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The Healthcare Sales & Marketing Network celebrates 28 years serving the medical sales & marketing community.Connecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product LinesConnecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product Lines

Healthcare News Roundup: FDA

 HSMN NewsFeed - 31 Aug 2011
Baxter Announces FDA Approval of ARTISS Fibrin Sealant for Use in Face-Lift (Facial Rhytidectomy) Procedures
Devices FDA
 HSMN NewsFeed - 30 Aug 2011
Perrigo Announces FDA Final Approval for Ketoconazole Foam, 2%
Biopharmaceuticals Generics Dermatology FDA
 HSMN NewsFeed - 30 Aug 2011
Progenics and Salix Announce FDA Acceptance of sNDA Filing for RELISTOR(R) in Patients with Non-Cancer Pain
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 Aug 2011
Spine Wave Announces FDA Clearance of the StaXx(R) XDL Expandable Device
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 29 Aug 2011
FDA Grants AirXpanders an Investigational Device Exemption to Begin Pivotal Study of an Investigational Tissue Expansion System for Women Undergoing Breast Reconstruction After Mastectomy
Devices
 HSMN NewsFeed - 29 Aug 2011
Toshiba’s New Kalare Imaging System Receives FDA Clearance
Devices Radiology FDA
 HSMN NewsFeed - 27 Aug 2011
Abbott Receives FDA Approval for ALK Gene Test for Lung Cancer Therapy Selection
Diagnostics Personalized Medicine Oncology FDA
 HSMN NewsFeed - 27 Aug 2011
U.S. Food And Drug Administration Approves Pfizer’s XALKORI(R) (crizotinib) As First And Only Therapy Specifically For Patients With Locally Advanced Or Metastatic ALK-Positive Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 26 Aug 2011
NUCYNTA(R) ER (Tapentadol Extended-Release Tablets) Receives FDA Approval for the Management of Moderate to Severe Chronic Pain
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Aug 2011
Medistem Submits Response to FDA Clinical Hold
Regenerative Medicine FDA
 HSMN NewsFeed - 25 Aug 2011
Avita Medical Receives FDA Approval to Initiate Study of Its ReCell(R) Spray-On-Skin(TM) for Cosmetic Indications
Devices Regenerative Medicine Dermatology FDA
 HSMN NewsFeed - 23 Aug 2011
Ellipse Technologies Announces FDA Clearance to Market the PRECICE(TM) Remote-Control Leg Limb Lengthening Device
Devices Orthopaedic FDA
 HSMN NewsFeed - 23 Aug 2011
IQuum Receives FDA 510(k) Clearance for Liat(TM) Influenza A/B Assay for Influenza Molecular Diagnostics in Approximately 20 Minutes
Diagnostics FDA
 HSMN NewsFeed - 23 Aug 2011
FDA Grants Fast Track Designation to Bayer's Investigational Compound Radium-223 Chloride for the Treatment of Castration-Resistant Prostate Cancer That Has Spread to the Bone
Biopharmaceuticals Oncology
 HSMN NewsFeed - 22 Aug 2011
FDA Clears Abbott's Genetic FISH Panel for Leukemia Patient Prognosis
Diagnostics Oncology FDA
 HSMN NewsFeed - 17 Aug 2011
FDA Approves Zelboraf (Vemurafenib) and Companion Diagnostic for BRAF Mutation-Positive Metastatic Melanoma, a Deadly Form of Skin Cancer
Biopharmaceuticals Oncology Personalized Medicine FDA
 HSMN NewsFeed - 17 Aug 2011
Allos Therapeutics Initiates Phase 3 Registration Trial of FOLOTYN(R) in Newly Diagnosed Patients with Peripheral T-Cell Lymphoma Following Treatment with a CHOP-based Regimen
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 11 Aug 2011
IntriCon Receives FDA 510(k) Marketing Clearance for Centauri Cardiac Diagnostic Monitor
Devices Monitoring Cardiology FDA
 HSMN NewsFeed - 9 Aug 2011
MedShape Solutions Announces FDA 510(k) Clearance of Innovative Ankle Fusion Device
Devices Orthopaedic FDA
 HSMN NewsFeed - 8 Aug 2011
Relievant Medsystems Receives FDA Approval to Begin Pivotal Study to Evaluate the Intracept System for Minimally Invasive Treatment of Chronic Low Back Pain
Devices FDA
 HSMN NewsFeed - 8 Aug 2011
Toshiba’s Patient Friendly 3T MR System Receives FDA Clearance
Devices Radiology FDA
 HSMN NewsFeed - 2 Aug 2011
Cardium Provides Update on Excellagen 510(K) Registration and Commercialization Plans
Devices Wound Care FDA
 HSMN NewsFeed - 1 Aug 2011
Derma Sciences Receives FDA Clearance for MEDIHONEY(R) Hydrogel
Devices Wound Care FDA
 HSMN NewsFeed - 1 Aug 2011
Medtronic Receives FDA Approval for Advisa DR MRI(TM) SureScan(R) Pacing System Clinical Trial
Devices Cardiology Radiology FDA
 HSMN NewsFeed - 29 Jul 2011
U.S. FDA Provides Response to Perampanel New Drug Application
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 26 Jul 2011
Diffusion Pharmaceuticals Receives FDA Orphan Status for TSC, a First-in-Class Drug for the Treatment of Primary Brain Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 25 Jul 2011
Baxter Announces FDA Approval of Subcutaneous Route of Administration for GAMMAGARD LIQUID for Patients with Primary Immunodeficiency
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Jul 2011
Merz Aesthetics Announces FDA Approval Of XEOMIN(R) (incobotulinumtoxinA) For The Temporary Improvement In The Appearance Of Moderate To Severe Glabellar Lines In Adult Patients
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 20 Jul 2011
Carticept Medical(TM) Receives 510(k) Clearance for Navigator(TM) Delivery System
Devices Drug Delivery FDA
 HSMN NewsFeed - 13 Jul 2011
ActiViews, Inc. Announces FDA 510(k) Clearance of CT-Guide™ Needle Guidance System for Lung Interventions
Devices Interventional FDA
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