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Healthcare News Roundup: FDA

 HSMN NewsFeed - 19 May 2009
Impax Receives FDA Approval for Generic Precose Tablets, 25 mg, 50 mg and 100 mg
Biopharmaceuticals Generics Endocrinology
 HSMN NewsFeed - 19 May 2009
TearLab Corporation Announces FDA 510(k) Clearance of the TearLab(tm) Osmolarity System
Diagnostics Ophthalomology FDA
 HSMN NewsFeed - 19 May 2009
Cardiva Medical, Inc. Receives FDA Clearance for the Catalyst(TM)III System, First in Class Drug Coated Vessel Closure Device
Devices Interventional FDA
 HSMN NewsFeed - 18 May 2009
Pelleve Receives FDA Clearance for the Treatment of Mild to Moderate Facial Wrinkles
Devices Dermatology FDA
 HSMN NewsFeed - 18 May 2009
BSD Receives FDA Humanitarian Use Designation for the BSD-2000 Hyperthermia System
Devices Oncology FDA
 HSMN NewsFeed - 18 May 2009
FDA Grants Approval for Use of RISPERDAL(R) CONSTA(R) as Both a Monotherapy and Adjunctive Therapy in the Maintenance Treatment of Bipolar I Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 May 2009
U.S. Naval Medical Research Center Proposed 'RESUS' Clinical Trial in Trauma Patients Remains on FDA Hold
Biopharmaceuticals FDA
 HSMN NewsFeed - 14 May 2009
Cadence Pharmaceuticals Submits Acetavance New Drug Application for the Treatment of Acute Pain and Fever
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 May 2009
UCB's CIMZIA(R) (certolizumab pegol) Approved by the U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 May 2009
FDA Approves ACTOplus met(R) XR (pioglitazone HCl and metformin HCl extended-release) Tablets for the Treatment of Type 2 Diabetes
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 13 May 2009
AZOR(R) Receives FDA Approval as First-Line Treatment for High Blood Pressure
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 May 2009
Medtronic to Seek Indication Expansion for Heart Failure Device Therapy
Devices Cardiology FDA
 HSMN NewsFeed - 12 May 2009
ATS Medical Announces FDA Clearance of the ATS Simulus Adjustable Annuloplasty Band
Devices Cardiology FDA
 HSMN NewsFeed - 11 May 2009
St. Jude Medical Announces FDA Approval of Current Plus ICD and Promote Plus CRT-D Devices to Provide Therapy for Life-Threatening Arrhythmias and Heart Failure
Devices Cardiology FDA
 HSMN NewsFeed - 11 May 2009
FDA Approves Lamictal(R) ODT(TM) Orally Disintegrating Tablets
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 11 May 2009
Eurand Announces FDA Approval of EUR-1048 (Lamictal(R) ODT(TM)), Co-Developed With GlaxoSmithKline
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 8 May 2009
Edwards Lifesciences Receives FDA Approval for New Heart Valve
Devices Cardiology FDA
 HSMN NewsFeed - 8 May 2009
Lannett Company Receives FDA Approval for Pilocarpine HCI Tablets 7.5 mg Strength
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 6 May 2009
FDA Approves New Medtronic Left Heart Lead for Cardiac Resynchronization Therapy Devices
Devices Cardiology FDA
 HSMN NewsFeed - 6 May 2009
St. Jude Medical Announces FDA Clearance and Launch of the Attune Annuloplasty Ring for Heart Valve Repair
Devices Cardiology FDA
 HSMN NewsFeed - 5 May 2009
FDA Grants Accelerated Approval of Avastin for Brain Cancer (Glioblastoma) That Has Progressed Following Prior Therapy
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 5 May 2009
Instrumentation Laboratory Launches ACL AcuStar(TM) Hemostasis Testing System
Diagnostics FDA
 HSMN NewsFeed - 5 May 2009
Pervasis Therapeutics Granted Orphan Drug Designation for Vascugel
Biopharmaceuticals Regenerative Medicine FDA
 HSMN NewsFeed - 5 May 2009
Novagali Pharma Announces FDA Clearance of IND for Phase III of Catioprost(R), its Cationic Emulsion of Latanoprost in Patients With Glaucoma
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 5 May 2009
AdvanDx Receives FDA 510(k) Clearance for EK/P. aeruginosa PNA FISH(R)
Diagnostics FDA
 HSMN NewsFeed - 5 May 2009
