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Healthcare News Roundup: 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
 HSMN NewsFeed - 8 Oct 2008
FDA Clears NeuroStar(R) TMS Therapy for the Treatment of Depression
Devices Neurology FDA
 HSMN NewsFeed - 8 Oct 2008
Akorn, Inc. Announces the FDA Approval of Akten(TM) Ophthalmic Gel 3.5%
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 8 Oct 2008
Lumen Biomedical Receives FDA Clearance of Embolectomy System for Treatment of Peripheral Artery Disease
Devices Interventional FDA
 HSMN NewsFeed - 7 Oct 2008
Reliant Technologies Announces FDA 510(K) Clearance of New Handpieces for Skin Resurfacing and Surgical Applications
Devices Dermatology FDA
 HSMN NewsFeed - 7 Oct 2008
Advanced Medical Optics Receives FDA Approval for Healon D(R) Viscoelastic for Ophthalmic Surgery
Devices Ophthalmology FDA
 HSMN NewsFeed - 3 Oct 2008
Physio-Control Receives FDA 510(k) Clearance For LIFEPAK(R) 20e Defibrillator/Monitor
Devices FDA Monitoring
 HSMN NewsFeed - 2 Oct 2008
NeuroMetrix Receives FDA 510(k) Clearance for UNIVERSAL(TM) Electrodes used in the Performance of Nerve Conduction Studies
Devices Neurology FDA
 HSMN NewsFeed - 1 Oct 2008
Cepheid Receives FDA Clearance for First On-Demand Diagnostic Test for Life-Threatening MRSA and Staphylococcus aureus From Patient Positive Blood Cultures
Diagnostics FDA
 HSMN NewsFeed - 30 Sep 2008
Lucid Receives FDA Clearance to Market Its VivaScope(R) Reflective Confocal Microscope System in the U.S.
Devices FDA
 HSMN NewsFeed - 29 Sep 2008
FDA Grants Permission For Export of Antigenics' Oncophage(R) to Russia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 29 Sep 2008
FDA Grants Lilly's ALIMTA(R) (Pemetrexed for Injection) Third U.S. Approval
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 29 Sep 2008
Cepheid Receives FDA Clearance for First Rapid On-Demand Molecular Diagnostic Test for MRSA and S. aureus
Diagnostics FDA
 HSMN NewsFeed - 26 Sep 2008
FDA Classifies Medtronic's Notification Related to Improper Connection of Sutureless Intrathecal Catheters as a Class I Recall
Devices Product Recall
 HSMN NewsFeed - 25 Sep 2008
Boston Scientific Announces FDA Approval of TAXUS(R) Express2(TM) Atom(TM) Stent System, First Drug-Eluting Stent For Small Vessels
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 24 Sep 2008
I-Flow Corporation Receives 510(k) Clearance From FDA for Oxygenated Topical Dressing
Devices Wound Care FDA
 HSMN NewsFeed - 23 Sep 2008
Syneron(TM) Receives FDA Clearance for Versatile Matrix RF(TM) Fractional Ablative Applicator
Devices Dermatology FDA
 HSMN NewsFeed - 23 Sep 2008
Covidien Announces FDA Approval for its Generic Myocardial Perfusion Imaging Kit
Biopharmaceuticals Generics Radiology FDA
 HSMN NewsFeed - 23 Sep 2008
FDA Approves Nasacort AQ(R) Nasal Spray for Children Aged 2-5 years old
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Sep 2008
Digirad Corporation Receives FDA 510(k) Clearance for nSPEED(R) Reconstruction Software for Improved Image Quality in Less Time With Less Radiation
Devices Radiology FDA
 HSMN NewsFeed - 22 Sep 2008
Mylan Receives FDA Approval for Generic Version of Parkinson's Treatment Parcopa(R) ODT
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 22 Sep 2008
Labopharm Submits New Drug Application to FDA for DDS-04A to Treat Major Depression
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Sep 2008
Coapt Systems Launches FDA Cleared Novielle Voice (TM) for Restoration of Voice Loss
Devices
 HSMN NewsFeed - 19 Sep 2008
FDA Approves GE Healthcare's AdreView (Iobenguane I 123 Injection) Diagnostic Agent for Detecting Neuroendocrine Tumors in Children, Adults
Biopharmaceuticals Radiology FDA
 HSMN NewsFeed - 18 Sep 2008
Stem Cell Therapeutics Corp. Receives Letter From Health Canada and Verbal Request From FDA to Place a Clinical Hold on Its REGENESIS Phase IIb Stroke Trial in Canada and the US, Respectively
Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 17 Sep 2008
Gore Announces Broadened FDA Indication for GORE VIABAHN(R) Endoprosthesis for Iliac Occlusive Disease
Devices Interventional FDA
 HSMN NewsFeed - 17 Sep 2008
Ranbaxy Statement on FDA Letters
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Sep 2008
Mylan Receives FDA Approval for Generic Version of Anti-Psychotic Risperdal(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 16 Sep 2008
GSK and XenoPort Announce Submission of New Drug Application Requesting FDA Approval of Solzira(TM) for Restless Legs Syndrome
Biopharmaceuticals
 HSMN NewsFeed - 15 Sep 2008
Invitrogen, Biocare to Market FDA Approved Breast Cancer Test
Diagnostics FDA
 HSMN NewsFeed - 15 Sep 2008
FDA Approves Bausch & Lomb Akreos(TM) Advanced Optics Aspheric Lens
Devices Ophthalmology FDA
 HSMN NewsFeed - 15 Sep 2008
FDA Grants Approval to Talecris Biotherapeutics for Gamunex(R) as a Treatment for Neurological Disorder CIDP in the United States
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 15 Sep 2008
