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The Healthcare Sales & Marketing Network celebrates 28 years serving the medical sales & marketing community.Connecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product LinesConnecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product Lines

Healthcare News Roundup: FDA

 HSMN NewsFeed - 16 Jun 2010
BioElectronics Advances in Its FDA Clearances
Devices FDA
 HSMN NewsFeed - 16 Jun 2010
KCI Receives FDA Clearance for Prevena Incision Management System
Devices Wound Care FDA
 HSMN NewsFeed - 15 Jun 2010
Epocal Announces FDA Clearance of Lactate Test
Diagnostics FDA
 HSMN NewsFeed - 14 Jun 2010
HeartWare Receives Conditional FDA Approval to Commence Pivotal Destination Therapy Clinical Trial in the U.S.
Devices Cardiology FDA
 HSMN NewsFeed - 14 Jun 2010
AtriCure's AtriClip System Receives FDA 510(k) Clearance
Devices Cardiology FDA
 HSMN NewsFeed - 11 Jun 2010
Cook Medical Files Pre-Market Approval Application for FDA Approval of Zilver(R) PTX(R) Drug-Eluting Stent Platform
Devices Interventional
 HSMN NewsFeed - 11 Jun 2010
FDA Lifts Full Clinical Hold on Repros' Proellex(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 Jun 2010
Human Genome Sciences Announces Submission of Biologics License Application to FDA for BENLYSTA(R) (belimumab)
Biopharmaceuticals
 HSMN NewsFeed - 8 Jun 2010
CryoLife Receives FDA 510(k) Clearance for CryoValve(R) SG Pulmonary Heart Valve Shelf-life Extension
Devices Cardiology FDA
 HSMN NewsFeed - 8 Jun 2010
Salix Pharmaceuticals Announces NDA Submission For XIFAXAN550 For Treatment of Non-Constipation Irritable Bowel Syndrome
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 8 Jun 2010
Cepheid Receives FDA Clearance for Xpert SA Nasal Complete, the First Molecular Test for Simultaneous Detection and Differentiation of S. aureus & MRSA Colonization
Diagnostics FDA
 HSMN NewsFeed - 7 Jun 2010
Gore Receives FDA Approval for 45 mm GORE(R) TAG(R) Thoracic Endoprosthesis
Devices Interventional FDA
 HSMN NewsFeed - 4 Jun 2010
Mylan Receives Approval for Generic Version of Neurontin(R) Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 4 Jun 2010
FDA Approves New Roche Dual-PCR Target HIV-1 Test
Diagnostics FDA HIV/AIDS
 HSMN NewsFeed - 3 Jun 2010
Abbott Receives FDA Clearance for New Ovarian Cancer Test
Diagnostics Oncology FDA
 HSMN NewsFeed - 3 Jun 2010
Taro Receives FDA Approval for Granisetron Hydrochloride Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 2 Jun 2010
Teva Announces Launch of Generic Differin(R)
Biopharmaceuticals Generics Dermatology FDA
 HSMN NewsFeed - 2 Jun 2010
MAQUET Cardiovascular Receives 510(k) Marketing Clearance for QUADROX-iD Pediatric Diffusion Membrane Oxygenator
Devices Cardiology Surgery FDA
 HSMN NewsFeed - 1 Jun 2010
FDA Approves Amgen's Prolia(TM) (Denosumab) for Treatment of Postmenopausal Women With Osteoporosis at High Risk for Fracture
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Jun 2010
CoaguSense Receives FDA Clearance for the CoaguSense Blood Coagulation Testing System for Patient Home Use
Devices Diagnostics Monitoring FDA
 HSMN NewsFeed - 1 Jun 2010
Cysview(TM) (Hexaminolevulinate HCL) Approved by the FDA for Cystoscopic Detection of Papillary Bladder Cancer
Diagnostics Oncology FDA
 HSMN NewsFeed - 1 Jun 2010
Lorus Therapeutics Files Investigational New Drug Application With FDA for Anticancer Drug LOR-253
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 1 Jun 2010
Orexigen(R) Therapeutics Announces FDA Acceptance of Contrave(R) New Drug Application for the Treatment of Obesity
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 May 2010
KCI Announces FDA Clearance of V.A.C.(R) Therapy for Venous Insufficiency Ulcers
Devices Wound Care
 HSMN NewsFeed - 28 May 2010
Roche Diagnostics Receives FDA Approval for Qualitative Anti-HCV Immunoassay Test on Three Analyzer Platforms
Diagnostics FDA
 HSMN NewsFeed - 27 May 2010
Repligen Announces FDA and EMA Approval of Re-analysis of Images from Phase 3 Trial of RG1068 for Pancreatic Imaging
