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

Healthcare News Roundup: FDA

HSMN NewsFeed - 3 Sep 2013
CSL Behring Announces FDA Approval of a 10 g (50 mL) Vial Size for Hizentra(R)
Biopharmaceuticals FDA

HSMN NewsFeed - 30 Aug 2013
Philips launches new EPIQ premium ultrasound system with first-of-its-kind nSIGHT technology and Anatomical Intelligence, to address complicated imaging needs of an aging global population
Devices FDA Product Launch

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 - 28 Aug 2013
Auxilium Receives Notification of XIAFLEX(R) PDUFA Extension
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Aug 2013
BD ProbeTec(TM) Trichomonas vaginalis Q(x) Assay Launches on the BD Viper(TM) System with XTR(TM) Technology in the United States
Diagnostics FDA Product Launch

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
Tissue Regeneration Systems Receives 510(k) Approval
Devices Neurosurgery 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 - 21 Aug 2013
Elekta's Versa HD System Now Features Automated Breath Hold Gating for Improved Breast and Lung Radiotherapy
Devices Oncology FDA Product Launch

HSMN NewsFeed - 20 Aug 2013
Par Pharmaceutical Receives Approval of sANDA for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg
Biopharmaceuticals Generics FDA

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 - 16 Aug 2013
Additional GlaxoSmithKline quadrivalent intramuscular influenza vaccine approved by FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Aug 2013
Cardica Submits MicroCutter XCHANGE(TM) 30 510(k) Application For Marketing Clearance
Devices Surgery FDA

HSMN NewsFeed - 15 Aug 2013
St. Jude Medical Announces Approval and First Use of MediGuide Enabled Ablation Catheters
Devices Cardiology FDA

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 - 26 Jul 2013
Ligand Receives Orphan Designation for Captisol-Enabled(TM) Topiramate Injection
Biopharmaceuticals Neurology 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
Boston Scientific Launches OptiCross(TM) Coronary Imaging Catheter in U.S., Europe and Japan
Devices Interventional Cardiology FDA Product Launch

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 - 17 Jul 2013
La Jolla Pharmaceutical Company Receives Orphan Designation From FDA
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 16 Jul 2013
Bacterin’s OsteoSelect(R) DBM Putty Approved for Spinal Fusion Applications
Devices Orthopardic Neurosurgery FDA

HSMN NewsFeed - 12 Jul 2013
Boston Scientific Launches Guidezilla(TM) Guide Extension Catheter in U.S. and Europe
Devices Interventional Cardiology FDA Product Launch

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

Older FDA stories Return to NewsFeed

FindReps - screen and connect with rep candidates anonymously, in real time.

FindReps: Screen and connect with Medical Sales Rep candidates (Direct Reps and Independents) – anonymously, in real time.

RepJobs - Job Opportunities for Direct Sales Reps and New Product Lines for Independents!

RepJobs: Job Opportunities for Direct Sales Reps and New Product Lines for Independents!