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

Healthcare News Roundup: FDA

HSMN NewsFeed - 28 Aug 2013
LDR Receives First FDA Approval for Two-Level Cervical Disc Replacement
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 28 Aug 2013
FDA Accepts Boehringer Ingelheim's Supplemental New Drug Application for Use of Dabigatran Etexilate Mesylate in Deep Vein Thrombosis and Pulmonary Embolism
Biopharmaceuticals FDA

HSMN NewsFeed - 26 Aug 2013
Galderma Receives FDA Approval of Mirvaso(R): the First and Only FDA-Approved Topical Treatment Specifically Developed and Indicated for the Facial Erythema of Rosacea
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 26 Aug 2013
Ceptaris Receives FDA Approval for VALCHLOR(TM) (mechlorethamine) Gel for the Treatment of Stage IA and IB Mycosis Fungoides-Type Cutaneous T-Cell Lymphoma in Patients Who Have Received Prior Skin-Directed Therapy
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 23 Aug 2013
Zimmer Receives FDA Clearance For Patient Specific Instruments (PSI) Shoulder
Devices Orthopaedic Personalized Medicine FDA

HSMN NewsFeed - 21 Aug 2013
Novo Nordisk receives U.S. FDA clearance for the insulin injection device NovoPen Echo(R)
Biopharmaceuticals Devices Drug Delivery FDA

HSMN NewsFeed - 21 Aug 2013
Boston Scientific Receives FDA Approval For IntellaTip MiFi(TM) XP Ablation Catheter And 510(k) Clearance Of Zurpaz(TM) 8.5F Steerable Sheath
Devices Cardiology FDA

HSMN NewsFeed - 21 Aug 2013
Reverse Medical Corporation Announces FDA 510k Clearance of the MVP(TM) Micro Vascular Plug for Peripheral Embolization
Devices Interventional FDA Product Launch

HSMN NewsFeed - 21 Aug 2013
Tensys' TL-300 Receives SFDA Approval for Chinese Market
Devices Monitoring Regulatory

HSMN NewsFeed - 20 Aug 2013
AngioDynamics Earns FDA Clearance for Ports With BioFlo Technology to Reduce Catheter-Related Thrombus
Devices FDA

HSMN NewsFeed - 19 Aug 2013
CoAlign Innovations, Inc. Announces FDA Clearance of AccuLIF(R) Expandable Interbody Device Product Line for Lateral Surgical Approaches
Devices Neurosurgery Orthopaedic FDA

HSMN NewsFeed - 19 Aug 2013
Supernus Announces Final FDA Approval and Upcoming Launch of Trokendi XR(TM)
Biopharmaceuticals Neurology FDA Product Launch

HSMN NewsFeed - 15 Aug 2013
Ortho Kinematics Receives FDA 510(k) Clearance to Expand into Cervical Spine
Devices Orthopaedic FDA

HSMN NewsFeed - 13 Aug 2013
Quantel's Solutis Granted FDA Clearance
Devices Ophthalmology FDA

HSMN NewsFeed - 13 Aug 2013
Given Imaging Receives FDA Clearance for Next Generation PillCam(R) SB 3
Devices Gastroenterology FDA

HSMN NewsFeed - 8 Aug 2013
LDR Receives FDA Approval for the Mobi-C Cervical Disc for One-Level Use
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 8 Aug 2013
FDA Grants Orphan Drug Status To Eisai's Investigational Compound (E7777) For Cutaneous T-Cell Lymphoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 6 Aug 2013
Dallen Medical Receives FDA 510(k) Clearance for a Polymer Coated Compressyn(TM) Band
Devices Surgery FDA

HSMN NewsFeed - 31 Jul 2013
Oncos Therapeutics Granted Orphan Drug Designation for CGTG-102 in Soft Tissue Sarcoma (STS) by FDA and EMA
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 31 Jul 2013
Integra LifeSciences Receives FDA Clearance for Titan(TM) Reverse Shoulder System
Devices Orthopaedic FDA

HSMN NewsFeed - 25 Jul 2013
Abbott Receives FDA Clearance for FreeStyle Precision Pro Blood Glucose and Beta-Ketone Monitoring System(TM)
Devices Endocrinology Monitoring FDA

HSMN NewsFeed - 25 Jul 2013
Boston Scientific Receives FDA 510(k) Clearance for the Rhythmia(TM) Mapping System
Devices Cardiology FDA

HSMN NewsFeed - 24 Jul 2013
Verastem Receives Orphan Drug Designation from the U.S. FDA for Defactinib in Mesothelioma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 24 Jul 2013
FDA Grants Diazyme 510(k) Clearance to Market Its Myoglobin Assay for Clinical Chemistry Analyzers
Diagnostics Cardiology FDA

HSMN NewsFeed - 23 Jul 2013
TYRX Receives FDA Clearance for AIGISRx(R) Neuro Antibacterial Envelope
Devices Neurosurgery FDA

HSMN NewsFeed - 23 Jul 2013
Dallen Medical Files 510(k) for FDA Clearance on Tensyn(TM) Band for Syndemosis Repair
Devices Orthopaedic FDA

HSMN NewsFeed - 10 Jul 2013
CryoLife Receives FDA Premarket Approval (PMA) for New Sologrip Minimally Invasive TMR Laser Fiber-Optic Delivery System
Devices Cardiology FDA

HSMN NewsFeed - 9 Jul 2013
TYRX Receives FDA Clearance for Fully Resorbable AIGISRx(R) R Antibacterial Envelope
Devices Surgery Cardiology FDA

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