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Healthcare News Roundup: FDA

 HSMN NewsFeed - 10 Aug 2010
Advanced Life Sciences Achieves Special Protocol Assessment Agreement With FDA for Restanza in Pneumonia
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 Aug 2010
FDA Approves Innovative Liver Cell Therapy for Clinical Trial in the U.S.
Regenerative Medicine FDA
 HSMN NewsFeed - 9 Aug 2010
Pfizer Receives FDA Approval for Prefilled Dual-Chamber Syringe for Use in the Treatment of Hemophilia A
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 9 Aug 2010
CryoLife Receives FDA 510(k) Clearance for CryoPatch(R) SG Pulmonary Human Cardiac Patch Shelf-life Extension
Devices Cardiology Surgery FDA
 HSMN NewsFeed - 4 Aug 2010
iCAD Announces FDA Clearance of the Company's Computer-Aided Detection Product for Virtual Colonoscopy
Devices Radiology Gastroenterology FDA
 HSMN NewsFeed - 3 Aug 2010
BioElectronics Announces New FDA Market Application to Broaden Its Prescription Clearance
Devices Wound Care Surgery FDA
 HSMN NewsFeed - 2 Aug 2010
FDA Approves Merz Pharmaceuticals' Xeomin(R) (incobotulinumtoxinA) for the Treatment of Cervical Dystonia and Blepharospasm
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 2 Aug 2010
Sagent Pharmaceuticals Announces Two New FDA Approvals: Sumatriptan Succinate Injection and Rocuronium Bromide Injection
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Aug 2010
EnteroMedics Achieves Major Milestones in Global Regulatory and Commercialization Strategy for the Maestro System
Devices Gastroenterology FDA
 HSMN NewsFeed - 30 Jul 2010
ZOLL Propaq MD Monitor/Defibrillator Granted 510(k) Clearance by U.S. Food and Drug Administration
Devices Monitoring FDA
 HSMN NewsFeed - 30 Jul 2010
Hotspur Technologies Receives FDA 510(k) Clearance for First Three Product Lines Based on the Company's Unique Technology
Devices FDA
 HSMN NewsFeed - 29 Jul 2010
Boston Scientific Announces FDA Approval of New Leads for the Precision Plus Spinal Cord Stimulator System
Devices Neurology FDA
 HSMN NewsFeed - 29 Jul 2010
Endologix Receives FDA Approval for PowerFit Aortic Extensions
Devices Interventional FDA
 HSMN NewsFeed - 29 Jul 2010
Shionogi Inc. Announces FDA Approval of CUVPOSA for the Treatment of Chronic Severe Drooling in Pediatric Patients With Neurologic Conditions
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 Jul 2010
FDA Advisory Committee Recommends US FDA Approval of Brilinta (Ticagrelor) for Acute Coronary Syndromes
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 29 Jul 2010
Abbott's SIMCOR(R) (niacin extended-release / simvastatin) Receives FDA Approval for New Dosage Strengths
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 27 Jul 2010
Medtronic's AMPLIFY rhBMP-2 Matrix Receives Positive Votes from FDA Advisory Panel on All Three Key Questions: Safety, Effectiveness and Benefit/Risk
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 27 Jul 2010
Instrumentation Laboratory Receives FDA Clearance for New Automated Total Bilirubin Assay on GEM Premier 4000 Critical Care Analyzer
Diagnostics FDA
 HSMN NewsFeed - 27 Jul 2010
WorldHeart Receives FDA Approval to Add Clinical Sites in Levacor(TM) VAD Bridge-to-Transplant Study
Devices Cardiology FDA
 HSMN NewsFeed - 26 Jul 2010
Roche Receives FDA Clearance for CoaguChek XS Pro system With Bar Code Reader for PT/INR Testing at the Point of Care
Diagnostics FDA
 HSMN NewsFeed - 26 Jul 2010
FDA Approves Tribenzor, A New Three-In-One Combination Product for the Treatment of High Blood Pressure
Biopharmaceuticals FDA
 HSMN NewsFeed - 24 Jul 2010
Eisai Inc. and Pfizer Inc Announce U.S. FDA Approval for New Higher-Dose Aricept(R) (donepezil HCl) 23 mg Tablet for the Treatment of Moderate-to-Severe Alzheimer's Disease
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 22 Jul 2010
FDA provides Complete Response Letter to NicOx's New Drug Application for naproxcinod
Biopharmaceuticals
 HSMN NewsFeed - 21 Jul 2010
BSD Medical Provides Information Requested by FDA for the MicroThermX Ablation System 510(k) Submission
Devices Oncology FDA
 HSMN NewsFeed - 19 Jul 2010
Cardiac Science Addresses FDA Recall Concerns
Devices Cardiology Product Recall
 HSMN NewsFeed - 19 Jul 2010
NovaVision's FDA-Cleared Visual Restoration Therapy (VRT) System and Company Assets Now Available
Devices
 HSMN NewsFeed - 16 Jul 2010
Sun Pharma Announces USFDA Approval for Generic Flomax(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 14 Jul 2010
Mylan Receives Approval for Nabumetone Tablets
Biopharmaceuticals FDA
 HSMN NewsFeed - 14 Jul 2010
