Approval for First Artificial Disc for the Neck in the United States
- Data Show Overlapping CYPHER® Sirolimus-eluting Coronary Stents Have Better Rates Of Key Clinical Indicators Than Overlapping Bare Metal Stents
- Ortho-Clinical Diagnostics Announces European Launch Of New Diagnostic Test for Chagas Disease
- Escalon Receives Clearance from FDA for Distribution of TRILOGY Analyzer
- Abbott Enrolls First Patient in World’s First Clinical Trial Designed to Study Drug Eluting Stent Treatment in Women
- Light Sciences Oncology Initiates Phase III Trial of Its Light Infusion Therapy (Litx) in Patients with Metastatic Colorectal Cancer
- Quest Diagnostics Announces New Testing Technique for Improved Diagnosis of Metabolic And Nutritional Disorders
- Boston Scientific Announces First Implant of TAXUS Element Platinum Chromium Stent
- bioMérieux launches the first automated detection test for Clostridium difficile A and B toxins
- Theregen Launches Second Phase I Study of Cardiovascular Heart Patch
- St. Jude Medical Announces First Clinical Trial Implant of Trifecta Stented Tissue Heart Valve
- St. Jude Medical Announces FDA Clearance of the Proxis Embolic Protection System
- Illumina Introduces the Infinium HumanHap550-Duo BeadChip
- CryoCor Receives FDA Approval for Right Atrial Flutter
- Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
- FDA Clears Radiation-Free Pulmonary Imaging System
- Thoratec Announces HeartMate II(R) PMA Will be Reviewed by FDA Advisory Panel
- Fastest Parathyroid Hormone test cleared for use during parathyroid surgeries
- IsoTis Receives FDA Clearance for Accell Family of Products
- Medtronic and Bayer Diabetes Care Announce Alliance to Provide Blood Glucose Meter to Medtronic Patients Outside the United States
- FDA Advisory Panel to Review Medtronic’s Endeavor Drug Eluting Stent in October
- St. Jude Medical Announces Japanese Approval of the Angio-Seal STS Plus Vascular Closure Device
- U.S FDA APPROVES GE HEALTHCARES NEWEST MOBILE MAMMOGRAPHY SYSTEM FOR IMPROVED ACCESS TO BREAST CARE
- Nuvelo Re-Initiates SONOMA-3 Trial of Alfimeprase in Patients With Catheter Occlusion
- Hemo-Stream™ Chronic Dialysis Catheter Receives FDA Clearance
- FDA Approves New Roche West Nile Virus Blood Screening Test Automated test helps ensure safety of blood supply by detecting virus earlier in infection cycle
- Abiomed Receives Conditional FDA Approval for Impella 2.5 Pivotal Study at up to 150 Hospitals
- Medtronic Announces European Launch of Wireless System Allowing Prompt Remote Monitoring and Management of Disease Progression in Patients with Heart Devices
- Quest Diagnostics Introduces ClariSure™ Test For Identifying Chromosome Abnormalities Associated With 85 Developmental Disorders In Children
- TAXUS WOMAN Study Reports Positive Clinical Outcomes for the TAXUS® Drug-eluting Stent in Women
- SIRS-Lab launches VYOO™, a novel DNA-based test for the detection of sepsis pathogens
- Penumbra, Inc. Completes Pivotal Stroke Trial of Intracranial Revascularization
- Illumina Introduces the Infinium(R) HumanLinkage-12 Genotyping BeadChip
- Arbios Systems Publishes Positive Results from Completed SEPET™ Feasibility Clinical Trials
- Diagnostic HYBRIDS Announces Release of D3® DFA Varicella-zoster Virus Identification Kit
- Four Analyses Of Three-Year Clinical Data Suggest CYPHER® Sirolimus-eluting Coronary Stent May Provide Alternative To Surgery For Patients With Multivessel Disease
- AtriCure Reports First Human Implant of the Cosgrove-Gillinov Left Atrial Appendage Occlusion System
- BioMosaics\' Glypican-3 Blood & Tissue Tests Receive CE Marking in Europe
- Neoprobe Provides Updated Phase 2 Clinical Data for Lymphoseek
- FDA Advisory Panel to Review Medtronic\'s Endeavor Drug Eluting Stent on October 10
- Rochester Medical Anti-Infection Foley Catheter Demonstrates Effectiveness in Randomized Trial
- Study Shows Medtronic Neurostimulation Therapy Improves Chronic Neuropathic Leg and Back Pain
- OncoMethylome Publishes Positive Clinical Trial Results for Urine-based Bladder Cancer Test
