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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 - 20 Feb 2012
FDA Clears ASI’s GenASIs Advanced Imaging for HER-2/neu Analysis
Diagnostics Oncology FDA
 HSMN NewsFeed - 15 Feb 2012
BioSante Pharmaceuticals Announces FDA Approval for Bio-T-Gel™
Biopharmaceuticals FDA
 HSMN NewsFeed - 15 Feb 2012
FDA Accepts Pfizer’s New Drug Application for Tafamidis Meglumine, a Novel, Investigational Treatment for Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP)
Biopharmaceuticals Neurology
 HSMN NewsFeed - 15 Feb 2012
FDA Approves Gen-Probe's PROGENSA(R) PCA3 Assay, First Urine-Based Molecular Test to Help Determine Need for Repeat Prostate Biopsies
Diagnostics FDA
 HSMN NewsFeed - 15 Feb 2012
Santarus Announces FDA Acceptance of UCERIS New Drug Application for Induction of Remission of Active Ulcerative Colitis
Biopharmaceuticals Gastroenterology
 HSMN NewsFeed - 14 Feb 2012
AngioDynamics Receives FDA Clearance for NeverTouch Direct(TM) Procedure Kit to be Used With the VenaCure EVLT(R) System
Devices FDA
 HSMN NewsFeed - 13 Feb 2012
Medasys Inc. Announces FDA Approval for Implantable Programmable Drug Pump
Devices FDA Drug Delivery
 HSMN NewsFeed - 9 Feb 2012
Mobius Therapeutics(TM) Receives Final FDA Approval for New Glaucoma Drug
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 7 Feb 2012
Wright Medical Group, Inc. Announces 510(k) Clearance and Limited U.S. Launch of the PROPHECY(R) INBONE(R) Pre-Operative Navigation Alignment Guides
Devices Orthopaedic FDA
 HSMN NewsFeed - 6 Feb 2012
MindChild Medical, Inc. Announces Filing of a 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for the MERIDIANTM Line of Non-Invasive Fetal Heart Rate Monitors
Devices Monitoring Cardiology FDA
 HSMN NewsFeed - 1 Feb 2012
TearScience Achieves FDA Clearance for Second Generation LipiFlow(R) Thermal Pulsation System
Devices Ophthalmology FDA
 HSMN NewsFeed - 1 Feb 2012
Toshiba’s Aquilion PRIME CT System Receives FDA Clearance
Devices Radiology FDA
 HSMN NewsFeed - 1 Feb 2012
FDA approves Novartis drug Gleevec(R) label recommending extending treatment to three years for certain GIST patients after surgery
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 Jan 2012
Curis Announces FDA Approval of Erivedge(TM) (vismodegib) Capsule as First Treatment for Advanced Basal Cell Carcinoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 Jan 2012
Baxter Announces FDA Approval of Expanded Indication for TISSEEL [Fibrin Sealant] for General Hemostasis in Surgery
Devices Surgery FDA
 HSMN NewsFeed - 30 Jan 2012
Medtronic Announces FDA Approval of DF4 High-Voltage Connector System for Implantable Cardioverter Defibrillator and Cardiac Resynchronization Therapy Devices
Devices Cardiology FDA
 HSMN NewsFeed - 30 Jan 2012
Cynosure Receives FDA 510(k) Clearance for Cellulaze Cellulite Laser Workstation
Devices Dermatology FDA
 HSMN NewsFeed - 30 Jan 2012
Cytori Receives Approval From FDA to Initiate U.S. Cardiac Cell Therapy Trial; Investigational Device Exemption (IDE) Approved for ATHENA
Regenerative Medicine Cardiology
 HSMN NewsFeed - 27 Jan 2012
U.S. Food And Drug Administration Approves Pfizer’s INLYTA(R) (axitinib) For Patients With Previously Treated Advanced Renal Cell Carcinoma (RCC)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 27 Jan 2012
Pfizer Announces FDA Acceptance Of New Drug Application For Bosutinib For Patients With Previously Treated Ph+ Chronic Myeloid Leukemia
Biopharmaceuticals Oncology
 HSMN NewsFeed - 26 Jan 2012
Elite Pharmaceuticals Announces FDA Approval of Supplemental Application for Hydromorphone
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Jan 2012
