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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 - 29 Mar 2007
FDA Announces Voluntary Withdrawal of Pergolide Products
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 29 Mar 2007
Aspect Medical Systems Provides Commentary at FDA Meeting about Preclinical Neurotoxicity of Anesthetic Drug Products
Devices Monitoring Neurology FDA
 HSMN NewsFeed - 29 Mar 2007
NEOPHARM Reports on FDA Meeting
Biopharmacetuticals Oncology FDA
 HSMN NewsFeed - 28 Mar 2007
Cutera Receives FDA Clearance for Its New Laser, Pearl, Using YSGG Technology
Devices Dermatology FDA
 HSMN NewsFeed - 28 Mar 2007
CardioMEMS, Inc. Announces FDA Clearance of the EndoSure Wireless AAA Pressure Measurement System for Measuring Intrasac Pressure During Thoracic Aortic Aneurysm (TAA) Repair
Devices Surgery Monitoring FDA
 HSMN NewsFeed - 28 Mar 2007
FDA Accepts Synthemed's Pre-Market Approval (PMA) Application for REPEL-CV(R)
Devices Surgery FDA
 HSMN NewsFeed - 28 Mar 2007
CryoCath receives FDA approval to expand STOP AF trial to full cohort of patients
Devices Cardiology FDA
 HSMN NewsFeed - 27 Mar 2007
U.S. District Court Enjoins the FDA from Approving Additional Amlodipine Besylate ANDAs
Biopharmaceuticals Generics FDA Litigation
 HSMN NewsFeed - 27 Mar 2007
Nuvelo Receives FDA Fast Track Status for rNAPc2 in Both First- and Second-Line Treatment of Metastatic Colorectal Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 26 Mar 2007
Roche Submits Application to the FDA for use of XELOX (Xeloda(R) plus oxaliplatin) With or Without Avastin(R) for the Treatment of Advanced Colorectal Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 26 Mar 2007
Wyeth Receives FDA Approval for New BeneFIX Features That Provide Hemophilia B Patients a Simpler and More Convenient Preparation Process for Recombinant Factor IX
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Mar 2007
CISBIO Announces FDA Approval of MESOMARK(R) Assay Now Availabe to Physicians in the U.S. for Monitoring Patients with Mesothelioma
Diagnostics Oncology FDA
 HSMN NewsFeed - 22 Mar 2007
Cardima PMA for Treatment of Atrial Fibrillation Symptoms to Be Reviewed by FDA Dispute Resolution Panel
Devices Cardiology FDA
 HSMN NewsFeed - 21 Mar 2007
Diamics Receives FDA Clearance for Revolutionary New Cervical Sample Collection System
Devices Diagnostics Oncology FDA
 HSMN NewsFeed - 21 Mar 2007
Updated Varian Brachytherapy Applicator Set for Esophagus Cancer Treatment Receives FDA 510k Clearance
Devices Oncology FDA
 HSMN NewsFeed - 20 Mar 2007
St. Jude Medical Announces FDA Approval of First U.S. Heart Failure Device with AF Suppression Technology
Devices Cardiology FDA
 HSMN NewsFeed - 19 Mar 2007
MedicalCV, Inc. Receives FDA 510(k) Clearance for Its SOLAR(TM) Surgical Ablation System
Devices FDA
 HSMN NewsFeed - 19 Mar 2007
Cepheid's Xpert(TM) EV Test for Enteroviral Meningitis, Run on the GeneXpert Platform, Receives FDA Clearance
Diagnostics FDA
 HSMN NewsFeed - 19 Mar 2007
Update: FDA Approves Alexion's Soliris(TM) for All Patients With PNH
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Mar 2007
FDA Approves Alexion's Soliris(TM) for All Patients With PNH
Biopharmaceuticals FDA
 HSMN NewsFeed - 15 Mar 2007
Neose Receives FDA Clearance to Commence U.S. Clinical Trials for NE-180
Biopharmaceuticals
 HSMN NewsFeed - 14 Mar 2007
Onset Medical Receives FDA Clearance to Market SoloPath(TM) Percutaneous Transseptal Access Catheter
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 14 Mar 2007
Mylan Announces Tentative FDA Approval for Divalproex Sodium Extended-Release Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 13 Mar 2007
FDA Approves TYKERB(R) (lapatinib) in Combination With Xeloda(R) (capecitabine) for the Treatment of Advanced or Metastatic Breast Cancer in Women Who Have Progressed on Prior Therapy
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 13 Mar 2007
PARI's Hydrate Receives FDA 510k Clearance
Devices FDA
 HSMN NewsFeed - 12 Mar 2007
Exactech, Inc. Cleared by FDA for U.S. Distribution of Equinoxe(R) Reverse Shoulder
Devices Orthopaedic FDA
 HSMN NewsFeed - 12 Mar 2007
Cangene receives an approvable letter from the FDA for human growth hormone
