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Healthcare News Roundup: FDA

 HSMN NewsFeed - 24 Dec 2013
Atossa Genetics Submits Premarket 510(k) Notification for ForeCYTE Breast Aspirator
Devices Diagnostics Oncology FDA
 HSMN NewsFeed - 24 Dec 2013
Veloxis Pharmaceuticals Envarsus(R) Granted Orphan Drug Status by U.S. Food and Drug Administration for Kidney Transplant Rejection Prophylaxis
Biopharmacecuticals FDA
 HSMN NewsFeed - 20 Dec 2013
Endologix Receives IDE Approval for the Nellix(R) EndoVascular Aneurysm Sealing System
Devices Interventional FDA
 HSMN NewsFeed - 20 Dec 2013
Cellceutix Files Orphan Drug Designation Application for Brilacidin for Oral Mucositis with US FDA
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 20 Dec 2013
Solana Surgical Receives FDA Clearance for the CrossCHECK Plating System
Devices Orthopaedic FDA
 HSMN NewsFeed - 19 Dec 2013
Baxter Receives FDA Approval of FEIBA [Anti-Inhibitor Coagulant Complex] for Prophylactic Treatment of Hemophilia A&B Patients with Inhibitors
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Dec 2013
Regeneron Announces FDA Acceptance of EYLEA(R) (aflibercept) Injection Supplemental Biologics License Application for Review for Diabetic Macular Edema Indication
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 18 Dec 2013
Oticon Medical Receives FDA Clearance to Market New Ponto Plus Bone Anchored Sound Processors in Regular and Power Versions
Devices FDA
 HSMN NewsFeed - 11 Dec 2013
Ethicon Receives 510(k) Clearance for New HARMONIC FOCUS(R)+ Shears with Adaptive Tissue Technology
Devices Surgery FDA
 HSMN NewsFeed - 11 Dec 2013
FDA Grants Priority Review for Genzyme’s Cerdelga(TM) (eliglustat), an Investigational Oral Therapy for Gaucher Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 Dec 2013
FDA Grants Fast Track Designation to Navidea Biopharmaceuticals’ Lymphoseek(R) for Sentinel Lymph Node Detection in Patients with Head and Neck Cancer
Diagnostics Oncology FDA
 HSMN NewsFeed - 10 Dec 2013
Reverse Medical(R) Corporation Announces FDA 510k Clearance of the MVP(R)-5 Micro Vascular Plug for Peripheral Embolization
Devices Interventional FDA
 HSMN NewsFeed - 9 Dec 2013
FDA Advisory Committee Recommends Approval of Takeda's Investigational Biologic Vedolizumab
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 9 Dec 2013
American Medical Systems Receives FDA 510(k) Clearance of the RetroArc(TM) Retropubic Sling System for Treatment of Female Stress Urinary Incontinence
Devices FDA
 HSMN NewsFeed - 6 Dec 2013
U.S. Food and Drug Administration Approves Gilead’s Sovaldi(TM) (Sofosbuvir) for the Treatment of Chronic Hepatitis C
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Dec 2013
Auxilium Announces U.S. Food and Drug Administration Approval for XIAFLEX(R) for the Treatment of Peyronie's Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 Dec 2013
23andMe, Inc. Provides Update on FDA Regulatory Review
Diagnostics FDA
 HSMN NewsFeed - 3 Dec 2013
Sense4Baby, Inc.(TM) receives 510(k) clearance and CE mark for commercializing smartphone-based maternal/fetal monitoring system in the U.S. and Europe
Devices Monitoring FDA Regulatory
 HSMN NewsFeed - 3 Dec 2013
Xlumena Closes Series C Financing; Focuses on Expanding Global Commercial Presence and Obtaining FDA Clearance
Devices Interventional Gastroenterology Venture Capital
 HSMN NewsFeed - 2 Dec 2013
Claret Medical Announces Filing Of US Pivotal IDE Application For The Sentinel(TM) Cerebral Protection System
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 29 Nov 2013
