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Healthcare News Roundup: FDA

 HSMN NewsFeed - 16 May 2011
BridgePoint Medical Announced 510(k) Clearance for an Expanded Indication to Treat Coronary Chronic Total Occlusions
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 9 May 2011
FDA Grants Orphan Drug Designation for Mithridion's MCD-386CR to Treat Progressive Supranuclear Palsy
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 6 May 2011
Solta Medical Announces FDA 510(k) Clearance for New Clear + Brilliant Technology
Devices Dermatology FDA
 HSMN NewsFeed - 4 May 2011
Sectra Receives FDA Clearance FOR MicroDose Mammography Modality
Devices Radiology Oncology FDA
 HSMN NewsFeed - 3 May 2011
Nihon Kohden America’s New Patient Monitoring Technology Reduces False Alarms by Greater Than 80%
Devices Monitoring FDA
 HSMN NewsFeed - 2 May 2011
Medtronic Announces FDA Clearance and First Patient Procedure with the Achieve(TM) Mapping Catheter
Devices Cardiology FDA
 HSMN NewsFeed - 27 Apr 2011
BIOTRONIK Receives FDA Approval for Expansion of the Premium Evia Pacemaker Portfolio
Devices Cardiology FDA
 HSMN NewsFeed - 27 Apr 2011
K2M Expands Degenerative Product Offering with 510(k) Clearance for EVEREST Spinal System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 26 Apr 2011
Reverse Medical Corporation Receives US FDA 510k Clearance for the ReFlex(TM) Catheter for Distal Intracranial Access
Devices Neurology Interventional FDA
 HSMN NewsFeed - 25 Apr 2011
Boston Scientific Announces FDA Approval and U.S. Launch of ION Platinum Chromium Stent System
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 25 Apr 2011
Horizon Pharma Announces FDA Approval of DUEXIS(R) (ibuprofen/famotidine) for the Relief of the Signs and Symptoms of Rheumatoid Arthritis and Osteoarthritis and to Decrease the Risk of Developing Upper Gastrointestinal Ulcers
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Apr 2011
FDA Issues Complete Response Letter for Aricept(R) Patch (donepezil transdermal system)
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 20 Apr 2011
Kelyniam Receives FDA 510(k) Clearance to Market Cranial Implants
Devices Neurosurgery FDA
 HSMN NewsFeed - 20 Apr 2011
St. Jude Medical Announces FDA Approval of Trifecta Valve
Devices Cardiology FDA
 HSMN NewsFeed - 19 Apr 2011
FDA Approves Rituxan Plus a Steroid for Use in Severe Forms of Vasculitis
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Apr 2011
STAR Orthopaedics to Host Clinical Trial of FDA Approved Personalized Knee Implant
Devices Orthopaedic Personalized Medicine
 HSMN NewsFeed - 18 Apr 2011
FDA Grants Priority Review for VEGF Trap-Eye for the Treatment of Wet Age-Related Macular Degeneration
Biopharmaceuticals Ophthalmology
 HSMN NewsFeed - 15 Apr 2011
FDA Approves the NovoTTF-100A System for the Treatment of Patients With Recurrent Glioblastoma Multiforme (GBM) Brain Tumors
Devices Oncology FDA
 HSMN NewsFeed - 15 Apr 2011
FDA Approves ACTEMRA(R) (tocilizumab) for the Treatment of Systemic Juvenile Idiopathic Arthritis (SJIA)
Biopharmaceuticals FDA
 HSMN NewsFeed - 14 Apr 2011
ARTAS System Receives FDA Clearance for Ground-Breaking Technology Treating Hair Loss
Devices FDA
 HSMN NewsFeed - 14 Apr 2011
St. Jude Medical Announces Approval of ShockGuard(TM) Technology with New DecisionTx(TM) Programming for Unify and Fortify Implantable Defibrillators
Devices Cardiology FDA
 HSMN NewsFeed - 13 Apr 2011
Devon Medical Products Receives FDA 510(k) Clearance for ArterioFlow(TM) Pump that Treats Diabetic Foot, Peripheral Arterial Disorders
Devices FDA
 HSMN NewsFeed - 13 Apr 2011
Medyssey Spine Receives 510(k) Clearance for Its LP Cage(TM) Posterior Lumbar Interbody Fusion System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 12 Apr 2011
Bone Solutions Inc. plans pivotal study of OsteoCrete(TM) for spinal fusion indication following constructive pilot study results, while preparing to launch OsteoCrete(TM) as an FDA-cleared bone void filler
Devices Orthopaedic
 HSMN NewsFeed - 12 Apr 2011
Integra LifeSciences Announces FDA Clearance for New Indication for Accell Evo3(R) Demineralized Bone Matrix
Devices Orthopaedic FDA
 HSMN NewsFeed - 11 Apr 2011
SurgiVision MRI-Compatible SmartFlow Cannula Receives FDA Clearance
Devices Neurosurgery FDA
 HSMN NewsFeed - 11 Apr 2011
Hansen Medical Submits 510(k) Application With U.S. FDA for Vascular Robotic System and Catheter
Devices Interventional FDA
 HSMN NewsFeed - 11 Apr 2011
Integra LifeSciences Receives FDA Approvals for Three Spinal Fixation Devices
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 8 Apr 2011
Antares Pharma Announces FDA Acceptance of Anturol(R) NDA for Filing
Biopharmaceuticals Urology
 HSMN NewsFeed - 7 Apr 2011
Oceana Therapeutics Gets FDA Approvable Letter for Solesta(R), a Significant Treatment Option for Fecal (Bowel) Incontinence; the Only Minimally Invasive Therapy for More Severe Bowel Control Problems
Biopharmaceuticals FDA
 HSMN NewsFeed - 4 Apr 2011
Alphatec Spine Receives 510(k) Clearance for Its Solus(TM) Anterior Lumbar Interbody Fusion System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 4 Apr 2011
CryoLife Files Investigational Device Exemption (IDE) to Begin Clinical Trials for PerClot(R) in the U.S.
