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Healthcare News Roundup: FDA

 HSMN NewsFeed - 3 Dec 2008
Medtronic Announces FDA Approval and Market Availability of Sprint Quattro Secure(R) S Single Coil Defibrillation Lead
Devices Cardiology FDA
 HSMN NewsFeed - 3 Dec 2008
AVI BioPharma Files IND for Clinical Trial of Marburg Virus Treatment
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Dec 2008
Starch Medical Launches New, Bioinert Surgical Hemostats
Devices Surgery FDA
 HSMN NewsFeed - 2 Dec 2008
MAKO Surgical Corp. Receives FDA Clearance to Market Both Its Version 2.0 Tactile Guidance System(tm) and Its Bicompartmental Knee Resurfacing Implant System
Devices FDA Orthopaedic
 HSMN NewsFeed - 1 Dec 2008
Innovative IV Catheter Receives FDA Clearance and Secures Funding from Washington Area Venture Capital Firm
Devices Venture Capital
 HSMN NewsFeed - 1 Dec 2008
FDA Accepts Cell Therapeutics' Zevalin sBLA and Grants Priority Review
Biopharmaceuticals Oncology
 HSMN NewsFeed - 26 Nov 2008
PLC Systems Receives Full FDA Approval for Pivotal Study of RenalGuard(TM) in The U.S.
Devices Interventional FDA
 HSMN NewsFeed - 26 Nov 2008
FDA Issues Complete Response Letter for Ceftobiprole for Treatment of Complicated Skin Infections
Biopharmaceuticals
 HSMN NewsFeed - 24 Nov 2008
Biovitrum's and Syntonix's Novel Factor IXFc for Hemophilia B has Received Orphan Drug Designation From the FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Nov 2008
Cook Medical Receives Conditional Approval from FDA to Begin Clinical Trial for Zenith® Low Profile AAA Endovascular Graft
Devices Interventional
 HSMN NewsFeed - 19 Nov 2008
Naviscan Receives 510(k) Clearance for Stereo Navigator(TM) - the First Commercially Available Breast PET-Guided Biopsy Feature
Devices Radiology Oncology FDA
 HSMN NewsFeed - 19 Nov 2008
FDA Clears The DPL (Deep Penetrating Light) Therapy System For Over-the-Counter Home Use
Devices FDA
 HSMN NewsFeed - 18 Nov 2008
Delcath Systems Granted Orphan-Drug Designations for Cutaneous and Ocular Melanoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 18 Nov 2008
Medicsight Seeks FDA 510(k) Clearance to Market its ColonCAD(TM) Software in the U.S.
Devices Radiology Oncology FDA
 HSMN NewsFeed - 18 Nov 2008
Mylan Receives Final FDA Approval for the Generic Version of the Antidepressant Sarafem(R) Pulvules(R) Capsules
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 17 Nov 2008
Mylan Receives Tentative FDA Approval for the Generic Version of the Antidepressant Effexor XR(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 17 Nov 2008
Innocoll Receives Fast Track Designation for Gentamicin Surgical Implant
Devices Drug Delivery FDA
 HSMN NewsFeed - 13 Nov 2008
Wound Management Technologies, Inc. Announces FDA Clearance of 510k
Devices Wound Care FDA
 HSMN NewsFeed - 12 Nov 2008
Amedica Receives CE Mark for the World's First FDA-Cleared Valeo(TM) Ceramic Spinal Implant System
Devices Neurosurgery Orthopaedic Regulatory
 HSMN NewsFeed - 11 Nov 2008
TNFerade(TM) Receives FDA Fast Track Designation for Treatment of Pancreatic Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 10 Nov 2008
FDA Approves Boston Scientific's Apex(TM) PTCA Dilatation Catheter
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 6 Nov 2008
FDA Approves Additional Indication for Norditropin(R) for Small for Gestational Age (SGA) in Children
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Nov 2008
FDA Approves Ranexa(R) for First Line Anti Anginal Use and Adds New Claims for Reduction of Ventricular Arrhythmias, Bradycardia, New Atrial Fibrillation and HbA1c
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 4 Nov 2008
Mylan Receives Final Approval for First-to-File Generic Version of Antiepileptic Keppra(R) and Launches Immediately
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 4 Nov 2008
Sanvar(R) (Debio 8609) for Esophageal Variceal Bleeding - Debiopharm Submits Response to the FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 4 Nov 2008
FDA Approves Additional Indication for Norditropin(R) for Small for Gestational Age (SGA) in Children
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 3 Nov 2008
Cephalon Receives FDA Approval for TREANDA to Treat Patients with Relapsed Indolent Non-Hodgkin's Lymphoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 3 Nov 2008
APRISO(TM) Granted FDA Marketing Approval for Maintenance of Remission of Ulcerative Colitis
Biopharmaceuticals FDA
 HSMN NewsFeed - 31 Oct 2008
Pfizer's TOVIAZ(TM) (fesoterodine fumarate) Receives FDA Approval for the Treatment of Overactive Bladder
Biopharmaceuticals Urology FDA
 HSMN NewsFeed - 31 Oct 2008
Spectrum Pharmaceuticals Files Supplemental New Drug Application with FDA for FUSILEV(TM) in Colorectal Cancer
Biopharmaceuticals Oncology
 HSMN NewsFeed - 30 Oct 2008
ATS Medical Announces FDA Approval of the ATS 3f Aortic Bioprosthesis
Devices Cardiology FDA
 HSMN NewsFeed - 30 Oct 2008
Pioneer(R) Surgical Technology's NuBac(R) Nucleus Replacement Device Wins FDA Approval for IDE Pivotal Study
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 30 Oct 2008