Spectranetics Makes Pre-IDE Submission to FDA for the Treatment of In-Stent Restenosis in the Legs
Devices Interventional
 HSMN NewsFeed - 4 May 2009
X-spine Announces New FDA Clearance of Spinal Implant System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 4 May 2009
Gore Receives FDA Clearance for GORE BIO-A Fistula Plug
Devices FDA
 HSMN NewsFeed - 4 May 2009
CoreSpine Technologies(TM) Receives Clearance to Market Surgical Disc Preparation Device
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 4 May 2009
Morph AccessPro Receives FDA Clearance
Devices Interventional FDA
 HSMN NewsFeed - 1 May 2009
Excelsior Medical Corporation Receives FDA Approval to Market SwabCap(TM) Luer Access Valve Disinfection Cap
Devices FDA
 HSMN NewsFeed - 30 Apr 2009
Positron Joint Venture Receives FDA Approval for Attrius(TM) Scanner Product Line
Devices Radiology FDA
 HSMN NewsFeed - 30 Apr 2009
FDA Approves Dysport(TM) for Therapeutic and Aesthetic Uses
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 Apr 2009
MMDI's Rebound HRD(R) V Receives FDA 510(k) Clearance
Devices Surgery FDA
 HSMN NewsFeed - 29 Apr 2009
FDA Grants Orphan Drug Designation to Oncophage for the Treatment of Glioma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 28 Apr 2009
XIAFLEX(TM) for the Treatment of Dupuytren's Contracture Receives Priority Review From the U.S. Food and Drug Administration
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Apr 2009
FDA has Granted HUD (Humanitarian Use Device) Designation to ITGI's Pericardium Covered Stents, Over and Under(R) and Aneugraft(R), for Treatment of Perforations and Dissections of Native Coronary Arteries and Saphenous Vein Grafts
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 28 Apr 2009
ISTO Technologies, Inc. Announces FDA Approval to Initiate a Clinical Trial for a Novel Treatment for Disc Nucleus Regeneration
Devices Orthopaedic Regenerative Medicine FDA
 HSMN NewsFeed - 28 Apr 2009
Power Medical Interventions(r) Files 510(k) Application With FDA for Marketing Clearance of iDrive Intelligent Power Unit(tm) and iConsole(tm) Monitor
Devices Surgery FDA
 HSMN NewsFeed - 28 Apr 2009
OncoGenex Receives Confirmation from FDA on the Design of a Second Phase 3 Trial Evaluating OGX-011 for the Treatment of Advanced Prostate Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 27 Apr 2009
Prodarsan(R) granted Orphan Drug designation from FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 24 Apr 2009
SIMPONI(TM) (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Apr 2009
U.S. Food and Drug Administration Extends Review Timeline for ONGLYZA (saxagliptin) New Drug Application
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 23 Apr 2009
Revolutions Medical Acquires Exclusive Rights to License FDA Approved Breast Biopsy Localization System
Devices Oncology Licensing
 HSMN NewsFeed - 22 Apr 2009
MiMedx Group Announces FDA Clearance to Market the Parads Vaso Shield Device
Devices Orthopaedic Neurosurgery
 HSMN NewsFeed - 22 Apr 2009
Abiomed Receives FDA 510(k) Clearance for Impella 5.0 and Impella LD
Devices Cardiology FDA
 HSMN NewsFeed - 22 Apr 2009
FDA Grants Ethicon Endo-Surgery Approval of Its IDE Application to Commence Study of Notes Toolbox(TM)
Devices Surgery FDA
 HSMN NewsFeed - 22 Apr 2009
Watson Files FDA Applications for Generic Mucinex(R)
Biopharmaceuticals Generics Litigation FDA
 HSMN NewsFeed - 22 Apr 2009
Telesso Technologies Initiates Head-to-Head Study Comparing its FDA-Approved Guide Wire-Assisted Peripheral IV Catheter to the Industry's Gold Standard
Devices
 HSMN NewsFeed - 20 Apr 2009
Thoratec Announces Filing of PMA Seeking Destination Therapy Approval for HeartMate II(R)
Devices Cardiology FDA
 HSMN NewsFeed - 20 Apr 2009
Pivotal Clinical Data Published for the Only Laser Phototherapy Device Cleared by the FDA for Hair Growth
Devices
 HSMN NewsFeed - 16 Apr 2009
Somanetics Announces New FDA 510(K) Clearance
Devices Monitoring FDA
 HSMN NewsFeed - 16 Apr 2009
