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Healthcare News Roundup: FDA

 HSMN NewsFeed - 18 Feb 2014
Claret Medical Announces IDE Approval for U.S. Pivotal Trial of the Sentinel(TM) Cerebral Protection System
Devices Interventional FDA
 HSMN NewsFeed - 12 Feb 2014
DEKA Medical Receives FDA Clearance for the Synchro REPLA:Y
Devices Dermatology FDA
 HSMN NewsFeed - 11 Feb 2014
Marvao Medical Receives second FDA Clearance for its NexSite(TM) HD Catheter product line
Devices FDA
 HSMN NewsFeed - 10 Feb 2014
AliveCor Receives FDA Over-the-Counter Clearance for Its Heart Monitor
Devices Cardiology Monitoring FDA Product Launch
 HSMN NewsFeed - 6 Feb 2014
Covidien Receives U.S. FDA 510(k) Clearance for Reinforced Stapling Reload Technology
Devices Surgery FDA
 HSMN NewsFeed - 6 Feb 2014
Spectrum Pharmaceuticals Announces FDA’s Acceptance of NDA Filing for Beleodaq(TM) (belinostat) for Injection, a novel pan-HDAC inhibitor
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 4 Feb 2014
Ellipse Technologies Receives FDA Clearance for Next Generation of Unique Limb Lengthening System
Devices Orthopaedic FDA
 HSMN NewsFeed - 3 Feb 2014
Given Imaging Receives FDA Clearance for PillCam(R) COLON in Patients Following Incomplete Colonoscopy
Devices Gastroenterology FDA
 HSMN NewsFeed - 31 Jan 2014
B. Braun Receives FDA Approval For Next Generation 1L Intravenous Containers
Devices Drug Delivery FDA
 HSMN NewsFeed - 31 Jan 2014
Acella Pharmaceuticals, LLC, Announces Approval and Launch of Loutrex Topical Cream
Biopharmaceuticals Devices Dermatology FDA
 HSMN NewsFeed - 31 Jan 2014
Valeant Pharmaceuticals Announces Approval of Retin-A Micro(R) Microsphere 0.08%
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 30 Jan 2014
Ulthera(R) System Receives Third FDA Clearance
Devices Dermatology FDA
 HSMN NewsFeed - 28 Jan 2014
Teva Announces U.S. FDA Approval of Three-Times-a-Week COPAXONE(R) (glatiramer acetate injection) 40mg/mL
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 28 Jan 2014
Valiant Captivia Thoracic Stent Graft System From Medtronic Receives FDA Approval for Treating Aortic Dissections
Devices Interventional FDA
 HSMN NewsFeed - 28 Jan 2014
Kiva(R) VCF Treatment System Receives FDA Clearance For Vertebral Compression Fractures
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 27 Jan 2014
eNeura Files 510(k) with the FDA for SpringTMS(R) Migraine Treatment
Devices Neurology FDA
 HSMN NewsFeed - 24 Jan 2014
SafeSept(R) Needle Free Transseptal Guidewire Receives FDA Market Clearance
Devices Cardiology FDA
 HSMN NewsFeed - 22 Jan 2014
Medtronic SureScan(R) Pacing Systems First to Be Approved for Full Body MRI Scans Without Positioning Restrictions
Devices Cardiology Radiology FDA
 HSMN NewsFeed - 22 Jan 2014
Covidien Receives U.S. Food and Drug Administration Clearance for LigaSure(TM) Maryland Jaw
Devices Surgery FDA
 HSMN NewsFeed - 21 Jan 2014
Affymetrix Receives FDA Clearance of First-of-its-kind Postnatal Test for Developmental Delays and Intellectual Disabilities in Children
Diagnostics FDA
 HSMN NewsFeed - 17 Jan 2014
Medtronic CoreValve(R) System Obtains Early FDA Approval on Exceptional Clinical Performance
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 15 Jan 2014
Varian Medical Systems Receives FDA 510(k) Clearance for its ProBeam(TM) Proton Therapy System
Devices Oncology FDA
 HSMN NewsFeed - 13 Jan 2014
