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

Healthcare News Roundup: FDA

HSMN NewsFeed - 19 Nov 2014
Argon Medical's CLEANER XT(TM) and CLEANER 15(TM) Rotational Thrombectomy Systems Receive FDA Clearance for Mechanical Declotting and Infusion in the Peripheral Vasculature
Devices Interventional FDA

HSMN NewsFeed - 18 Nov 2014
AdvanDx Receives FDA 510(k) Clearance for mecA XpressFISH(TM)
Diagnostics FDA

HSMN NewsFeed - 13 Nov 2014
Integra LifeSciences Announces FDA Clearance and Controlled Market Release of Expandable Interbody System for Spinal Surgery
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 12 Nov 2014
Par Pharmaceutical Announces First FDA Approval of Vasostrict(TM) (vasopressin injection, USP)
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Nov 2014
BioCardia(R), Inc. Announces FDA Acceptance of Phase III Clinical Trial Protocol Studying Bone Marrow-Derived Cell Therapy for Heart Failure Patients
Regenerative Medicine Cardiology FDA

HSMN NewsFeed - 10 Nov 2014
Zimmer Announces FDA Clearance of the Stand-alone Optio-C(R) Anterior Cervical System for use with Structural Allograft/Autograft
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 10 Nov 2014
ImThera Medical, Inc. Receives FDA Approval for Pivotal Study for Obstructive Sleep Apnea Device
Devices FDA

HSMN NewsFeed - 5 Nov 2014
FDA Grants Orphan Drug Designation to Merrimack Pharmaceuticals' MM-141 for the Treatment of Pancreatic Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 30 Oct 2014
U.S. FDA Approves Once-Daily XIGDUO(TM) XR Tablets for Adults with Type 2 Diabetes
Biopharmaceuticals Endocrinology FDA

HSMN NewsFeed - 28 Oct 2014
Dallen Medical Receives FDA Clearance for Tensyn(TM) Band for AC/CC Joint Stabilization
Devices Orthopaedic FDA

HSMN NewsFeed - 28 Oct 2014
RaySearch Laboratories: Raysearch Receives FDA Clearance for RayStation 4.5 Featuring Ultrafast and Robust Optimization
Devices Oncology FDA

HSMN NewsFeed - 27 Oct 2014
St. Jude Medical Receives FDA Approval of TactiCath Quartz Contact Force Ablation Catheter for Treatment of Atrial Fibrillation
Devices Cardiology FDA

HSMN NewsFeed - 24 Oct 2014
Zyno Medical, LLC Receives FDA 510(k) Clearance for Ambulatory Infusion Pump
Devices FDA

HSMN NewsFeed - 16 Oct 2014
FDA Approves Boehringer Ingelheim's OFEV(R) (nintedanib) as First Kinase Inhibitor to Treat Idiopathic Pulmonary Fibrosis
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Oct 2014
FDA Approves VisionCare's Telescope Implant for Macular Degeneration in Patients 65 Years and Older
Devices Ophthalmology FDA

HSMN NewsFeed - 13 Oct 2014
FDA Approves AKYNZEO(R) (netupitant/palonosetron) for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV)
Biopharmaceuticals FDA

HSMN NewsFeed - 9 Oct 2014
Neovasc Receives FDA Conditional Approval to Initiate TIARA-I Trial in US: A Multinational, Multicenter Early Feasibility Trial of the Tiara(TM) Transcatheter Mitral Valve
Devices Interventional Cardiology FDA

HSMN NewsFeed - 8 Oct 2014
Kubtec(R) Announces FDA Approval of World’s First Breast Specimen Tomosynthesis System During Breast Cancer Awareness Month
Devices FDA

HSMN NewsFeed - 2 Oct 2014
Esaote Receives FDA Clearance for Its Portable MyLab Gamma Ultrasound System
Devices FDA

HSMN NewsFeed - 29 Sep 2014
Allergan Announces FDA Approves Revised Indication for OZURDEX(R) (dexamethasone intravitreal implant) 0.7 mg for the Treatment of Diabetic Macular Edema
Biopharmaceuticals Ophthalmology Drug Delivery FDA

HSMN NewsFeed - 29 Sep 2014
Intuitive Surgical Receives FDA Clearance for First Single-Site(R) Wristed Needle Driver for da Vinci(R) Si(R) Surgical System
Devices Surgery FDA

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