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

Healthcare News Roundup: FDA

HSMN NewsFeed - 8 Sep 2009
IMRIS receives FDA clearance for IMRISNV and IMRIScardio
Devices Radiology Cardiology Neurology FDA

HSMN NewsFeed - 8 Sep 2009
Salix Receives FDA Marketing Approval for METOZOLV ODT (Orally Disintegrating Tablets) for Relief of Diabetic Gastroparesis and Symptomatic Documented GERD
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 8 Sep 2009
Cochlear Americas Announces FDA Approval of the Nucleus(R) 5 System, the Newest and Most Advanced Cochlear Implant System
Devices FDA

HSMN NewsFeed - 8 Sep 2009
DuraSeal(TM) Spine Sealant Receives FDA Approval
Devices Orthopaedic Neurosurgery. FDA

HSMN NewsFeed - 8 Sep 2009
FDA Grants Protalix Orphan Drug Designation for prGCD
Biopharmaceuticals FDA

HSMN NewsFeed - 3 Sep 2009
Luminex Receives 510(K) Clearance for New Cystic Fibrosis Test
Diagnostics FDA

HSMN NewsFeed - 3 Sep 2009
MEDICREA PASS(R) LP Iliac Fixation Receives FDA Clearance
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 3 Sep 2009
Shire Announces FDA Approval of Once-Daily INTUNIV(TM) (guanfacine) Extended Release Tablets for the Treatment of ADHD in Children and Adolescents Aged 6 to 17
Biopharmaceuticals FDA

HSMN NewsFeed - 2 Sep 2009
FDA Advisory Committee Recommends Gloucester Pharmaceuticals' Romidepsin for Approval for Cutaneous T-cell Lymphoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 2 Sep 2009
FDA to Review Supplement Containing Long-Term Survival Data For VELCADE(R) (bortezomib) For Injection
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 2 Sep 2009
Potential Breakthrough Cancer Treatment Now Available From Vascular Designs
Devices Drug Delivery Oncology FDA

HSMN NewsFeed - 2 Sep 2009
Meda: FDA Approval of the First Once-Daily Nasal Antihistamine
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Sep 2009
FDA Clears Hologic's MammoSite(R) ML Radiation Therapy System for the Treatment of Early-Stage Breast Cancer
Devices Oncology FDA

HSMN NewsFeed - 31 Aug 2009
Hospira Receives FDA Approval for Six New Presentations of Heparin
Biopharmaceuticals FDA

HSMN NewsFeed - 31 Aug 2009
FDA Approves Valcyte(R) (valganciclovir hydrochloride) to Prevent Cytomegalovirus (CMV) Disease in Pediatric Patients Who Receive Heart or Kidney Transplants
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Aug 2009
Eurand Granted FDA Approval for ZENPEP(TM)
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Aug 2009
Geron Comments on FDA Hold on Spinal Cord Injury Trial
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Aug 2009
ATS Medical Announces FDA Approval for a Landmark Clinical Investigation of the ATS 3f Aortic Bioprosthesis
Devices Cardiology FDA

HSMN NewsFeed - 25 Aug 2009
CAS Medical Systems, Inc. Announces FDA 510(k) Clearance Expanding Labeling for FORE-SIGHT Cerebral Oximeter
Devices Monitoring FDA

HSMN NewsFeed - 25 Aug 2009
Protalix Receives FDA Fast Track Designation for prGCD
Biopharmaceuticals FDA

HSMN NewsFeed - 25 Aug 2009
APP Pharmaceuticals Receives Approval for Penicillin G Potassium for Injection, USP
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 24 Aug 2009
FDA Approves XYZAL(R) For Use In Children Age Six Months And Older For The Relief Of Perennial Allergic Rhinitis And Chronic Idiopathic Urticaria
Biopharmaceuticals FDA

HSMN NewsFeed - 24 Aug 2009
Aperio Receives Second FDA Clearance for HER2 Image Analysis Application for Breast Cancer
Diagnostics Oncology FDA

HSMN NewsFeed - 21 Aug 2009
AspenBio Pharma 510(k) Filing for AppyScore Advances in FDA Review With Request for Additional Information
Diagnostics FDA

HSMN NewsFeed - 21 Aug 2009
Stemedica Requests Pre-IND Meeting With FDA
Regenerative Medicine Neurology FDA

HSMN NewsFeed - 19 Aug 2009
Smith & Nephew Takes Single Injection PMA to Next Stage
Devices Orthopaedic FDA

HSMN NewsFeed - 19 Aug 2009
EDAP Receives U.S. FDA 510(k) Approval for Sonolith I-Sys
Devices Urology FDA

