Healthcare Sales & Marketing Network: FDA : Medical Device and Pharmaceutical News

Healthcare News Roundup: 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
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 - 5 Dec 2013
23andMe, Inc. Provides Update on FDA Regulatory Review
Diagnostics FDA

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 - 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 - 21 Nov 2013
Dallen Medical Receives FDA 510(k) Clearance for Its Tensyn(TM) Band for Syndesmosis Repair
Devices Orthopaedic 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 - 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
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
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

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