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Mar 2007
FDA Approves New Medtronic Continuous Glucose Monitoring Devices for Children and Teenagers
Devices FDA Endocrinology
 HSMN NewsFeed - 7 Mar 2007
Nuvo announces further update on discussions with the FDA related to review of Pennsaid
Biopharmaceuticals
 HSMN NewsFeed - 7 Mar 2007
BSD Medical Comments on FDA Warning Letter Regarding Clinical Study
Devices Oncology FDA
 HSMN NewsFeed - 7 Mar 2007
Lipitor Receives FDA Approval for Five New Indications in Patients With Heart Disease
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 7 Mar 2007
Respironics Receives 510(k) Clearance from FDA for BiPAP(R) autoSV(TM) Device Designed for Complicated Sleep-Disordered Breathing Patients
Devices FDA
 HSMN NewsFeed - 7 Mar 2007
Spacelabs Healthcare Announces FDA Clearance for U.S. Sale and Distribution of Diagnostic Cardiology Data Management System
Devices Cardiology Monitoring FDA
 HSMN NewsFeed - 6 Mar 2007
Aethlon Medical Announces FDA Submission
Devices FDA
 HSMN NewsFeed - 5 Mar 2007
Focus Diagnostics Receives FDA Clearance to Market Plexus HerpeSelect
Diagnostics FDA
 HSMN NewsFeed - 5 Mar 2007
Medtronic Submits Pre-Market Approval Application to the FDA for the Talent(TM) Thoracic Stent Graft System
Devices Interventional
 HSMN NewsFeed - 5 Mar 2007
Elbit Medical Group Announces FDA Approval of New Version of InSightec's ExAblate(R) 2000 That Speeds Up Treatment Time and the Use of ExAblate 2000 System With GE Healthcare's 3 Tesla Magnetic Resonance Imaging System
Devices FDA
 HSMN NewsFeed - 3 Mar 2007
MAQUET Critical Care Receives FDA 510(K) Clearance for New Option Allowing Use of its Servo-I Ventilator During MR Exams
Devices FDA
 HSMN NewsFeed - 2 Mar 2007
FDA Approves Gen-Probe's TIGRIS(R) Instrument to Screen Donated Blood for West Nile Virus
Diagnostics FDA
 HSMN NewsFeed - 2 Mar 2007
FDA Approves Astellas' Vaprisol(R) for the Treatment of Hypervolemic Hyponatremia
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Mar 2007
FDA Grants Pediatric Exclusivity for RISPERDAL(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Mar 2007
FDA Approves use of InSightec's ExAblate(R) 2000 With GE Healthcare's 3 Tesla Magnetic Resonance Imaging System
Devices FDA
 HSMN NewsFeed - 1 Mar 2007
FDA Approves New Version of InSightec's ExAblate(R) 2000 That Speeds up Treatment Time
Devices FDA
 HSMN NewsFeed - 1 Mar 2007
FDA Approves Alpharma's KADIAN(R) New 200 Mg Strength
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Feb 2007
FDA Approves First Medication to Treat and Prevent Vomiting in Dogs
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Feb 2007
King Pharmaceuticals Announces FDA Approval of ALTACE(R) Tablet Formulation
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Feb 2007
AVANIR Pharmaceuticals Summarizes Outcome of FDA Meeting on Zenvia NDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Feb 2007
Advancis Pharmaceutical Reaches Agreement with FDA for Resubmission of Amoxicillin PULSYS NDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Feb 2007
HUMIRA(R) (Adalimumab) Receives FDA Approval For Treatment of Crohn's Disease
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 27 Feb 2007
Baxter Receives 510(k) Clearance From FDA For COLLEAGUE Infusion Pumps
Devices FDA
 HSMN NewsFeed - 26 Feb 2007
Mylan Announces Tentative FDA Approval for Ondansetron Orally Disintegrating Tablets, USP
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 26 Feb 2007
FDA Approves Cymbalta(R) for Treatment of Generalized Anxiety Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Feb 2007
St. Jude Medical Receives FDA Clearance for Venture Catheter with New Delivery Platform
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 21 Feb 2007
King Pharmaceuticals Announces FDA Approval of New Bicillin(R) Manufacturing Facility
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Feb 2007
Theravance Announces FDA Acceptance of Telavancin NDA
Biopharmaceuticals
 HSMN NewsFeed - 20 Feb 2007
Meridian Bioscience Receives FDA Clearance for New E. coli Test
Diagnostics FDA
 HSMN NewsFeed - 16 Feb 2007
Biogel(R) Gloves Have Met Newest FDA Guidelines for Many Years
Devices
