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Healthcare News Roundup: FDA

 HSMN NewsFeed - 28 Mar 2007
ATS Medical Announces US IDE Regulatory Submission for the ATS 3f Enable(TM) Aortic Bioprosthesis
Devices Cardiology 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
Daiichi Sankyo, Inc. Announces Filing For WelChol Label Change to Include Ezetimibe Efficacy Data
Biopharmaceuticals 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
Mylan Announces Another First to Market With the Launch of Ciprofloxacin Extended-Release Tablets
Biopharmaceuticals Generics 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 - 22 Mar 2007
ZOLL Receives Marketing Clearance for M Series with Real CPR Help Technology
Devices Cardiology FDA
 HSMN NewsFeed - 22 Mar 2007
Abaxis Announces CLIA Waived Status for Two Additional Medical Test Panels
Diagnostics FDA
 HSMN NewsFeed - 22 Mar 2007
American Medical Systems Has Initiated a Clinical Evaluation for a New Minimally Invasive Sling Intended to Treat Female Stress Urinary Incontinence
Devices Urology FDA
 HSMN NewsFeed - 21 Mar 2007
Synovics Pharmaceuticals Files ANDA for Generic Hydroxyzine
Biopharmaceuticals Generics 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
Artes Medical Submits Five Year Artefill(R) Clinical Results to FDA
Devices Dermatology
 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
Keppra(R) Approved for US Epilepsy Patients with One of the Most Debilitating Seizure Types
Biopharmaceuticals Neurology 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 - 20 Mar 2007
Cell Therapeutics Inc. (CTI) Files for Special Protocol Assessment (SPA) for XYOTAX(TM) PGT307 Lung Cancer Trial in Women
Biopharmaceuticals Oncology 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 - 16 Mar 2007
Irvine Scientific Launches Their New SIS/AI Catheter
Devices FDA
 HSMN NewsFeed - 16 Mar 2007
Endo and Vernalis plc Announce Three-Month Extension of PDUFA Date for Frova(R) sNDA
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
PreMD Provides Update on 510(k) Application for PREVU(x) LT
Diagnostics FDA
 HSMN NewsFeed - 13 Mar 2007
PARI's Hydrate Receives FDA 510k Clearance
Devices FDA
 HSMN NewsFeed - 13 Mar 2007
Medtronic Receives Approval to Market INFUSE Bone Graft for Certain Oral Maxillofacial and Dental Regenerative Applications
Devices Orthopaedic FDA
 HSMN NewsFeed - 13 Mar 2007
Cell Therapeutics, Inc. (CTI) Files for Special Protocol Assessment (SPA) for Pixantrone in Relapsed Indolent Non-Hodgkin's Lymphoma (NHL)
Biopharmaceuticals Oncology 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 - 12 Mar 2007
Depomed Files Investigational New Drug Application for Gabapentin GR for the Treatment of Postmenopausal Hot Flashes
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 9 Mar 2007
Ortho Biotech Revises Prescribing Information for PROCRIT(R) (Epoetin alfa)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 9 Mar 2007
Amgen Announces Update To U.S. Prescribing Information for Aranesp(R) and EPOGEN(R)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 9 Mar 2007
Teva Receives First U.S. Approval for Generic Uniretic(R) Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 8 Mar 2007
Teva Receives Approval for Generic Dostinex(R) Tablets
Biopharmaceuticals Generics FDA
 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 - 6 Mar 2007
Tekturna(R) - The First New Type of High Blood Pressure Medicine In More Than a Decade - Receives Its First Approval in the US
Biopharmaceuticals Cardiology 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
Teva Announces Approval of Alprazolam ER Tablets
Biopharmaceuticals Generics 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
Haemonetics(R) Launches Next Generation Mobile Blood Donation System
Devices FDA
 HSMN NewsFeed - 1 Mar 2007
FDA Approves Alpharma's KADIAN(R) New 200 Mg Strength
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Mar 2007
Actavis Receives Approval for Ranitidine Syrup in the U.S.
Biopharmaceuticals Generics 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
EPIX Pharmaceuticals Files Formal Appeal for Vasovist(TM) with the Center for Drug Evaluation and Research
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
Ortec Initiates Premarket Approval (PMA) Application Filing Seeking Approval for OrCel(R) in Treating Venous Leg Ulcers
Regenerative Medicine Wound Care FDA
 HSMN NewsFeed - 26 Feb 2007
FDA Approves Cymbalta(R) for Treatment of Generalized Anxiety Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Feb 2007
Taro Receives Tentative Approval for Ranitidine Syrup ANDA
Biopharmaceuticals Gastroenterology Generics FDA
 HSMN NewsFeed - 23 Feb 2007
Pro-Pharmaceuticals Meeting Scheduled with the FDA
Biopharmaceuticals Oncology
 HSMN NewsFeed - 22 Feb 2007
Valeant Pharmaceuticals Files Investigational New Drug Application for Cesamet(R) in Cancer Chemotherapy-Induced Neuropathic Pain
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Feb 2007
Teva Announces Approval of Rabeprazole Sodium Delayed-Release Tablets
Biopharmaceuticals Generics 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 - 21 Feb 2007
Pharmacyclics Receives Refuse to File Letter for Xcytrin
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 21 Feb 2007
BioMimetic Therapeutics Receives Orphan Drug Designation for rhPDGF-BB Treatment of Osteonecrosis of the Jaw
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Feb 2007
Theravance Announces FDA Acceptance of Telavancin NDA
Biopharmaceuticals
 HSMN NewsFeed - 20 Feb 2007
New Storage Instructions Approved for BYETTA(R)
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 20 Feb 2007
Meridian Bioscience Receives FDA Clearance for New E. coli Test
Diagnostics FDA
 HSMN NewsFeed - 20 Feb 2007
Milestone Scientific Launches FDA-Cleared Single Tooth Anesthesia (STA(TM)) System During Chicago Midwinter Meeting
Devices Dental Drug Delivery
 HSMN NewsFeed - 20 Feb 2007
Cyberkinetics Files to Market Andara(TM) OFS(TM) Therapy for Acute Spinal Cord Injury under Humanitarian Device Exemption
Devices Neurology Regenerative Medicine 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 - 16 Feb 2007
GPC Biotech Submits NDA for Lead Oncology Drug Candidate Satraplatin
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Feb 2007
Spectrum Pharmaceuticals Announces Completion of NDA Filing for Satraplatin for Hormone Refractory Prostate Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 15 Feb 2007
CryoCor PMA to be Reviewed at FDA Panel
Devices Cardiology FDA
 HSMN NewsFeed - 15 Feb 2007
New Version of Devices to Treat Clogged Neck Arteries Approved by U.S. Food and Drug Administration
Devices Interventional 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
Actavis Launches Alprazolam ER Tablets in the U.S.
