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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 - 29 Oct 2013
Ethicon Receives 510(k) Clearance of Ear, Nose and Throat (ENT) Indication for ENSEAL(R) Tissue Sealers
Devices FDA
 HSMN NewsFeed - 29 Oct 2013
Pharmalink Receives US Orphan Drug Designation for Busulipo(TM), its Novel Oncology Product for Bone Marrow Transplantation
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 28 Oct 2013
Ethicon Receives 510(k) Clearance for New HARMONIC ACE(R)+ 7 Shears with Advanced Hemostasis
Devices Surgery FDA
 HSMN NewsFeed - 25 Oct 2013
Abbott's First-In-Class MitraClip(R) Device Now Available for U.S. Patients
Devices Interventional Cardiology FDA Product Launch
 HSMN NewsFeed - 23 Oct 2013
FDA Approves JUVÉDERM VOLUMA(TM) XC
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 23 Oct 2013
FDA Grants Lilly's Ramucirumab Priority Review as a Potential Single-Agent Treatment for Advanced Gastric Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 22 Oct 2013
Cardiovascular Systems, Inc. Receives Coronary FDA Approval
Devices Interventional Cardiology FDA Product Launch
 HSMN NewsFeed - 21 Oct 2013
Biomet Announces First U.S. Implantation of Comprehensive(R) Nano Stemless Shoulder as Part of an FDA Regulated Clinical Study
Devices Orthopaedic
 HSMN NewsFeed - 21 Oct 2013
Bayer's CONTOUR(R) NEXT LINK Cleared For Use With Medtronic's New MiniMed(R) 530G With Enlite(R)
Devices Drug Delivery Monitoring Endocrinology FDA
 HSMN NewsFeed - 21 Oct 2013
Cubist Announces FDA Approval for Expanded Use of ENTEREG(R)
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 18 Oct 2013
Cimzia(R) (Certolizumab Pegol) Approved by FDA for Treatment of Adults with Active Ankylosing Spondylitis
Biopharmaceuticals FDA
 HSMN NewsFeed - 14 Oct 2013
Teva Announces FDA Approval of Generic TOBI(R) in the United States
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 11 Oct 2013
Crospon Receives FDA Clearance for EsoFLIP(R) Dilation Catheter
Devices Gastroenterology FDA
 HSMN NewsFeed - 11 Oct 2013
FDA Files Genentech’s Supplemental Biologics License Application of Xolair(R) (omalizumab) for Chronic Idiopathic Urticaria (CIU)
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 10 Oct 2013
Integra LifeSciences Receives FDA Clearance for Integra(R) Laminoplasty System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 10 Oct 2013
MAQUET Medical Systems USA Receives 510(k) Clearance for VOLISTA(TM) Surgical Lighting System
Devices Surgery FDA
 HSMN NewsFeed - 9 Oct 2013
Brainlab Announces FDA Clearance for Airo(R) Mobile Intraoperative CT
Devices Surgery Radiology FDA
 HSMN NewsFeed - 9 Oct 2013
USGI Medical Receives FDA Approval to Launch Head-to-Head Pivotal Study to Determine Safety, Effectiveness of Incisionless, Endoscopic Weight Loss Procedure
Devices Surgery FDA
 HSMN NewsFeed - 9 Oct 2013
Integra LifeSciences Announces Introduction of Integra(R) Hollywood(TM) NanoMetalene(TM) Interbody Device
Devices Orthopaedic Neurosurgery Product Launch FDA
 HSMN NewsFeed - 9 Oct 2013
Tyber Medical Receives 510 (k) Clearance For TyPEEK(TM) And PEEK Interbody Systems
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 8 Oct 2013
Advanced Catheter Therapies Receives FDA 510(k) Clearance on Occlusion Perfusion Catheter
Devices Interventional Cardiology Drug Delivery FDA
 HSMN NewsFeed - 7 Oct 2013
Par Pharmaceutical Begins Shipment of Generic Kapvay(R)
Biopharmaceuticals Generics FDA Product Launch
 HSMN NewsFeed - 4 Oct 2013
Discovery Labs Announces FDA Approval of SURFAXIN(R) (lucinactant) Updated Product Specifications