- Announcing commercial availability of SensiTrop™ HIV co-receptor tropism assay
- Calypte\'s Aware(R) HIV-1/2 OMT Oral Fluid Rapid Test Approved in USAID Waiver List
- St. Jude Medical Announces FDA Approval of Company\'s First Radiofrequency Wireless ICD and CRT-D Heart Failure Devices
- Nanosphere Announces First FDA Cleared Genetic Test for Warfarin
- First-in-man milestone reported for the Stentys bifurcated drug-eluting stent
- bioMérieux Launches VIDAS® NT-proBNP, an Aid for Diagnosis and Prognosis of Heart Failure
- FDA Approves SYMLIN Pen-Injector Devices Offering Convenience and Accuracy for SYMLIN Use
- Imaging Agent from Avid Radiopharmaceuticals to be Licensed by Bayer Schering Pharma for Early Detection of Alzheimer\'s Disease
- MedImmune Announces Phase 2 Safety Data for Anti-RSV Antibody and National RSV Surveillance Results
- Dade Behring Receives FDA Clearance for Rapid-Result Gram Positive Microbiology Tests
- Boston Scientific Announces European Approval of Next-Generation Implantable Defibrillator
- FDA advisory committee has unanimously recommended the company’s Endeavor® drug-eluting stent for conditional approval as a treatment for coronary artery disease
- deCODE Launches deCODE MI™ - A Test for a Major Genetic Risk Factor for Early-onset Heart Attack
- AMDL Submits Data to FDA for Clearance to Market Its DR-70® Diagnostic Test to Monitor Colorectal Cancer Patients
- Nanosphere Announces FDA Clearance of Second Molecular Diagnostics Assay
- Novadaq Launches Pinpoint: Company’s First Minimally Invasive Imaging System
- OMRIX Biopharmaceuticals Announces Positive Phase I Results with Fibrin Patch
- Aperio Receives FDA Approval for HER2 Image Analysis Application
- Tomophase To Exhibit First Cross-Sectional Images Of Human Bronchus Using Proprietary OCT System
- FDA Clears bioMérieux’s VIDAS® B·R·A·H·M·S PCT® Assay A First Indication for Sepsis Risk Assessment in the ICU
- Sorin Group announces the first U.S. clinical implant of OVATIO™ CRT
- Abbott Announces Positive One-Year Results from the World\'s First Clinical Trial of a Fully Bioabsorbable Drug Eluting Coronary Stent
- Abbott\'s XIENCE™ V Everolimus Eluting Coronary Stent Shows Continued Superiority to TAXUS Stent in Reducing Major Adverse Cardiac Events in SPIRIT III Clinical Trial
- Positive Five-Year Safety Data for TAXUS® Stent Reported in Boston Scientific Trial
- Boston Scientific\'s Next-Generation Stent Shows Improved Clinical Outcomes in Complex Lesions
- Boston Scientific PROMUS™ and TAXUS® Stents Continue Strong Performance in Safety and Efficacy Measures
- ARRIVE Registry Analysis Demonstrates Continued Safety and Efficacy of TAXUS® Stent in Complex Real-World Patients
- Elixir Medical Announces Positive Clinical Results for the Company\'s First Drug Eluting Coronary Stent
- New Long-Term Data Suggest Clinical Differences In Safety And Efficacy Between CYPHER® Sirolimus-eluting Coronary Stent And Taxus Stent
- New Study Shows Excellent Outcomes For CYPHER® Sirolimus-eluting Coronary Stent In Treatment Of Completely Blocked Coronary Arteries
- XTENT Announces Positive Two-Year CUSTOM I and One-Year CUSTOM II Trial Data for Novel Drug-Eluting Stent System
- Boston Scientific Carotid Artery Stenting Trials Produce Positive Three-Year Results
- Edwards\' Resilient Trial Demonstrates Statistically Superior Results for Treating Peripheral Arterial Disease in the Leg
- Medtronic Trials Confirm Ability of Interceptor® Coronary Filter System and Export® Aspiration Catheter to Reduce Major Cardiac Events
- DIAMICS RECEIVES EUROPEAN CE MARK APPROVAL FOR ITS PAP-MAP™ SYSTEM FOR CERVICAL CANCER SCREENING
- First U.S. Patients Receive Transoma Medical\'s Sleuth™ Wireless Remote Implantable ECG Monitoring System
- Neoprobe Completes FDA Meeting Regarding Lymphoseek
- Rosetta Genomics completes prevalidation phase for first diagnostic product
- Two Point of Care Tests From Quest Diagnostics Receive FDA 510(k) Clearance
- Cytori Receives European Approval for 2nd Generation Celution™ Stem & Regenerative Cell Processing System
