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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 - 1 Oct 2012
FDA Panel Recommends FDA Approval for Second Sight’s Argus(R) II Retinal Prosthesis System
Devices Ophthalmology FDA
 HSMN NewsFeed - 1 Oct 2012
Sunshine Heart Announces Conditional Approval of IDE From the FDA for C-Pulse(R) Heart Assist System
Devices Cardiology FDA
 HSMN NewsFeed - 27 Sep 2012
Bayer's Stivarga(R) (regorafenib) Tablets Approved by U.S. FDA for Treatment of Metastatic Colorectal Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 27 Sep 2012
Amedica Receives FDA 510(k) Clearance For A Second Generation Interbody Fusion Device System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 26 Sep 2012
Bolton Medical Receives FDA Approval for the Relay(R) Thoracic Stent-Graft, a Minimally-Invasive Treatment for Thoracic Aortic Aneurysms and Penetrating Ulcers
Devices Interventional FDA
 HSMN NewsFeed - 25 Sep 2012
Precision Spine(TM) Announces FDA 510(k) Clearance for ReForm(TM) Pedicle Screw System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 24 Sep 2012
Masimo Oximeters and Neonatal Sensors Receive FDA 510(k) Clearance with Labeling for Use in Newborn Screening for Critical Congenital Heart Disease (CCHD)
Devices Monitoring FDA
 HSMN NewsFeed - 24 Sep 2012
Teleflex Receives FDA 510(k) Clearance for ARROW(R) FlexBlock(TM) Continuous Peripheral Nerve Block Catheter
Devices FDA
 HSMN NewsFeed - 20 Sep 2012
Innovative Ultrasound Company SuperSonic Imagine Receives FDA Clearance to Enhance ShearWave(TM) Elastography Imaging with a Real-Time Adjustable Numerical Scale (ANS)
Devices FDA
 HSMN NewsFeed - 18 Sep 2012
Aptus Endosystems Receives U.S. FDA Clearance For Thoracic-Length HeliFX Aortic Securement System
Devices Interventional FDA
 HSMN NewsFeed - 18 Sep 2012
Sarepta Therapeutics' Lead Therapeutic Drugs for Ebola and Marburg Viruses Receive FDA Fast Track Designation
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Sep 2012
Teleflex Receives FDA Clearance for ARROW(R) Peripherally Inserted Central Catheter (PICC) Preloaded with ARROW(R) VPS(R) Vascular Positioning System(R) Stylet
Devices FDA
 HSMN NewsFeed - 13 Sep 2012
Sorin Group Receives SFDA Approval and Announces Commercial Launch of REPLY(TM) and ESPRIT(TM) Families of Pacemakers in China
Devices Cardiology Regulatory
 HSMN NewsFeed - 12 Sep 2012
GenMark Diagnostics Receives FDA Clearance for RVP Test
Diagnostics FDA
 HSMN NewsFeed - 11 Sep 2012
Varian Medical Systems Receives SFDA Clearance to Market the UNIQUE(TM) Radiotherapy System in China
Devices Oncology Regulatory
 HSMN NewsFeed - 11 Sep 2012
Covidien Announces FDA 510(k) Clearance of LigaSure(TM) Small Jaw Instrument for Ear, Nose and Throat Surgical Procedures
Devices Surgery FDA
 HSMN NewsFeed - 10 Sep 2012
Abiomed Receives FDA 510(k) Clearance for New, Higher Flow Impella Percutaneous Heart Pump, With Peak Flows of 4L/min
Devices Cardiology FDA
 HSMN NewsFeed - 6 Sep 2012
SinuSys Receives CE Mark for AerOs(TM) Sinus DiIation System, Completes FDA 510(k) Submission
Devices Interventional FDA Regulatory
 HSMN NewsFeed - 5 Sep 2012
LipoScience Receives FDA Clearance for Vantera Clinical Analyzer
Diagnostics Personalized Medicine Cardiology FDA
 HSMN NewsFeed - 5 Sep 2012
Alvine Pharmaceuticals’ ALV003 Receives Fast Track Designation From the FDA for the Potential Treatment of Celiac Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 4 Sep 2012
LDR Announces FDA Clearance of the Avenue(R) L Lateral Lumbar Cage System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 4 Sep 2012