LEO Pharma Announces That Picato(R) (ingenol mebutate) gel has Been Approved by US FDA for Once-Daily, 2 or 3 day Treatment of Actinic Keratoses
Biopharmaceuticals Dermatology
 HSMN NewsFeed - 25 Jan 2012
New FDA Approved Labeling For VYTORIN(R) (Ezetimibe/Simvastatin) Includes Results From the Study of Heart and Renal Protection (SHARP) in Patients With Moderate to Severe Chronic Kidney Disease
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 25 Jan 2012
FDA Approves Picato(R) (ingenol mebutate) Gel, the First and Only Topical Actinic Keratosis (AK) Therapy With 2 or 3 Consecutive Days of Once-Daily Dosing
Biopharmaceuticals Drug Delivery Dermatology FDA
 HSMN NewsFeed - 23 Jan 2012
Medtronic Announces 510(k) Clearance for the Aquamantys SBS 5.0 Sheathed Bipolar Sealer for Spine Surgery
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 23 Jan 2012
EpiCept Corporation Receives Finalized FDA Guidance for AmiKet(TM) Phase III CIPN Program and Regulatory Strategy
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Jan 2012
Guided Therapeutics Provides Update on PMA Application for LuViva(R) Advanced Cervical Scan and Timing for Filing of CE Mark
Devices Diagnostics Oncology FDA Regulatory
 HSMN NewsFeed - 20 Jan 2012
Quest Diagnostics STRATIFY JCV(TM) First FDA Market Authorized Antibody-based Blood Test to Help Stratify PML Risk in Multiple Sclerosis Patients
Diagnostics Neurology Personalized Medicine FDA
 HSMN NewsFeed - 19 Jan 2012
Gore Receives First FDA Approval for Endovascular Repair of Traumatic Aortic Transections
Devices FDA
 HSMN NewsFeed - 18 Jan 2012
FDA Grants 510(k) Clearance to Curos(R) Disinfecting Port Protector
Devices FDA
 HSMN NewsFeed - 13 Jan 2012
Torax Medical’s LINX(R) Reflux Management System Receives Unanimous Recommendation From FDA Advisory Panel
Devices Gastroenterology
 HSMN NewsFeed - 12 Jan 2012
Biomet Receives FDA Clearance for Two New Products: E1(R) Humeral Bearing for the Comprehensive(R) Reverse Shoulder System and the Comprehensive(R) Segmental Revision System
Devices Orthopaedic FDA
 HSMN NewsFeed - 12 Jan 2012
Biosense Webster Announces FDA approval of the THERMOCOOL(R) SF Catheter in the United States
Devices Cardiology FDA
 HSMN NewsFeed - 10 Jan 2012
Ortho Kinematics Receives FDA 510(k) Clearance for KineGraph VMA System
Devices Radiology Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 9 Jan 2012
Progel(R) Extended Tip Receives FDA Approval
Devices FDA
 HSMN NewsFeed - 9 Jan 2012
FDA Clears Apollo Endosurgery's SuMO(TM) Endoscopic Tissue Access and Resection System
Devices Gastroenterology FDA
 HSMN NewsFeed - 6 Jan 2012
China Kanghui Holdings Receives FDA Approvals for Hip and Knee Systems
Devices Orthopaedic FDA
 HSMN NewsFeed - 6 Jan 2012
FDA Clears PICO* Single Use Negative Pressure Wound Therapy System From Smith & Nephew, Expanding Patient Access
Devices Wound Care FDA
 HSMN NewsFeed - 5 Jan 2012
NinePoint Medical Receives FDA 510(k) Clearance for Nvision VLE Imaging System
Devices FDA
 HSMN NewsFeed - 5 Jan 2012
INSYS Therapeutics Announces FDA Approval of SUBSYS(R) Fentanyl Sublingual Spray
Biopharmaceuticals FDA
 HSMN NewsFeed - 4 Jan 2012
Amsterdam Molecular Therapeutics Receives US Orphan Designation for Hemophilia B Gene Therapy
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Jan 2012
CSL Behring Receives FDA Approval of Expanded Label on Berinert(R) for Self-administration and Treatment of Acute Laryngeal Attacks of Hereditary Angioedema
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 3 Jan 2012
Cyberonics Announces FDA Approval of Re-Designed AspireHC(TM) Generator for VNS Therapy
Devices FDA
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