- Addition of INTEGRILIN(R) (Eptifibatide) to Bivalirudin Plus Standard of Care Inhibits Platelet Aggregation in Patients Undergoing Elective Coronary Stenting
- Toshiba Introduces faCTor64 Study to Improve Early Diagnosis and Treatment of Coronary Artery Disease in Asymptomatic Diabetics
- St. Jude Medical Announces One-Year Results from MASCOT Trial
- St. Jude Medical Announces Results from RethinQ Clinical Trial
- Invitrogen and Biosynth Partner to Launch Rapid Detection Products for MRSA Contamination in Hospitals
- Baxter Receives 510(k) Clearance from FDA for V-Link with VitalShield, New Antimicrobial Intravascular Technology
- AngioDynamics Highlights Study Showing Significant 5-Year Survival After Ablation of Colorectal Liver Metastases
- Commencement of clinical trials for warfarin
- Panacea Pharmaceuticals Announces the Availability of BC Detectsm, a Serum-Based Diagnostic Test for Breast Cancer
- BREAKTHROUGH IN HIGH SENSITIVITY TB AND MALARIA DIAGNOSTICS
- Medtronic Receives FDA Marketing Clearance for Complete SE Biliary Stent System
- EXACT Sciences Announces Results of Multi-Center Study of Version 2 Stool DNA Technology for Colorectal Cancer Screening
- BiPar Genomic Biomarker Data Demonstrate Overexpression of PARP1 Gene in Multiple Cancer Types
- EarlySense receives FDA clearance for its contact-free patient clinical status monitor
- Delcath Resumes Enrollment in Phase III and Phase II Trials
- FDA Clears Advanced Test for Monitoring Metastatic Colorectal Cancer
- CellSearch Circulating Tumor Cell Kit Receives FDA Clearance for Monitoring Patients with Metastatic Colorectal Cancer
- St. Jude Medical Announces FDA Approval of Epic Stented Tissue Valve with Anti-Calcification Technology
- Abbott to Present Comprehensive Safety and Efficacy Data on XIENCE™ V Drug Eluting Stent to FDA Advisory Committee on November 29
- FDA Advisory Committee Recommends Approval of Abbott’s XIENCE™ V Drug Eluting Stent System
- Thoratec Announces Unanimous FDA Advisory Panel Recommendation for Approval of HeartMate II(R) for Bridge-to-Transplantation
- Medtronic Files PMA Application for FDA Approval of Talent Abdominal Stent Graft System
- Announced the Filing for FDA Clearance of the CellSearch™ Circulating Tumor Cell Kit for Monitoring Patients with Metastatic Androgen-Independent Prostate Cancer
- THEREGEN COMPLETES ENROLLMENT OF ANGINERA PHASE I SAFETY TRIAL; PREPARES FOR PHASE II SUBMISSION
- Cyberkinetics Receives FDA Response Letter on Andara(TM) OFS(TM) System for Acute Spinal Cord Injury
- Medtronic Starts First Human Study of Endurant™ Stent Graft System for Treatment of Abdominal Aortic Aneurysm
- Clinical Data Initiates Long-Term Safety Study for Vilazodone
- BioSphere Medical Receives CE Mark Approval for Transarterial Chemoembolization Using HepaSphere(TM) Microspheres
- Introgen Plans to Expand Biomarker Database in Phase 3 Trials and File BLA and MAA for ADVEXIN in Advanced Head and Neck Cancer in First Half of 2008
- Luminex Receives U.S. Food and Drug Administration Clearance for xTAG Respiratory Viral Panel
- ImaRx Provides Update on Tucson Phase I/II Clinical Trial In Acute Ischemic Stroke.
- First Molecular Test to Simultaneously Identify Staphylococcus aureus and Methicillin-Resistant Staphylococcus aureus from Positive Blood Cultures
- VGX Pharmaceuticals announces successful completion of the first human study to assess the tolerability of CELLECTRA™ electroporator
- CytoCore Launches SoftPAP™ Cervical Cell Collector in Europe
- BSD Medical Receives Letter from FDA on BSD-2000
- Dako receives FDA approval of TOP2A FISH pharmDx
- Fully Automated, Irrigated Tip Radiofrequency Ablation System with Remote Navigation Receives FDA Approval
- PreMD Announces FDA Decision on POC Skin Cholesterol Test
- St. Jude Medical Announces FDA and European CE Mark Approvals of Durata Defibrillation Lead
- Fermiscan begins clinical trial in Singapore for breast cancer detection
- Biosensors receives CE Mark approval for its BioMatrix drug-eluting stent.