Biopharmaceuticals Radiology
 HSMN NewsFeed - 27 May 2010
Covidien Expands V-Loc Family of Absorbable Wound Closure Devices for Knotless Tissue Repair
Devices Surgery FDA Wound Care
 HSMN NewsFeed - 26 May 2010
KENSEY NASH Receives FDA 510(k) Clearance for ECM Product, Meso BioMatrix Surgical Mesh
Devices Surgery FDA
 HSMN NewsFeed - 25 May 2010
KFx Medical Corporation Announced Today It Has Received FDA 510k Clearance for Product(s) Used in a Wide Variety of Arthroscopic Tenodesis Knee Procedures Such as: ACL, PCL, and Patellofemoral Ligament (MPFL) Reconstruction
Devices Orthopaedic FDA
 HSMN NewsFeed - 25 May 2010
Genzyme Receives FDA Approval for Lumizyme for Pompe Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 May 2010
Boston Scientific Announces CE Mark and FDA Approval of NC Quantum Apex Balloon Catheter
Devices FDA Interventional Cardiology Regulatory
 HSMN NewsFeed - 24 May 2010
Somanetics Receives 510(k) Clearance From the FDA to Expand Features on Its Vital Sync Monitor
Devices Monitoring FDA
 HSMN NewsFeed - 24 May 2010
Repligen Receives Orphan Drug Designation from the FDA for RG2833 for Friedreich's Ataxia
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 21 May 2010
SurgiQuest, Inc. Receives FDA Clearance to Market the World's First Elastomeric Single Incision Laparoscopy Kit
Devices Surgery FDA
 HSMN NewsFeed - 19 May 2010
Volcano Announces 510(k) Clearance, CE Mark Approval, and First Clinical Use for the PrimeWire PRESTIGE(TM) Pressure Guide Wire
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 19 May 2010
Abbott Receives FDA Approval for First Fully Automated Blood Test for 'Kissing Bug' Disease
Diagnostics FDA
 HSMN NewsFeed - 18 May 2010
FDA Approves Boston Scientific's Genesys HTA System
Devices FDA
 HSMN NewsFeed - 18 May 2010
LensAR Laser System(TM) Receives FDA Clearance for Use in Cataract Surgery
Devices Ophthalmology FDA
 HSMN NewsFeed - 18 May 2010
ev3 Inc. Files PMA Application for FDA Approval of Pipeline Embolization Device
Devices Interventional Neurology FDA
 HSMN NewsFeed - 17 May 2010
ROXRO Announces FDA Approval of SPRIX(TM)
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 14 May 2010
Teva Announces Tentative Approval of Generic Sensipar(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 14 May 2010
Impax Laboratories Receives Tentative FDA Approval for Generic Opana(R) ER 5, 7.5, 10, 15, 20, 30 and 40 mg Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 13 May 2010
St. Jude Medical Advances Integration of Electrophysiology Lab Equipment with Launch of EnSite Derexi Module
Devices Cardiology FDA
 HSMN NewsFeed - 13 May 2010
Boston Scientific Announces FDA Clearance of New Heart Failure Lead Delivery System
Devices Cardiology FDA
 HSMN NewsFeed - 13 May 2010
NicOx provides update on FDA Advisory Committee Meeting for naproxcinod
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 May 2010
St. Jude Medical Announces FDA Approval of Unify CRT-D and Fortify ICD
Devices Cardiology FDA
 HSMN NewsFeed - 12 May 2010
BIOTRONIK Evia Advanced Pacemaker Receives FDA Approval
Devices Cardiology FDA
 HSMN NewsFeed - 12 May 2010
Sagent Pharmaceuticals Announces FDA Approval of Bacitracin for Injection, USP
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 May 2010
Hansen Medical Announces FDA Conditional IDE Approval for Evaluating Sensei X Robotic Catheter System for Treatment of Atrial Fibrillation
Devices Cardiology FDA
 HSMN NewsFeed - 12 May 2010
Aeterna Zentaris: FDA Approves Investigational New Drug (IND) Application for Doxorubicin Targeted Conjugate Compound, AEZS-108, in Bladder Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 12 May 2010
Terumo To Simultaneously Evaluate Misago Self-Expanding Stent System in the United States and Japan
Devices Interventional FDA
 HSMN NewsFeed - 11 May 2010
SonarMed Receives FDA Clearance for Respiratory Product
Devices Monitoring FDA
 HSMN NewsFeed - 11 May 2010
FDA Approves Cefepime for Use In B. Braun's DUPLEX(R) System
Devices Drug Delivery FDA