 HSMN NewsFeed - 16 Feb 2007
FDA Fast Tracks Medical Device Designed for U.S. Military
Devices
 HSMN NewsFeed - 16 Feb 2007
Mylan Announces Final FDA Approval for Propranolol Hydrochloride Extended-Release Capsules, USP
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 15 Feb 2007
CryoCor PMA to be Reviewed at FDA Panel
Devices Cardiology FDA
 HSMN NewsFeed - 15 Feb 2007
PLUS Orthopedics USA, Inc. Announces FDA Clearance and Market Availability of Next-Generation Computer-Assisted Orthopedic Surgery System
Devices Orthopaedic FDA
 HSMN NewsFeed - 15 Feb 2007
St. Jude Medical Announces FDA Clearance of Spinal Cord Stimulation Leads for Patients with Low Back Pain
Devices Neurology FDA
 HSMN NewsFeed - 15 Feb 2007
FDA Accepts Two Supplemental New Drug Applications to Expand the U.S. Labeling for JANUVIA(TM)
Biopharmaceuticals Endocrinology
 HSMN NewsFeed - 14 Feb 2007
Rcadia Cardiac COR Analyzer Receives FDA Clearance
Diagnostics Cardiology Radiology
 HSMN NewsFeed - 13 Feb 2007
Advancis Pharmaceutical Announces FDA Decision That its Amoxicillin PULSYS NDA is Not Complete
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Feb 2007
Osteotech Receives FDA Clearance for First Product Under Its Plexus Technology Platform
Devices
 HSMN NewsFeed - 8 Feb 2007
Pfizer's Sutent Receives FDA Approval to Include New First-Line Advanced Kidney Cancer Data in Label
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 8 Feb 2007
Vital Signs Announces FDA Clearance for iSleep 20i Intelligent CPAP Device and Letter of Intent to Acquire Sleep Diagnostic Business
Devices FDA
 HSMN NewsFeed - 8 Feb 2007
Mylan Announces Final FDA Approval for Sotalol Hydrochloride Tablets, USP (AF)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 7 Feb 2007
Datascope Receives FDA Clearance to Include Depth-of-Anesthesia Monitoring in the Spectrum(R) OR Monitor
Devices Monitoring FDA
 HSMN NewsFeed - 7 Feb 2007
FDA Grants Priority Review to Lovenox(R) (Enoxaparin Sodium Injection) Supplemental New Drug Application (sNDA) for Acute Heart Attack
Biopharmaceuticals Cardiology
 HSMN NewsFeed - 7 Feb 2007
Paradigm Medical Receives FDA Approval for New-Generation Ultrasound Devices
Devices Ophthalmology FDA
 HSMN NewsFeed - 7 Feb 2007
IRIS Submits 510(k) Application To FDA For Its N.A.D.I.A. Prostate Cancer Test
Diagnostics Oncology FDA
 HSMN NewsFeed - 7 Feb 2007
Pro-Pharmaceuticals' Begins Process of New Drug Application Submission with the FDA for Co-administration of DAVANAT(R) with 5-FU in Cancer Patients
Biopharmaceuticals Oncology
 HSMN NewsFeed - 7 Feb 2007
Anesiva Announces FDA Acceptance for Filing of Zingo(TM) New Drug Application to Reduce Pain Associated With Needle Insertion Procedures in Children
Biopharmaceuticals
 HSMN NewsFeed - 6 Feb 2007
Baxter Receives Clearance From U.S. FDA for Ipump Pain Management System 510(k)
Devices FDA
 HSMN NewsFeed - 6 Feb 2007
Mylan Announces Final FDA Approval for Sertraline Hydrochloride Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 6 Feb 2007
Agendia Receives U.S. FDA Clearance for MammaPrint Breast Cancer Diagnostic Test
Diagnostics FDA
 HSMN NewsFeed - 6 Feb 2007
Cardinal Health Announces Agreement With FDA on Alaris(R) SE Infusion Pump
Devices FDA
 HSMN NewsFeed - 6 Feb 2007
AtriCure Receives FDA 510(k) Clearance for Isolator(TM) Synergy(TM) Bipolar Ablation System and Performs First Case
Devices FDA
 HSMN NewsFeed - 6 Feb 2007
Genta Announces the Company Will Appeal FDA Action on New Drug Application of Genasense(R) in Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology
 HSMN NewsFeed - 5 Feb 2007
Life Spine Announces FDA Approval of Pilot(R) Rod System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 5 Feb 2007
Barnev Inc. Announces FDA Approval of the Computerized Labor Monitoring System (CLM)
Devices Monitoring FDA
 HSMN NewsFeed - 5 Feb 2007
Merci(R) L5 Retriever from Concentric Medical Receives FDA Clearance for Neurovascular Clot Retrieval in Stroke Patients
Devices Interventional Neurology FDA
 HSMN NewsFeed - 2 Feb 2007
FDA Approves New Dosing Recommendations for RAPAMUNE in High Immunologic Risk Renal Transplant Patients
Biopharmaceuticals FDA
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