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Healthcare News Roundup: FDA

 HSMN NewsFeed - 7 Aug 2012
Abbott's Omnilink Elite(R) Vascular Balloon-Expandable Stent System Receives FDA Approval for Treatment of Iliac Artery Disease
Devices Interventional FDA
 HSMN NewsFeed - 7 Aug 2012
Toshiba Receives FDA Clearance for the Industry’s First 16-Element MR Flex Coils
Devices Radiology FDA
 HSMN NewsFeed - 6 Aug 2012
Bausch & Lomb and Technolas(TM) Perfect Vision Receive 510(k) FDA Clearance from FDA for VICTUS(TM) Femtosecond Laser Platform
Devices Ophthalmology FDA
 HSMN NewsFeed - 6 Aug 2012
Sunshine Heart Announces Conditional Approval From FDA for Its Next Generation C-Pulse(R) System Driver
Devices Cardiology FDA
 HSMN NewsFeed - 30 Jul 2012
23andMe Takes First Step Toward FDA Clearance
Diagnostics Personalized Medicine FDA
 HSMN NewsFeed - 30 Jul 2012
Covidien Announces FDA 510(k) Clearance of the Nellcor(TM) Bedside SpO2 Patient Monitoring System
Devices Monitoring FDA
 HSMN NewsFeed - 26 Jul 2012
FDA Advisory Committee Unanimously Recommends Approval of Lucentis for Treatment of Diabetic Macular Edema (DME)
Biopharmaceuticals Ophthalmology Endocrinology FDA
 HSMN NewsFeed - 25 Jul 2012
FDA Clears First Robotic-Assisted System for Coronary Artery Disease Stent Procedures
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 25 Jul 2012
Guided Therapeutics and FDA Agree on Plan for LuViva(R) Advanced Cervical Scan PMA
Devices Diagnostics Oncology FDA
 HSMN NewsFeed - 24 Jul 2012
Siemens MAGNETOM Spectra 3T MRI System Receives FDA Clearance
Devices Radiology FDA
 HSMN NewsFeed - 20 Jul 2012
Onyx Pharmaceuticals Receives FDA Accelerated Approval of Kyprolis(TM) (carfilzomib) for Injection
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 18 Jul 2012
FDA Clears First Ever Bi-directionally Retrievable Vena Cava Filter from Crux Biomedical
Devices Interventional FDA
 HSMN NewsFeed - 16 Jul 2012
TriReme Receives FDA Approval for Expanded Matrix of Novel Glider(TM) PTCA Balloon Catheter
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 12 Jul 2012
Kimberly-Clark Health Care Receives FDA Clearance For KIMGUARD ONE-STEP Sterilization Wrap Portfolio With One-Year Maintenance Of Package Integrity And Amsco V-PRO maX (Flexible Cycle)
Devices FDA
 HSMN NewsFeed - 11 Jul 2012
Asthmapolis Receives FDA Clearance for Asthma Inhaler Sensor Technology and Accompanying Software System
Devices FDA
 HSMN NewsFeed - 10 Jul 2012
Next Generation of myoscience Device Receives FDA Clearance for Pain Management
Devices FDA
 HSMN NewsFeed - 10 Jul 2012
Human Genome Sciences Announces Resubmission of Raxibacumab BLA to FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 9 Jul 2012
FDA Clears Cook Medical’s Evolution(R) Colonic Controlled-Release Stent
Devices Gastroenterology FDA
 HSMN NewsFeed - 9 Jul 2012
Capricor Announces FDA Approval To Initiate ALLSTAR Trial of Allogeneic Stem Cell Therapy In Patients Following Heart Attack
Regenerative Medicine Cardiology FDA
 HSMN NewsFeed - 2 Jul 2012
Edwards Intuity Valve System Cleared to Begin U.S. Trial
Devices Cardiology FDA
 HSMN NewsFeed - 2 Jul 2012
Teleflex Receives FDA 510(k) Clearance for CVP Monitoring Indication on the ArrowADVANTAGE5(TM) Pressure-Injectable PICC