- CeloNova BioSciences Introduces a New Class of Coronary
- Abbott Announces Approval of First Fully Automated Blood Screening Test for HTLV-I/HTLV-II
- Boston Scientific Announces CE Mark Approval for New Devices to Treat Heart Failure and Sudden Cardiac Death
- St. Jude Medical Announces FDA and European CE Mark Approval of the QuickFlex Family of Leads
- Northstar Neuroscience Announces Updated Timeline for EVEREST Pivotal Trial Data Analysis and Planned PMA Submission
- Abiomed Receives HDE Supplement Approval for AbioCor Artificial Heart
- Neuronetrix and the University of Kentucky Test New Device to Screen for Alzheimer’s Disease
- Edwards Lifesciences Receives FDA Approval to Add Transapical Delivery System to U.S. Clinical Trial of Transcatheter Heart Valve
- Medtronic Announces FDA Approval of CGMS iPro Continuous Glucose Recorder
- AngioScore Obtains Japanese Approval for AngioSculpt Scoring Balloon Catheter
- Calypte Unveils Aware Messenger(TM), an Oral Specimen Collection Device Developed Especially for High-Throughput Testing Laboratories
- Medtronic Receives FDA Approval for Endeavor® Zotarolimus-Eluting Coronary Stent System
- EPIX Pharmaceuticals Reaches Agreement with FDA on Protocol, Initiates Re-Read of Vasovist Phase 3 Images
- St. Jude Medical Announces European CE Mark Approval of Integrated Irrigation Pump and Cardiac Ablation Generator
- Data Presented on Monogram HIV Tropism Tests at Retrovirus Conference sets New Standards of Assay Sensitivity
- Medtronic Receives U.S. FDA Approval for New Neurostimulator with Innovative Patient Programmer
- CryoLife Receives FDA 510(k) Clearance for SynerGraft(R) Processed Human Pulmonary Heart Valves
- deCODE launches a DNA-based test for assessing risk of prostate cancer on the back of the discovery of new prostate cancer genes
- AGA Medical Corporation Receives European CE Mark Approval for the AMPLATZER® Duct Occluder II
- St. Jude Medical Receives FDA and CE Mark Approvals of Extended 10-Year Battery Life Claim for Rechargeable Neurostimulator
- Gen-Probe Submits U.S. Regulatory Application for Additional Approval of PROCLEIX(R) ULTRIO(R) Blood Screening Assay
- diaDexus Receives FDA Clearance For Automated Blood Test That Identifies Stroke and Heart Attack Risk
- ATS Medical Announces Initial Clinical Results of Stand-Alone Atrial Fibrillation Procedures Using ATS CryoMaze Product Line
- Arbios Receives Conditional Approval from the FDA to Initiate Pivotal Clinical Trial for SEPET
- Boston Scientific Announces Three FDA Product Approvals for Its Cardiac Rhythm Management Business
- CellSearch™ Now Indicated For Metastatic Prostate Cancer
- FDA Grants Market Clearance to Aerocrine Inc.’s NIOX MINO: a New Hand-Held Device to Measure Airway Inflammation in Asthma
- Vasogen Provides Update on ACCLAIM II Program
- Panacos Announces Discovery of Bevirimat Patient Response Predictors
- St. Jude Medical Announces Japanese Approval and Launch of Tailor Flexible Ring and Band for Heart Valve Repair
- Third Wave\'s HPV Clinical Trial Achieves Primary Clinical Endpoints
- Mobidiag Releases First Microarray Based Rapid Test for Herpesvirus Identification
- Medtronic Introduces Improvement to Minimally Invasive Treatment of Aortic Aneurysms in Europe
- Innocoll Announces Dosing of First Patient in a Second US Phase 2 Clinical Trial to Investigate CollaRx® BUPIVACAINE SURGICAL IMPLANT for the Management of Post-operative Pain
- FDA Clears bioMérieux’s VIDAS® NT-proBNP
- FDA Approves Abbott\'s FreeStyle Navigator® Continuous Glucose Monitoring System
- Phosphagenics today announced that it has received ethics approval to commence treating patients with Type 1 diabetes in a Phase 2 clinical trial using its patented transdermal insulin delivery system, TPM/Insulin
- QuantRx® Announces Commencement of Phase I Clinical Trial by FluoroPharma for BFPET™, a Myocardial Perfusion Imaging (MPI) Tracer for Positron Emission Tomography (PET)