Cardo Medical Announces FDA Clearance of the Align 360 Total Knee System
Devices Orthopaedic FDA
 HSMN NewsFeed - 29 Oct 2008
Dune Medical Launches US FDA Cleared Clinical Trial for Use of MarginProbe in Breast Cancer Surgery
Devices
 HSMN NewsFeed - 29 Oct 2008
FDA Approves Rapid-Acting Insulin Apidra(R) for Treatment of Children with Diabetes
Biopharmaceuticals FDA Endocrinology
 HSMN NewsFeed - 29 Oct 2008
Osteotech Receives FDA Clearance for its Next Generation Grafting Material
Devices FDA
 HSMN NewsFeed - 28 Oct 2008
Cook Medical Brings Power Injection Capability of Contrast Media to Spectrum(R) Antimicrobial Central Venous Catheter Line
Devices FDA
 HSMN NewsFeed - 28 Oct 2008
Bovie Medical Corporation Announces CE Mark and Submission of 510(K) Application for SEER Tissue Resection Device; Commences SEER Shipments in European Union
Devices Regulatory FDA
 HSMN NewsFeed - 28 Oct 2008
Ikonisys Receives FDA Clearance for Non-Invasive, HER-2 Breast Cancer Test
Diagnostics Oncology FDA
 HSMN NewsFeed - 28 Oct 2008
Ivera Medical Corporation Receives FDA 510(k) Clearance to Market its Curos(TM) Port Protector, an Innovative Medical Device Designed to Reduce Patient Exposure to the Risks of Hospital Acquired Bloodstream Infections
Devices FDA
 HSMN NewsFeed - 28 Oct 2008
OraSure Technologies Files For FDA Approval of OraQuick Rapid Hepatitis C Test
Diagnostics
 HSMN NewsFeed - 27 Oct 2008
FDA Approves Duramed's LoSEASONIQUE(R) Oral Contraceptive
Biopharmaceuticals FDA
 HSMN NewsFeed - 24 Oct 2008
Spiration, Inc. Receives First FDA Approval for Bronchial Valve
Devices FDA
 HSMN NewsFeed - 24 Oct 2008
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Submits New Drug Application to FDA for Carisbamate
Biopharmaceuticals Neurology
 HSMN NewsFeed - 23 Oct 2008
NanoVibronix Receives FDA Clearance for its PainShield(TM) MD Device
Devices FDA
 HSMN NewsFeed - 22 Oct 2008
AspenBio Pharma Reports on FDA 510(k) Clinical Trial Progress for AppyScore, World's First Blood-Based Diagnostic Test for Human Appendicitis
Diagnostics
 HSMN NewsFeed - 22 Oct 2008
FDA Approves Astellas' Vaprisol(R) (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Oct 2008
Merit Medical Announces 510(k) Clearance
Devices FDA
 HSMN NewsFeed - 22 Oct 2008
NeurogesX Submits NDA for NGX-4010 Dermal Capsaicin Patch for Treatment of Postherpetic Neuralgia (PHN)
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 22 Oct 2008
Medtronic Submitted Pre-Market Approval Application For FDA Approval of InterStim(R) Therapy for Fecal Incontinence
Devices FDA
 HSMN NewsFeed - 22 Oct 2008
Mylan Receives Tentative FDA Approval for First-to-File Generic Version of Blood Pressure Drug Benicar HCT(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 21 Oct 2008
Cephalon and Eurand Announce Notification of Generic Filing for Cyclobenzaprine Hydrochloride Extended-Release Capsules
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 20 Oct 2008
Cardium Announces FDA 510(K) Clearance of InnerCool's RapidBlue(TM) Endovascular System
Devices FDA
 HSMN NewsFeed - 15 Oct 2008
Integra LifeSciences Launches Accell Evo3, the Next Generation Accell Technology
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 15 Oct 2008
Amedica Receives FDA 510(k) Clearance for SEEplate(TM) Cervical Plate System
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 14 Oct 2008
RF Surgical Systems, Inc. Receives FDA Approval to Market its Blair-Port Wand(R) as a Reusable Scanning Device
Devices Surgery FDA
 HSMN NewsFeed - 14 Oct 2008
US Spine Announces FDA 510(k) Clearance for Preference 2 Complex Spine System(TM)
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 14 Oct 2008
KCI Receives FDA Clearance for its LifeCell Tissue Matrix for the Management of Wounds Utilizing Proprietary Strattice(R) Technology
Devices Wound Care FDA
 HSMN NewsFeed - 14 Oct 2008
St. Jude Medical Announces U.S. and European Approval of Angio-Seal Evolution Vascular Closure Device
Devices Interventional FDA Regulatory
 HSMN NewsFeed - 13 Oct 2008
Integrated Medical Systems Receives FDA Clearance for World's First 'Suitcase' Intensive Care Unit
Devices Monitoring FDA
 HSMN NewsFeed - 13 Oct 2008
Orthofix International Benefits From Recent Agreements And FDA Approvals
Devices Neurosurgery Orthopaedic
 HSMN NewsFeed - 10 Oct 2008
FDA Approves Bayer HealthCare's Kogenate(R) FS Treatment for Routine Prophylaxis in Children with Hemophilia A
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 Oct 2008
Boston Scientific Announces FDA Approval of Second-Generation TAXUS(R) Liberte(R) Drug-Eluting Stent
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 10 Oct 2008
W. L. Gore & Associates Receives FDA Approval for Gore EMBOLDEN Clinical Study
Devices FDA Interventional
 HSMN NewsFeed - 10 Oct 2008
FDA Approves AstraZeneca's SEROQUEL XR(R) for the Treatment of Bipolar Depression and Bipolar Mania
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Oct 2008
Watson Receives US FDA Approval for RAPAFLO(TM) (silodosin) for the Treatment of Benign Prostatic Hyperplasia (BPH)
Biopharmaceuticals FDA Urology
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