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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 - 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
deCODE Files IND for DG071, a Novel PDE4 Modulator Being Developed for Alzheimer's and Other Cognitive Disorders
Biopharmaceuticals Neurology 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
Orthofix International Receives 510(k) Approval For Next Generation Lumbar Fixation System
Devices Orthopaedic Neurosurgery FDA
 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 - 2 Oct 2008
Apollo Endosurgery Announces 510(k) Clearance for Its Flexible Endoscopic Suturing System
Devices Surgery FDA
 HSMN NewsFeed - 1 Oct 2008
Transcept Pharmaceuticals Submits New Drug Application for Intermezzo(R) for Treatment of Middle-of-the-Night Awakenings
Biopharmaceuticals Drug Delivery 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
Alphatec Spine Announces 510(k) Clearance for Its Novel Cervical Interbody Implant
Devices Neurosurgery Orthopaedic FDA
 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
US Court Denies Teva's Motion for Summary Judgment in PULMICORT RESPULES(R) Patent Litigation
Biopharmaceuticals Generics 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
Radi Medical Systems Inc. Announces Regulatory Clearance of PressureWire(R) Certus for Physiological Parameter Measurements Inside the Heart
Devices Cardiology 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 - 22 Sep 2008
IDEV Technologies Inc. and YMED Inc. Announce 510(k) Clearance for Larger and Longer Sizes of The VascuTRAK2(TM) PTA Dilation Catheter for the Treatment of Peripheral Artery Disease
Devices Interventional 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 - 16 Sep 2008
Intact Medical Corporation's Intact(R) Excise XL Receives 510(K) Marketing Clearance from the FDA
Devices FDA
 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
Masimo Initiates Limited Release of First-Ever Noninvasive and Continuous Hemoglobin Monitors
Devices Monitoring 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 - 15 Sep 2008
Keppra XR(TM) Approved in the U.S.
Biopharmaceuticals Neurology 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 - 9 Sep 2008
Pfizer Will Withdraw Global Marketing Applications for Dalbavancin to Conduct a New Trial
Biopharmaceuticals Regulatory FDA
 HSMN NewsFeed - 9 Sep 2008
Cardica Receives 510(k) Clearance to Market PAS-Port(R) Proximal Anastomosis System for Use in Cardiac Bypass Surgery
Devices Cardiology FDA
 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
Orthofix International Announces Expansion of Product Offerings
Devices Orthopaedic Neurosurgery 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
Pioneer(R) Surgical Technology Receives 510(k) Clearance to Market FortrOss(TM), A Next Generation Bone Void Filler
Devices Orthopaedic FDA
 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 - 3 Sep 2008
CONMED Launches Multiple New Gastrointestinal Endoscopy Products
Devices Surgery FDA
 HSMN NewsFeed - 2 Sep 2008
Taking the Gold with Silver: B. Braun Introduces Industry-First Silver Impregnated Needle-Free Luer Access Device
Devices 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 - 27 Aug 2008
XDx's AlloMap(R) Gene Expression Test Cleared by U.S. Food and Drug Administration (FDA)
Diagnostics FDA
 HSMN NewsFeed - 26 Aug 2008
TomoTherapy Receives FDA 510(k) Clearance for TomoDirect(TM) Radiotherapy Technology
Devices Oncology FDA
 HSMN NewsFeed - 26 Aug 2008
Alsius Corporation Receives 510(K) Market Clearance for Solex(TM) Catheter
Devices 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
Barr Announces Approval of Generic Aredia(R) Injection, 30mg/mL, 60mg/mL and 90mg/mL Injectable
Biopharmaceuticals Generics 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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