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Oct 2013
Pfizer Inc. Announces FDA Approval of DUAVEE(TM) (conjugated estrogens/ bazedoxifene) for the Treatment of Moderate-to-Severe Vasomotor Symptoms (Hot Flashes) Associated with Menopause and the Prevention of Postmenopausal Osteoporosis [1]
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Oct 2013
Nucletron, an Elekta Company, Receives US FDA 510(k) Clearance for Esteya Electronic Brachytherapy System for Treating Skin Cancer
Devices Oncology FDA
 HSMN NewsFeed - 30 Sep 2013
FDA Rule Mandating Unique Device Identification for Reusable Medical Devices Creates New Market Opportunity for VeriTeQ in Breast Implant Sizers and Other Reprocessed Devices
Devices Surgery FDA
 HSMN NewsFeed - 30 Sep 2013
FDA Grants Orphan Drug Designation to Omeros' OMS824 for Huntington's Disease
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 30 Sep 2013
Cimzia(R) (certolizumab pegol) approved by the U.S. FDA for treatment of adult patients with active psoriatic arthritis
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Sep 2013
Medtronic Gains Approval of First Artificial Pancreas Device System with Threshold Suspend Automation
Devices Drug Delivery FDA
 HSMN NewsFeed - 26 Sep 2013
Integra LifeSciences Announces Resolution of Warning Letter Related to Its Plainsboro, NJ, Manufacturing Facility
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 26 Sep 2013
Lumena Pharmaceuticals Receives Orphan Drug Designation from US Food & Drug Administration for LUM001 in Four Rare Liver Diseases
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Sep 2013
Par Pharmaceutical Begins Shipment of Generic Glucotrol XL(R)
Biopharmaceuticals Generics FDA Product Launch
 HSMN NewsFeed - 24 Sep 2013
First U.S. Patient Treated Following FDA Clearance of NeoTract's UroLift(R) System
Devices Urology Product Launch
 HSMN NewsFeed - 24 Sep 2013
FDA Approves Medtronic's Complete 'SE' Vascular Stent for Use in Superficial Femoral and Proximal Popliteal (Leg) Arteries
Devices Interventional FDA
 HSMN NewsFeed - 24 Sep 2013
Solana Surgical Receives FDA Clearance, Launches the FuseFORCE(TM) SuperElastic Fixation System
Devices Orthopaedic FDA Product Launch
 HSMN NewsFeed - 24 Sep 2013
EnteroMedics on Track for Approval Decision in First Half of 2014 Following Formal Response to Premarket Approval Application From FDA
Devices FDA
 HSMN NewsFeed - 20 Sep 2013
Perrigo Company Appoints FDA Veteran As New Head Of Regulatory Review
Biopharmaceuticals Personnel
 HSMN NewsFeed - 16 Sep 2013
Quidel Receives Two FDA Clearances for Molecular Diagnostic Tests for Use on Life Technologies QuantStudio(TM) Dx
Diagnostics FDA
 HSMN NewsFeed - 16 Sep 2013
FDA Grants Soligenix Orphan Drug Designation for SGX94 for Treatment of Acute Radiation Syndrome
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 Sep 2013
Rehrig Pacific Company Receives FDA Approval for New Reusable Sharps Container
Devices FDA
 HSMN NewsFeed - 11 Sep 2013
Gore Receives First FDA Approval for Endovascular Repair of Aortic Dissection
Devices Interventional FDA
 HSMN NewsFeed - 6 Sep 2013
U.S. Food and Drug Administration Approves ABRAXANE(R) in Combination with Gemcitabine as First-Line Treatment of Patients with Metastatic Pancreatic Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 5 Sep 2013
StelKast Receives FDA Clearance of EXp(TM) for Proven Gen-Flex(TM) Total Knee System
Devices Orthopaedic FDA
 HSMN NewsFeed - 4 Sep 2013
Abyrx(TM), Inc. Receives FDA 510(k) Clearance for New Resorbable Hemostatic Bone Putty (Hemasorb Plus(TM))
Devices Surgery FDA
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