 HSMN NewsFeed - 11 May 2010
Boston Scientific Announces FDA Approval for LATITUDE(R) Patient Management System Software Upgrade
Devices Cardiology Monitoring FDA
 HSMN NewsFeed - 10 May 2010
Miraculins Signs Letter of Intent to License FDA Cleared PreVu Skin Cholesterol Test
Diagnostics Cardiology Licensing
 HSMN NewsFeed - 10 May 2010
Cipher achieves major milestone with FDA approval for CIP-TRAMADOL ER
Biopharmaceuticals FDA
 HSMN NewsFeed - 7 May 2010
U.S. FDA Approves Natazia(TM), a New Oral Contraceptive for the Prevention of Pregnancy
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 May 2010
DGIMED ORTHO Receives FDA Clearance on Titanium IM Nail System
Devices Orthopaedic FDA
 HSMN NewsFeed - 4 May 2010
Mylan Receives Approval for Generic Version of Zyban(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 3 May 2010
FDA Approved VIMOVO(TM) for Arthritis Patients at Risk of Developing NSAID-Associated Gastric Ulcers
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 3 May 2010
Abbott Receives FDA Approval for CREON(R) to Include Dosing Information for Patients With Chronic Pancreatitis and Pancreatectomy
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Apr 2010
Repros Receives Guidance From FDA Regarding Clinical Hold Status of Proellex(R)
Biopharmaceuticals
 HSMN NewsFeed - 29 Apr 2010
Bavarian Nordic Receives FDA Fast Track Designation for PROSTVAC(TM)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 28 Apr 2010
Abbott Receives FDA Approval for Once-Daily Dosing of Kaletra(R) (lopinavir / ritonavir) for Treatment-Experienced Patients
Biopharmaceuticals HIV/AIDS FDA
 HSMN NewsFeed - 28 Apr 2010
Fenwal Receives FDA Clearance for Amicus(R) Separator With Wireless Connectivity
Devices FDA
 HSMN NewsFeed - 28 Apr 2010
Teva Announces Launch of Generic Flomax(R)
Biopharmaceuticals Generics Urology FDA
 HSMN NewsFeed - 28 Apr 2010
Asthmatx Receives FDA Approval for the Alair(R) Bronchial Thermoplasty System
Devices FDA
 HSMN NewsFeed - 28 Apr 2010
Mylan Receives Approval for Generic Version of Flomax(R)
Biopharmaceuticals Generics Urology FDA
 HSMN NewsFeed - 27 Apr 2010
Boston Scientific Expresses Willingness To Discuss Modification of Guidant Plea Agreement
Devices Cardiology Litigation FDA
 HSMN NewsFeed - 27 Apr 2010
FDA Provides Clearance of TYRX Antibacterial Patch for Soft Tissue Repair
Devices Surgery FDA
 HSMN NewsFeed - 26 Apr 2010
KCI Statement on FDA Medical Device Home Use Initiative
Devices Wound Care FDA
 HSMN NewsFeed - 26 Apr 2010
Medtronic Launches Award-Winning Neuro Oncology Surgical Imaging System in the United States
Devices Neurosurgery Oncology FDA
 HSMN NewsFeed - 26 Apr 2010
Digirad Receives FDA Clearance for Ergo Large Field-of-View, Solid-State, General Imaging Nuclear Medicine Camera
Devices Radiology FDA
 HSMN NewsFeed - 26 Apr 2010
Osmetech plc Receives 510(k) Clearance for the eSensor(R) Thrombophilia Risk Test
Diagnostics FDA
 HSMN NewsFeed - 23 Apr 2010
Merz Aesthetics Announces FDA Approval of Asclera(TM) (Polidocanol) Injection, First Sclerosant to Treat Small Varicose Veins in 60 Years
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Apr 2010
UCB Receives Complete Response Letter from U.S. FDA Regarding Neupro(R) (Rotigotine)
Biopharmaceuticals Drug Delivery Neurology FDA
 HSMN NewsFeed - 23 Apr 2010
NDS Surgical Imaging Receives FDA Clearance for ZeroWire Wireless HD Video Technology Solution
Devices Surgery FDA
 HSMN NewsFeed - 23 Apr 2010
Genentech Submits Supplemental Application to FDA for Herceptin in Advanced HER2-Positive Stomach Cancer
Biopharmaceuticals Oncology
 HSMN NewsFeed - 22 Apr 2010
Flexuspine Receives FDA Conditional Approval to Begin a Feasibility Study of Its FSU (Functional Spinal Unit) Total Spine Arthroplasty System in the United States
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 22 Apr 2010
Novartis Receives US FDA Approval for Zortress(R) (everolimus) to Prevent Organ Rejection in Adult Kidney Transplant Recipients
Biopharmaceuticals FDA
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