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 14 Feb 2007
Scient'x USA Announces 510(K) Clearance for Isobar LP(R) Low Profile Pedicle Screw System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 14 Feb 2007
Rcadia Cardiac COR Analyzer Receives FDA Clearance
Diagnostics Cardiology Radiology
 HSMN NewsFeed - 14 Feb 2007
Integra LifeSciences Launches TenoGlide Tendon Protector Sheet
Devices FDA
 HSMN NewsFeed - 13 Feb 2007
Advancis Pharmaceutical Announces FDA Decision That its Amoxicillin PULSYS NDA is Not Complete
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Feb 2007
N Spine Receives 510(k) Clearance of Its NFix II Dynamic Stabilization System for the Lumbar Spine
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 13 Feb 2007
FDA-approved Ostene, Made by Ceremed Inc. and Designed for Use in Cardiac Surgery, May Reduce Serious Post-operative Complications in Heart Patients
Devices Surgery
 HSMN NewsFeed - 13 Feb 2007
Seattle Genetics Receives Orphan Drug Designations for its SGN-33 and SGN-35 Programs
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Feb 2007
Integra LifeSciences Announces the Launch of the Mid and Hind Foot Plating Systems
Devices Orthopaedic FDA
 HSMN NewsFeed - 12 Feb 2007
sanofi-aventis Announces Update to U.S. Prescribing Information for Ketek(R) (Telithromycin)
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Feb 2007
Integra LifeSciences Announces the Launch of Integra Mozaik Osteoconductive Scaffold
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 9 Feb 2007
Scient'x USA Announces 510(K) Clearance For Antelys GX(R) PEEK VBR System
Devices Orthopaedic Neurosurgery 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
Ranbaxy Gains Final Approval for Sertraline Hydrochloride Tablets
Biopharmaceuticals Generics 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
Biogen Idec Initiates Randomized, Registrational Trial of Lumiliximab for Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 7 Feb 2007
Portable Somnoscreen Sleep-Monitoring System (Somnoscreen PSG) Approved for U.S. Sales
Devices Monitoring 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
ViroPharma Receives Orphan Drug Designation for Maribavir for Cytomegalovirus Viremia and Disease Indication
Biopharmaceuticals 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
STAAR Surgical Provides Update on Toric ICL Application With FDA
Devices Ophthalmology
 HSMN NewsFeed - 6 Feb 2007
Barr's Subsidiary PLIVA Receives Final Approval for Generic ZOLOFT(R) Tablets, 25 mg, 50 mg and 100 mg
Biopharmaceuticals Generics 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
Abdominal Surgical Procedures Without Skin Incisions
Devices Surgery 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 - 5 Feb 2007
Orthovita Confirms That 510(k) Submission May Be Used to Seek Clearance for CORTOSS(R) Bone Augmentation Material for the Treatment of Vertebral Compression Fractures
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 2 Feb 2007
FDA Approves New Dosing Recommendations for RAPAMUNE in High Immunologic Risk Renal Transplant Patients
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Feb 2007
BDSI Announces FDA Acceptance of Bioral(R) Amphotericin IND
Biopharmaceuticals Drug Delivery
 HSMN NewsFeed - 2 Feb 2007
GlaxoSmithKline Receives Approvable Letter for New Indications for ARIXTRA(R) (Fondaparinux Sodium) Injection
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 2 Feb 2007
DRAXIS Radiopharmaceuticals Division Applies to FDA to Market Cardiac Imaging Product
Biopharmaceuticals Generics Radiology
 HSMN NewsFeed - 1 Feb 2007
Alcon's AcrySof(R) ReSTOR(R) Apodized Diffractive Aspheric Intraocular Lens Approved by FDA
Devices Ophthalmology FDA
 HSMN NewsFeed - 1 Feb 2007
Grifols Announces FDA Approval of Alphanate(R) to Treat von Willebrand Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Feb 2007
Ranbaxy Receives Final FDA Approval to Manufacture and Market Valacyclovir HCl Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 1 Feb 2007
Cardinal Health Complies With New FDA Glove Rule Two Years Ahead of Deadline
Devices
 HSMN NewsFeed - 1 Feb 2007
Aastrom Receives Orphan Drug Designation from FDA for Dilated Cardiomyopathy
Regenerative Medicine Cardiology FDA
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