- VIA Pharmaceuticals Completes Enrollment In Phase 2 Carotid Endarterectomy (CEA) Trial
- Vermillion Announces Positive Results From Clinical Trial of Ovarian Tumor Triage Test; Study Meets Primary Endpoints
- Zogenix Announces sumatriptan DosePro NDA Accepted for Filing by FDA
- Repligen Initiates Phase 3 Clinical Trial of RG1068 for Pancreatic MRI Imaging
- Medtronic’s New Endeavor® Zotarolimus-Eluting Stent Approved for Patients with Coronary Artery Disease in Canada
- FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries
- OMRIX Biopharmaceuticals Initiates Phase II Clinical Trial for Fibrin Patch Product Candidate
- TAXUS® Stent Demonstrates Similar Outcomes in Diabetic Patients Compared to Non-diabetics in Pooled Analysis of TAXUS IV and V Trials
- Spirit II Results Support Strength of Boston Scientific\'s Two Drug-Eluting Stent Platforms
- Study Finds Taxus® Drug-Eluting Stent Beneficial in Treatment of Large Vessels
- Real-World Data from ARRIVE Registries Show Favorable Outcomes for TAXUS® Express™ Stent
- 12-Month Data from Endeavor IV Show Strong Clinical Efficacy of Medtronic’s Drug-Eluting Stent Across All Patient Groups
- Gen-Probe Begins U.S. Clinical Study of Molecular Test for Human Papillomavirus, Which Causes Cervical Cancer
- Thermo Fisher Scientific Receives FDA Clearance for MRSA Test Medium
- OrbusNeich Receives CE Mark Approval for Sapphire 1.25mm PTCA Dilatation Catheter
- DURECT Provides Update on CHRONOGESIC(R) Research Program
- B·R·A·H·M·S Receives Final FDA Clearance To Market Procalcitonin (PCT)
- St. Jude Medical Receives FDA and CE Mark Approvals for the World\'s Smallest, Longest-Lasting Rechargeable Neurostimulator to Treat Chronic Pain
- Boston Scientific Announces Japanese Approval of Heart Failure Lead
- Repligen Receives FDA Fast Track Designation for RG1068 for Pancreatic Imaging
- Calypte\'s Aware(TM) HIV-1/2 OMT Approved as China\'s Only Rapid Oral HIV Test
- Angiotech\'s Novel 5-FU Central Venous Catheter Receives FDA 510(k) Clearance
- Thoratec Announces FDA Approval of HeartMate II(R) for Bridge-To-Transplantation
- Third Wave Completes FDA Submissions for Its Two HPV Products
- Acusphere Submits New Drug Application for FDA Approval of Imagify
- Beckman Coulter Acquires Rights to Hepatitis C Virus
- AngioScore Receives FDA Clearance to Market AngioSculpt PTA Scoring Balloon Catheter for Additional Peripheral Indications
- HER1 and HER3 VeraTag Assays are Now Available for Use in Development and Clinical Evaluation of Cancer Therapeutics
- Vascular Insights Receives FDA Clearance for Infusion Catheter
- Boston Scientific Announces FDA Approval of New Family of Advanced Pacemakers
- Boston Scientific Announces European Approval and Market Launch of New Family of Advanced Pacemakers
- OncoVista Innovative Therapies, Inc. Announces Submission of Request for pre-IDE Meeting
- XIENCE™ V Drug Eluting Stent from Abbott Outperforms Market-Leading Stent in Reducing Major Adverse Cardiac Events at Two Years
- St. Jude Medical Announces Start of Landmark DETERMINE ICD Study
- TAXUS® Express® Stent Shows Similarly Low Re-Intervention Rates in Patients with Diabetes Compared to Non-Diabetics in ARRIVE Registry Program
- Thrombus Aspiration Before Stenting Benefits Patients Suffering Myocardial Infarction, Study Shows
- Medtronic Announces FDA Approval of New Vision 3D Wireless Implantable Cardiac Devices
- St. Jude Medical Announces Launch of New Circular Mapping Catheter
- St. Jude Medical Announces FDA and European CE Mark Approvals of the IsoFlex Optim Pacing Lead
- St. Jude Medical Announces Start of Landmark DETERMINE ICD Study
- SPIRIT III Results Reaffirm Strong Performance of Boston Scientific PROMUS™ and TAXUS® Express® Stents
- Boston Scientific Announces FDA Approval for New Devices to Treat Heart Failure and Sudden Cardiac Death
- SORIN GROUP ANNOUNCES FDA APPROVAL OF THE WORLD’S SMALLEST CARDIAC RESYNCHRONIZATION IMPLANTABLE CARDIOVERTER DEFIBRILLATOR: OVATIO CRT