HemCon(R) GuardIVa(R) Antimicrobial Hemostatic IV Dressing Obtains Additional FDA Clearance and HCPCS Reimbursement Codes
Devices FDA Reimbursement
 HSMN NewsFeed - 4 Sep 2012
Higher dose of Novartis drug Exelon(R) Patch approved by FDA for patients with mild to moderate Alzheimer's disease
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 30 Aug 2012
Zynex Receives FDA 510(k) Clearance for InWave Medical Device
Devices Urology FDA
 HSMN NewsFeed - 30 Aug 2012
Teva Announces FDA Grants Approval for Tbo-filgrastim for the Treatment of Chemotherapy-Induced Neutropenia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 29 Aug 2012
U.S. FDA Grants Priority Review of ZYTIGA(R) (abiraterone acetate) sNDA for Treatment of Metastatic Castration-Resistant Prostate Cancer Before Chemotherapy
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 29 Aug 2012
Crospon Receives FDA Clearance for Barostat Option for EndoFLIP System
Devices Gastroenterology FDA
 HSMN NewsFeed - 29 Aug 2012
AngioDynamics Earns FDA Clearance for First Vascular Access Product With BioFlo Technology to Reduce Catheter-Related Thrombus
Devices FDA
 HSMN NewsFeed - 28 Aug 2012
Dynavax Announces FDA Advisory Committee to Review HEPLISAV(TM)
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Aug 2012
Symmetry Medical Announces FDA Clearance of Its FLASH PAK(R) Evolution Valve
Devices FDA
 HSMN NewsFeed - 28 Aug 2012
Covidien Receives FDA 510(k) Clearance for Groundbreaking iDrive(TM) Ultra Powered Stapling System
Devices Surgery FDA
 HSMN NewsFeed - 27 Aug 2012
FDA Approves Mallinckrodt’s EXALGO(R) (hydromorphone HCl) Extended-Release Tablets 32 mg (CII) for Opioid-Tolerant Patients with Moderate-to-Severe Chronic Pain
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Aug 2012
Toshiba’s Aquilion RXL Receives FDA Clearance
Devices Radiology FDA
 HSMN NewsFeed - 22 Aug 2012
Wockhardt receives tentative US FDA approval for generic version of anti-psychotic drug Geodon(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 22 Aug 2012
Toshiba Receives FDA Clearance for the New 8- and 32-Channel Titan 1.5T MR Systems
Devices Radiology FDA
 HSMN NewsFeed - 21 Aug 2012
Covalon Announces FDA Clearance for SurgiClear(TM) Antimicrobial Silicone Wound Dressing
Devices Wound Care Surgery FDA
 HSMN NewsFeed - 21 Aug 2012
FDA Clears Wireless ViSi(R) Mobile Patient Monitoring System Aimed at Enhancing Patient Safety for Ambulatory Hospital Patients
Devices Monitoring FDA
 HSMN NewsFeed - 20 Aug 2012
Reckitt Benckiser Pharmaceuticals Inc. Announces FDA Approval of Two New Dosage Strengths of Suboxone(R) Sublingual Film (C-III) for Maintenance Treatment of Opioid Dependence
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Aug 2012
Pharmalucence Announces FDA Approval and Orphan Drug Designation for Use of Sulfur Colloid Injection to Locate Lymph Nodes in Malignant Melanoma Patients
Biopharmaceuticals Diagnostics Oncology FDA
 HSMN NewsFeed - 14 Aug 2012
JARVIK HEART Announces Full FDA Approval of the Jarvik 2000 Destination Therapy Trial
Devices Cardiology FDA
 HSMN NewsFeed - 13 Aug 2012
Teva Receives FDA Acceptance of Its New Drug Application for Quartette(TM) (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) for the Prevention of Pregnancy
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Aug 2012
Sanofi Announces FDA Approval for Auvi-Q(TM), First Voice-guided Epinephrine Auto-injector for Patients with Life-threatening Allergies
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 10 Aug 2012
PharmAthene Receives FDA Notification On SparVax(TM)
Biopharmaceuticals FDA
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