Sumitomo Proton Therapy System Clears FDA 510(k)
Devices Oncology FDA
 HSMN NewsFeed - 27 Nov 2013
Elekta Receives US FDA 510(k) Clearance for its Monaco 5 Treatment Planning System
Devices Oncology FDA Product Launch
 HSMN NewsFeed - 27 Nov 2013
CMC Contrast Granted Orphan Drug Designation by the FDA for its Liver Specific MRI Contrast Media CMC-001
Biopharmaceuticals Radiology FDA
 HSMN NewsFeed - 26 Nov 2013
FDA Approves Varithena(TM) (Polidocanol Injectable Foam) for the Treatment of Patients with Varicose Veins
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Nov 2013
U.S. Food and Drug Administration (FDA) Extends Review of Mallinckrodt’s New Drug Application for XARTEMIS(TM) XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII)
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Nov 2013
KCI Introduces the Next Generation V.A.C.Via(TM) Therapy System
Devices Wound Care FDA Product Launch
 HSMN NewsFeed - 21 Nov 2013
Dallen Medical Receives FDA 510(k) Clearance for Its Tensyn(TM) Band for Syndesmosis Repair
Devices Orthopaedic FDA
 HSMN NewsFeed - 21 Nov 2013
Forest Laboratories and Gedeon Richter Receive Complete Response Letter for Cariprazine
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Nov 2013
TauTona Group Receives FDA 510(k) Clearance and Key Patent for 'TauTona Tissue Injector'
Devices FDA
 HSMN NewsFeed - 19 Nov 2013
FDA Clears New Plasma Protocol Software for Fenwal Alyx(R) System
Devices FDA
 HSMN NewsFeed - 19 Nov 2013
AtriCure Receives FDA Approval for Investigational Study to Evaluate Stroke Prevention in Atrial Fibrillation
Devices Cardiology FDA
 HSMN NewsFeed - 18 Nov 2013
Merck’s New Drug Application for an Investigational Intravenous (IV) Formulation of NOXAFIL(R) (posaconazole) Receives FDA Priority Review
Biopharmaceuticals FDA Regulatory
 HSMN NewsFeed - 18 Nov 2013
Actinium Pharmaceuticals Announces Plans For Iomab(TM)-B Phase 3 Pivotal Trial Following Meeting With FDA
Biopharmaceuticals
 HSMN NewsFeed - 15 Nov 2013
Valeant Pharmaceuticals Announces U.S. Approval Of Luzu(R) Cream, 1%
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 15 Nov 2013
Lumenis Receives US FDA and Japanese MHLW Clearance for Array(TM) LaserLink(TM) Pattern Scanning Device for Multi-Spot Retinal Laser Treatment
Devices Ophthalmology FDA Regulatory
 HSMN NewsFeed - 7 Nov 2013
EndoShape Receives 510(k) Clearance for Polymer Embolization Device
Devices Interventional FDA
 HSMN NewsFeed - 7 Nov 2013
FDA Clears Fish-Skin Technology to Heal Human Wounds
Devices Wound Care FDA
 HSMN NewsFeed - 7 Nov 2013
BioCer Announces CE Approval for Mastectomy "Bra" plus FDA Approval for Hernia repair system TiO2Mesh(TM)
Devices Regulatory
 HSMN NewsFeed - 6 Nov 2013
Gore Receives FDA Approval for 25 cm GORE(R) VIABAHN(R) Endoprosthesis
Devices Interventional FDA
 HSMN NewsFeed - 5 Nov 2013
First and Only FDA-Approved, Non-Hormonal Treatment for Moderate to Severe Hot Flashes Now Available by Prescription in U.S. Pharmacies
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 Nov 2013
OrSense Receives FDA Clearance for Its Noninvasive Hemoglobin Monitor
Devices Monitoring FDA
 HSMN NewsFeed - 1 Nov 2013
FDA Approves Gazyva (Obinutuzumab) for People With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 31 Oct 2013
Stem Cell Therapeutics Receives U.S. Orphan Drug Designation for the Use of Tigecycline to Treat Acute Myeloid Leukemia
Regenerative Medicine Oncology FDA
 HSMN NewsFeed - 30 Oct 2013
NLT SPINE’s PROW FUSION(TM) and eSPIN(TM) Receive 510(k) Clearance
Devices Neurosurgery Orthopaedic FDA
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