Devices Surgery FDA
 HSMN NewsFeed - 4 Apr 2011
St. Jude Medical Receives FDA Approval for New Bi-Directional Ablation Catheters
Devices Cardiology FDA
 HSMN NewsFeed - 4 Apr 2011
superDimension Receives FDA 510(k) Clearance for Marker Delivery Kit
Devices FDA
 HSMN NewsFeed - 4 Apr 2011
Pfizer Receives Refusal To File Letter From U.S. FDA On Tafamidis New Drug Application
Biopharmaceuticals FDA
 HSMN NewsFeed - 4 Apr 2011
Vexim, the Specialist in Minimally Invasive Anatomical Restoration of Vertebral Compression Fractures, Has Been Awarded the FDA Clearance Needed to Launch Its COHESION(R) Cement on the US Market
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 1 Apr 2011
AngioScore Launches New Longer AngioSculpt(R) Devices for Treatment of Peripheral Artery Disease
Devices Interventional FDA
 HSMN NewsFeed - 30 Mar 2011
Vexim, Specialist in Minimally Invasive Anatomical Restoration of Vertebral Compression Fractures, is Awarded FDA Certification for Its COHESION(R) Cement
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 29 Mar 2011
FDA Clears Abbott's i-STAT(R) 1 Wireless Point of Care Testing System
Devices Diagnostics FDA
 HSMN NewsFeed - 29 Mar 2011
Access Scientific Gets FDA Clearance for POWERWAND
Devices FDA
 HSMN NewsFeed - 28 Mar 2011
FDA Approves Hyperopia Application for the MEL 80 Excimer Laser from Carl Zeiss Meditec
Devices Ophthalmology FDA
 HSMN NewsFeed - 28 Mar 2011
Medtronic Announces FDA Approval of Protecta(TM) Implantable Defibrillators That Reduce Inappropriate Shocks
Devices Cardiology FDA
 HSMN NewsFeed - 25 Mar 2011
FDA Approves Zyclara(R) (imiquimod) Cream, 3.75% for the Treatment of External Genital Warts
Biopharmaceuticals FDA
 HSMN NewsFeed - 24 Mar 2011
FDA Expands Indication for ZOSTAVAX(R), Merck’s Shingles Vaccine, to Include Adults Ages 50 to 59
Biopharmaceuticals FDA
 HSMN NewsFeed - 24 Mar 2011
Medtronic Announces FDA Approval of Consulta(R) and Syncra(TM) Cardiac Resynchronization Therapy-Pacemaker (CRT-P) Systems
Devices Cardiology FDA
 HSMN NewsFeed - 24 Mar 2011
Boston Scientific Receives FDA Approval of New Clik(TM) Anchor for Precision Plus(TM) Spinal Cord Stimulator System
Devices Neurology Pain Management FDA
 HSMN NewsFeed - 24 Mar 2011
Qualitest Receives FDA Approval for Toresmide Tablets (Generic Demadex(R)) 5 mg, 10 mg, 20 mg, 100 mg, for the Treatment of Edema Associated with Congestive Heart Failure, Renal Disease, or Hepatic Disease
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 24 Mar 2011
TranS1 Inc. Announces AxiaLIF 1L+ 510(k) FDA Clearance
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 22 Mar 2011
LensAR(TM) Laser System Receives FDA Clearance for Lens Fragmentation and Anterior Capsulotomy in Cataract Surgery
Devices Ophthalmology FDA
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