BIOLASE Announces FDA 510(K) Clearance of Its ezlase(TM) Diode Laser for Pain Therapy & Relief
Devices FDA
 HSMN NewsFeed - 15 Apr 2009
Merit Medical Announces 510(k) Clearance
Devices FDA
 HSMN NewsFeed - 14 Apr 2009
Oasmia: FDA Grants Paclical(r) Orphan Drug Designation for Ovarian Cancer in the USA
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 9 Apr 2009
NMT Medical Receives PMA Approval for STARFlex as a Ventricular Septal Defect Repair Implant
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 8 Apr 2009
Core Essence Receives FDA Approval for SECURUS(TM), an Innovative Knotless Suture Anchor System
Devices Orthopaedic Surgery FDA
 HSMN NewsFeed - 7 Apr 2009
FDA Approves Label Change for Non-Invasive Fibroid Treatment
Devices FDA
 HSMN NewsFeed - 7 Apr 2009
IntelGenx Corp. and Cary Pharmaceuticals File NDA for CPI-300 Antidepressant
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Apr 2009
Vasomedical Introduces BIOX Holter Monitoring Systems and Analysis Software
Devices Monitoring FDA
 HSMN NewsFeed - 6 Apr 2009
Bioject Announces FDA Market Clearance for the Zetajet Needle-Free Injection Therapy System
Devices Drug Delivery FDA
 HSMN NewsFeed - 3 Apr 2009
Berlin Heart Receives First Regulatory Approval in North America
Devices Cardiology FDA
 HSMN NewsFeed - 2 Apr 2009
Update on FDA Advisory Committee Meeting on Liraglutide for the Treatment of Type 2 Diabetes
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 2 Apr 2009
LDR Announces FDA Clearance of Its ROI-A ALIF Device
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 2 Apr 2009
Xanodyne's New Drug Application for the Treatment of Heavy Menstrual Bleeding (Menorrhagia) Accepted for Filing with a Priority Review Classification
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Apr 2009
Orthovita Submits Additional Data to FDA in Support of Its 510(k) Application for the Use of CORTOSS Bone Augmentation Material in Vertebral Augmentation
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 1 Apr 2009
Teva Announces Approval of Generic Yaz Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 31 Mar 2009
Invatec Introduces AMPHIRION DEEP Long Balloon to More Easily Access and Treat Arteries Below the Knee
Devices Interventional FDA
 HSMN NewsFeed - 30 Mar 2009
Mylan's Matrix Receives First Tentative FDA Approval Under PEPFAR for Generic Truvada(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 30 Mar 2009
Inverness Medical Innovations Launches New FDA Cleared C. DIFF QUIK CHEK COMPLETE(TM) Rapid Test
Diagnostics
 HSMN NewsFeed - 30 Mar 2009
Seattle Genetics Receives FDA Fast Track Designation for SGN-35 for the Treatment of Hodgkin Lymphoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 Mar 2009
FDA Approves Abiomed's New AB Portable Driver; Providing Patient Transport, Mobility and Ambulation without Compromising Performance
Devices FDA Cardiology
 HSMN NewsFeed - 27 Mar 2009
Teva Announces Approval and Launch of Generic Topamax Tablets
Biopharmaceuticals Neurology FDA Generics
 HSMN NewsFeed - 27 Mar 2009
Zydus Pharmaceuticals (USA) Inc. Announces FDA Final Approval for the Generic Version of Topamax(R) Tablets
Biopharmaceuticals Neurology FDA Generics
 HSMN NewsFeed - 27 Mar 2009
AtriCure's Cryoablation System, Cryo1, Receives FDA 510(k) Clearance
Devices Cardiology FDA
 HSMN NewsFeed - 27 Mar 2009
FDA Classifies Medtronic Voluntary February Recall for BioGlide Ventricular Snap Shunt Catheters (Models 27782, 27708 and 27802) as Class I
Devices Neurosurgery Product Recall
 HSMN NewsFeed - 26 Mar 2009
Physio-Control Receives FDA 510(k) Clearance for LIFEPAK 15 Monitor/Defibrillator
Devices Monitoring FDA
 HSMN NewsFeed - 26 Mar 2009
Sagent Pharmaceuticals Announces U.S. FDA Approval of Azithromycin for Injection
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Mar 2009
Digirad Receives 510(k) for Cardius X-ACT Rapid Cardiac SPECT/VCT Imager
Devices Radiology Cardiology FDA
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