Devices Monitoring FDA
 HSMN NewsFeed - 29 Jun 2012
Actelion Pharmaceuticals Announces U.S. Food and Drug Administration Approval of Supplemental New Drug Application for Second Generation VELETRI(R) (epoprostenol) for Injection
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Jun 2012
Synergetics USA Announces FDA Clearance of VersaVIT(TM) Vitrectomy System
Devices Ophthalmology FDA
 HSMN NewsFeed - 25 Jun 2012
Baxter Announces FDA Approval for GAMMAGARD LIQUID as a Treatment for Multifocal Motor Neuropathy
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 25 Jun 2012
Bristol-Myers Squibb and Pfizer Receive Complete Response Letter from U.S. Food and Drug Administration for ELIQUIS(R) (apixaban)
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 25 Jun 2012
FDA Approves enVista(TM), a Single-Piece Intraocular Lens, Made From the Glistening-Free, Hydrophobic, Acrylic Material Developed by AVS
Devices Ophthalmology FDA
 HSMN NewsFeed - 22 Jun 2012
Elekta's Agility Radiation Therapy Beam-shaping Innovation for Cancer Treatments Receives U.S. 510(k) Clearance
Devices Oncology FDA
 HSMN NewsFeed - 22 Jun 2012
FDA Advisory Panel Votes in Favor of Dune Medical Devices MarginProbe(R) System
Diagnostics Oncology FDA
 HSMN NewsFeed - 21 Jun 2012
Surefire Medical Receives FDA Clearance For High-Flow Microcatheter
Devices Interventional FDA
 HSMN NewsFeed - 21 Jun 2012
FDA Approves Lyrica For The Management Of Neuropathic Pain Associated With Spinal Cord Injury Based On Priority Review
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Jun 2012
Ampio Reports Successful Type B Pre-IND Meeting with the FDA for its Drug Zertane(TM) to treat Premature Ejaculation (PE)
Biopharmaceuticals Urology FDA
 HSMN NewsFeed - 20 Jun 2012
Bausch & Lomb Receives FDA Approval of the enVista(TM) Intraocular Lens
Devices Ophthalmology FDA
 HSMN NewsFeed - 19 Jun 2012
InTouch Health Announces New FDA 510(k) Clearance for Its Remote Presence Acute Care Telemedicine Devices
Devices Monitoring FDA
 HSMN NewsFeed - 19 Jun 2012
TriReme Medical Receives FDA Clearance for Expanded Matrix of Sizes of Chocolate PTA Balloon Catheter
Devices Interventional FDA
 HSMN NewsFeed - 18 Jun 2012
St. Jude Medical Announces FDA Clearance of the AMPLATZER Vascular Plug 4
Devices Interventional FDA
 HSMN NewsFeed - 18 Jun 2012
LensAR Laser System(TM) Receives FDA Clearance for Anterior Capsulotomy and Laser Phacofragmentation in Cataract Surgery
Devices Ophthalmology FDA
 HSMN NewsFeed - 15 Jun 2012
U.S. patients and clinics to benefit from new revolutionary beam-shaping device
Devices Oncology FDA
 HSMN NewsFeed - 13 Jun 2012
Cardiosolutions, Inc. Receives FDA 510(k) Clearance for Dexterity(TM) Steerable Introducer
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 13 Jun 2012
Stratatech’s StrataGraft(R) Skin Substitute Granted FDA Orphan Drug Designation
Devices Biopharmaceuticals Regenerative Medicine FDA
 HSMN NewsFeed - 13 Jun 2012
FDA Clears New Siemens SOMATOM Perspective CT Scanner
Devices Radiology FDA
 HSMN NewsFeed - 13 Jun 2012
OSI Systems Introduces AriaTele(TM) Telemetry Transmitter
Devices Monitoring FDA
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