FDA Approves SANCUSO(R), the First and Only Patch for Preventing Nausea and Vomiting in Cancer Patients Undergoing Chemotherapy
Biopharmaceuticals Drug Delivery Oncology FDA
 HSMN NewsFeed - 12 Sep 2008
Sun Pharma Gets USFDA Approval for Generic Fosamax (R) Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 11 Sep 2008
FDA Classifies as a Class I Action an Urgent Medical Device Correction by Physio-Control
Devices Product Recall
 HSMN NewsFeed - 11 Sep 2008
St. Jude Medical Announces FDA Clearance of Implantable Device to Monitor Cardiac Conditions
Devices Monitoring Cardiology FDA
 HSMN NewsFeed - 10 Sep 2008
Proteon Receives FDA Fast Track Designation for First Drug Candidate PRT-201
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 Sep 2008
VioQuest Pharmaceuticals Receives 510(k) Response from FDA for Xyfid(TM)
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 9 Sep 2008
MiCardia Corporation Receives US FDA Market Clearance For Dynaplasty(TM) Annuloplasty Devices
Devices Cardiology FDA
 HSMN NewsFeed - 9 Sep 2008
FDA Approves Testing to Explore Effectiveness of Rapid Patient Cooling in Traumatic Brain Injury Cases
Devices
 HSMN NewsFeed - 5 Sep 2008
Arthrosurface HemiCAP(R) Focal Knee Resurfacing Implant Receives FDA Approval to Move into Final Investigational Stage
Devices Orthopaedic FDA
 HSMN NewsFeed - 5 Sep 2008
Positive SPA Reply From the FDA for TopoTarget's Pivotal Trial With Belinostat in PTCL
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 5 Sep 2008
Pathway Medical Technologies Receives FDA Clearance for Jetstream(TM) Pathway PV(TM) Atherectomy System
Devices Interventional FDA
 HSMN NewsFeed - 4 Sep 2008
Amgen and Wyeth Statement on the FDA Safety Announcement Regarding Tumor Necrosis Factor (TNF) Blockers
Biopharmaceuticals
 HSMN NewsFeed - 4 Sep 2008
Amrubicin Receives FDA Fast Track Designation for the Treatment of Small Cell Lung Cancer after First-Line Chemotherapy
Biopharmaceuticals FDA Oncology
 HSMN NewsFeed - 3 Sep 2008
Edwards Lifesciences Receives FDA Approval for PERIMOUNT Magna Mitral Heart Valve
Devices Cardiology FDA
 HSMN NewsFeed - 3 Sep 2008
Neurotech Granted Fast Track Designations from the FDA for NT-501 in Two Indications - Retinitis Pigmentosa and Dry Age-Related Macular Degeneration
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 2 Sep 2008
CSMG Technologies Subsidiary Live Tissue Connect Awarded European Union CE Mark Certificate; Follows Recent U.S. FDA Clearance
Devices Regulatory
 HSMN NewsFeed - 2 Sep 2008
Akorn-Strides, LLC Announces FDA Approvals for Dexamethasone Sodium Phosphate Injection USP, 4 mg (base)/mL and Dexamethasone Sodium Phosphate Injection USP, 10 mg (base)/mL
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 28 Aug 2008
Instrumentation Laboratory Receives FDA Clearance to Expand the Intended Use of HemosIL(R) D-Dimer Assay
Diagnostics FDA
 HSMN NewsFeed - 27 Aug 2008
Gleevec Receives FDA Priority Review as First Therapy to Reduce Recurrence of Gastrointestinal Stromal Tumors After Surgery
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 27 Aug 2008
FDA Clears Stereotaxis Magnetic Radio Frequency Guidewire for Peripheral Chronic Total Occlusions
Devices Interventional FDA
 HSMN NewsFeed - 26 Aug 2008
TomoTherapy Receives FDA 510(k) Clearance for TomoDirect(TM) Radiotherapy Technology
Devices Oncology FDA
 HSMN NewsFeed - 25 Aug 2008
AngioScore Submits Citizen Petition Requesting FDA Action to Deny Patent Term Extension Based on Abbott Angioplasty Catheter
Devices Interventional Cardiology
 HSMN NewsFeed - 22 Aug 2008
FDA Approves Nplate(TM) for Long-Term Treatment of Adult Chronic ITP
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Aug 2008
CMS, Inc., an Elekta Company, Receives FDA 510(k) Clearance for Atlas-Based Autosegmentation Software
Devices Oncology FDA
 HSMN NewsFeed - 21 Aug 2008
VIDAZA(R) Receives Expanded FDA Approval to Include Overall Survival in Higher-Risk MDS
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 20 Aug 2008
St. Jude Medical Announces FDA Approval of Arecibo Manufacturing Plant
Devices Cardiology FDA
 HSMN NewsFeed - 19 Aug 2008
Draeger Fabius MRI Receives FDA Clearance to Provide Advanced Anesthesia Technology in the MR Environment
Devices FDA
 HSMN NewsFeed - 18 Aug 2008
St. Jude Medical Announces CE Mark Approval and FDA Clearance for New Family of HIFU Surgical Ablation Products
Devices FDA Cardiology
 HSMN NewsFeed - 18 Aug 2008
FiatLux Imaging Receives FDA Clearance to Market FiatLux Visualize(TM), Advanced Medical Imaging Software Based on Video Game Technology Launching This Week
Devices Radiology FDA
 HSMN NewsFeed - 18 Aug 2008
Cambridge Laboratories Announces FDA Approval of XENAZINE(R) (tetrabenazine) in the US
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 15 Aug 2008
XENAZINE(R) (Tetrabenazine) Approved by FDA for Patients with Chorea Associated with Huntington's Disease
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 15 Aug 2008
IRIDEX Announces FDA Clearance for New Product Family of IRIDEX IQ Laser Systems
Devices FDA
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