Aeterna Zentaris Announces Perifosine Has Received Orphan-Drug Designation for the Treatment of Neuroblastoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 12 Jul 2010
Catheter Connections Receives 510(k) Clearance From FDA For DualCap Vascular Access Disinfecting Cap
Devices FDA
 HSMN NewsFeed - 9 Jul 2010
Derma Sciences Submits 510(k) Application for MEDIHONEY Gel, Reaches Goal of 20-Person U.S. Field Sales Force
Devices Wound Care FDA
 HSMN NewsFeed - 7 Jul 2010
Ethicon, Inc. Expands Hemostasis Product Portfolio with Approval of the Company's First Synthetic Internal Use Sealant
Devices FDA
 HSMN NewsFeed - 7 Jul 2010
MonoSol Rx Announces FDA Approval of Zuplenz(R) Oral Soluble Film for Treatment of Nausea and Vomiting
Biopharmaceuticals Drug Delivery Oncology FDA
 HSMN NewsFeed - 7 Jul 2010
Genentech Submits Application to FDA for Trastuzumab-DM1 in Previously Treated Advanced HER2-Positive Breast Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 6 Jul 2010
VisionCare Announces FDA Approval for First-Ever Implantable Telescope for End-Stage Macular Degeneration
Devices Ophthalmology FDA
 HSMN NewsFeed - 6 Jul 2010
Three Rivers Pharmaceuticals Announces FDA Approval Of Expanded Labeling of INFERGEN
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Jul 2010
FDA Approves Sagent Pharmaceuticals' Heparin Sodium Injection, USP
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Jul 2010
Cyclacel Pharmaceuticals Announces FDA Orphan Drug Designation for Sapacitabine in Both AML and MDS
Biopharmaceuticals Oncology
 HSMN NewsFeed - 1 Jul 2010
Eisai to Market Arena Pharmaceuticals' Lorcaserin for Obesity and Weight Management in U.S. Following FDA Approval
Biopharmaceuticals
 HSMN NewsFeed - 30 Jun 2010
AMS Receives 510(k) Clearance of Its Revolutionary MoXy(TM) Liquid Cooled Fiber for Fast, Safe Treatment of Enlarged Prostate
Devices Urology FDA
 HSMN NewsFeed - 29 Jun 2010
Mylan Receives Approval for Generic Version of Arimidex(R) Tablets
Biopharmaceuticals Oncology Generics FDA
 HSMN NewsFeed - 29 Jun 2010
Teva Announces Approval of Generic Effexor XR(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 28 Jun 2010
American Medical Systems Announces FDA Clearance for MiniArc(R) Precise Single-Incision Sling
Devices Urology FDA
 HSMN NewsFeed - 28 Jun 2010
Abbott Receives FDA Clearance for Molecular Diagnostic Test for Detection of Chlamydia and Gonorrhea Infections
Diagnostics FDA
 HSMN NewsFeed - 25 Jun 2010
OraSure Technologies Receives FDA Approval for OraQuick(R) HCV Rapid Test, the First Rapid HCV Test Approved for Sale in the U.S.
Diagnostics FDA
 HSMN NewsFeed - 24 Jun 2010
Boston Scientific Announces FDA Approval and Launch of Lead Splitters for the Precision Plus Spinal Cord Stimulator System
Devices FDA
 HSMN NewsFeed - 24 Jun 2010
FDA Approves Merck's DULERA(R) (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol for the Treatment of Asthma in Patients 12 Years of Age and Older
Biopharmaceuticals FDA
 HSMN NewsFeed - 24 Jun 2010
t2cure's Cellular Therapeutic Receives Orphan Drug Designation from FDA, EMA Recommendation for Buerger's Disease
Biopharmaceuticals Regenerative Medicine FDA Regulatory
 HSMN NewsFeed - 23 Jun 2010
Biosense Webster Receives FDA Clearances for the CARTOXPRESS Software Module and LASSO(R) NAV Catheter for its CARTO(R) XP System
Devices Cardiology FDA
 HSMN NewsFeed - 22 Jun 2010
Hospira Receives FDA Approval for Meropenem for Injection, USP (I.V.)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 21 Jun 2010
Pathway Medical Technologies Receives FDA 510(k) Clearance for JETSTREAM G3 SF Atherectomy System
Devices Interventional FDA
 HSMN NewsFeed - 21 Jun 2010
U.S. FDA Approves Improved Performance of Riverain Medical's OnGuard Chest X-ray Computer-Aided Detection Technology
Devices FDA Radiology
 HSMN NewsFeed - 21 Jun 2010
FDA Approves First-of-Its-Kind HIV Test Which Can Detect HIV Days Earlier Than Current U.S. Tests
Diagnostics HIV/AIDS FDA
 HSMN NewsFeed - 21 Jun 2010
EarlySense's New EverOn(R) Touch System Receives FDA Clearance
Devices FDA
 HSMN NewsFeed - 21 Jun 2010
PolyTouch Medical Ltd. Receives FDA Clearance to Commercialize PatchAssist(TM) - an Innovative Surgical Instrument Intended to Facilitate the Delivery of Soft Tissue Prosthetics During the Laparoscopic Repair of Soft Tissue Defects
Devices Surgery FDA
 HSMN NewsFeed - 21 Jun 2010
APP Pharmaceuticals Announces Approval and Launch of First Generic Aztreonam for Injection, USP
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 16 Jun 2010
SanBio Receives FDA Clearance to Initiate Cell Therapy Clinical Studies for Stroke Recovery
Regenerative Medicine Neurology 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
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