LabCorp to Offer New FDA approved Breast Cancer Prognostic Test
Diagnostics Oncology Product Launch
 HSMN NewsFeed - 13 Jan 2014
Merck Initiates Rolling Submission of U.S. Biologics License Application for MK-3475, an Investigational Anti-PD-1 Immunotherapy, in Patients with Advanced Melanoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 13 Jan 2014
U.S. FDA Approves Farxiga(TM) (Dapagliflozin) Tablets for the Treatment of Adult Patients with Type 2 Diabetes
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 9 Jan 2014
Cardica Receives 510(k) Clearance For MicroCutter XCHANGE(TM) 30 Cutting/Stapling Device
Devices Surgery FDA
 HSMN NewsFeed - 9 Jan 2014
Mylan Launches Generic Myfortic Delayed-Release Tablets
Biopharmaceuticals Generics FDA Product Launch
 HSMN NewsFeed - 8 Jan 2014
Merck Receives FDA Approval for ISENTRESS(R) (raltegravir) for Pediatric Oral Suspension
Biopharmaceuticals HIV/AIDS FDA
 HSMN NewsFeed - 8 Jan 2014
Encision Files 510(k) with FDA for AEM(R) Simplification Product
Devices Surgery FDA
 HSMN NewsFeed - 7 Jan 2014
FDA Clears IsoRay's Liquid Cesium (Cesitrex)(TM) for Use With GliaSite(R) in Treating Glioblastomas and Metastatic Brain Cancers
Devices Oncology FDA
 HSMN NewsFeed - 7 Jan 2014
Gentle, Simple SinuSys(TM) Vent-Os(TM) Sinus Dilation System Obtains FDA Clearance
Devices FDA
 HSMN NewsFeed - 6 Jan 2014
FDA Reclassifies ECP Devices for Refractory Angina as Class II
Devices Cardiology FDA
 HSMN NewsFeed - 6 Jan 2014
Peregrine Pharmaceuticals Receives FDA Fast Track Designation for Its Immunotherapy Bavituximab as a Potential Treatment of Second-Line Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 3 Jan 2014
RegeneRx Receives Orphan Drug Designation for Tβ4 in the Treatment of Neurotrophic Keratopathy
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 2 Jan 2014
Kinsa Receives First-Ever FDA Approval for Smartphone-Connected Oral Thermometer
Devices FDA
 HSMN NewsFeed - 2 Jan 2014
Smiths Medical Receives FDA 510(k) Clearance on Innovative Solution for Pain Management with CADD(R)-Solis Infusion Pump
Devices Drug Delivery FDA
 HSMN NewsFeed - 2 Jan 2014
Cell Therapeutics Announces Removal of the Partial Clinical Hold on Tosedostat
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 31 Dec 2013
Star Scientific Receives a Warning Letter From the FDA Regarding Consumer Products
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Dec 2013
Quidel Receives FDA Clearance for Its Hand-Held Molecular Diagnostic Test - AmpliVue(R) Group B Strep Assay
Diagnostics FDA
 HSMN NewsFeed - 30 Dec 2013
Stryker Receives FDA Clearance for Waste Management System
Devices Surgery FDA
 HSMN NewsFeed - 30 Dec 2013
Electromed, Inc. Receives FDA Market Clearance for the SmartVest(R) SQL(TM)
Devices FDA
 HSMN NewsFeed - 30 Dec 2013
Cubist Announces FDA Acceptance of Tedizolid New Drug Application with Priority Review
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Dec 2013
Genzyme Receives Complete Response Letter from FDA on Lemtrada(TM) (alemtuzumab) Application
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 30 Dec 2013
FDA Approves SALMONELEX(TM) Against Salmonella as New Food Processing Aid
Biopharmaceuticals FDA
 HSMN NewsFeed - 24 Dec 2013
Atossa Genetics Submits Premarket 510(k) Notification for ForeCYTE Breast Aspirator
Devices Diagnostics Oncology FDA
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