HSMN NewsFeed - 18 Aug 2009
Par Pharmaceutical & Aveva Drug Delivery Systems Receive Final Approval to Market Generic Catapres TTS(R)
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 18 Aug 2009
Mylan's Matrix Receives First and Only Tentative FDA Approval Under PEPFAR for Generic Version of Atripla(R) HIV Treatment
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 18 Aug 2009
CryoLife Announces Implants of First FDA-Cleared SynerGraft(R) Processed Human Cardiac Patch Material
Devices Cardiology

HSMN NewsFeed - 18 Aug 2009
IsoRay Announces FDA Clearance Supporting Enhanced Loading and Delivery Methods for the Treatment of Lung, Head and Neck, and Other Tumors
Devices Oncology FDA

HSMN NewsFeed - 14 Aug 2009
Reverse Medical Corporation Receives US FDA 510(k) Clearance for the ReCruit(TM) Microcatheter for Use Including Neuro Interventional Procedures
Devices Interventional Neuro FDA

HSMN NewsFeed - 11 Aug 2009
Teva Announces Approval and Launch of Oxaliplatin Injection
Biopharmaceuticals Generics Oncology FDA

HSMN NewsFeed - 11 Aug 2009
Hospira Launches Generic Oxaliplatin Injection
Biopharmaceuticals Generics Oncology FDA

HSMN NewsFeed - 11 Aug 2009
Bovie Medical Corporation Announces FDA 510(k) Clearance to Market Its J-Plasma Electrosurgical Generator and Handpiece
Devices Surgery FDA

HSMN NewsFeed - 10 Aug 2009
APP Pharmaceuticals Receives Approval for Idarubicin HCI Injection
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 4 Aug 2009
Heart Force Medical Inc. Receives USFDA 510(k) Clearance of Its dBG 300 Digital Ballistocardiograph
Devices Cardiology Monitoring FDA

HSMN NewsFeed - 4 Aug 2009
PEAK Surgical Introduces PEAK PlasmaBlade(TM) TnA
Devices Surgery FDA

HSMN NewsFeed - 4 Aug 2009
Ferring Pharmaceuticals Announces Trade Name FIRMAGON(R) (degarelix for injection) for Advanced Prostate Cancer Treatment
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 4 Aug 2009
FDA Approves LIVALO(R) for Primary Hypercholesterolemia and Combined Dyslipidemia
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 4 Aug 2009
DOR BioPharma Receives FDA Orphan Drug Designation for orBec(R) for the Treatment of Chronic Gastrointestinal GVHD
Biopharmaceuticals FDA

HSMN NewsFeed - 3 Aug 2009
Watson Pharmaceuticals Receives FDA Approval for Generic Toprol XL(R) 25 MG and 50 MG
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 3 Aug 2009
Perrigo Announces FDA Approval for Generic Version of NASACORT(R) AQ
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 3 Aug 2009
Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 3 Aug 2009
FDA Approves Avastin for the Most Common Type of Kidney Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 31 Jul 2009
PharmaForce Inc. Receives FDA Approval for First Generic of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 31 Jul 2009
U.S. Food and Drug Administration's Arthritis Advisory Committee Confirms Date to Review XIAFLEX(TM) for the Treatment of Dupuytren's Contracture
Biopharmaceuticals FDA

HSMN NewsFeed - 29 Jul 2009
FDA Approves Sculptra(R)Aesthetic, a Facial Injectable for Correction of Nasolabial Folds and Other Facial Wrinkles
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 29 Jul 2009
Vystar(R) Corporation and Alatech Healthcare, LLC Announce FDA 510(k) Clearance for Exam Gloves Made with Vytex(R) NRL
Devices FDA

HSMN NewsFeed - 29 Jul 2009
New ACTICOAT(TM) Silver Coated Anti-microbial Barrier Dressing Receives 510(k) Clearance from the US FDA
Biopharmaceuticals Devices Wound Care FDA

HSMN NewsFeed - 29 Jul 2009
Response Biomedical Receives U.S. FDA 510(k) Market Clearance of Rapid Respiratory Syncytial Virus Test
Diagnostics FDA

HSMN NewsFeed - 28 Jul 2009
United States FDA Clears the REGEN Trial to Test Bioheart's Combination Gene and Stem Cell Therapy in Heart Failure Patients
Regenerative Medicine Cardiology FDA

HSMN NewsFeed - 24 Jul 2009
FDA Grants First Authorization of a Commercial 2009 H1N1 Flu Test for use During Pandemic Flu Emergency to Quest Diagnostics' Focus Diagnostics Business
Diagnostics FDA

HSMN NewsFeed - 24 Jul 2009
Cyberonics Provides Update on Depression Post-Approval Study
Devices Neurology FDA

HSMN NewsFeed - 24 Jul 2009
Neusoft Medical's Latest Innovation, NeuViz 16 CT Scanner, Approved by FDA for the U.S. Market
Devices Radiology FDA

HSMN NewsFeed - 24 Jul 2009
Elekta CMS Software Receives FDA 510(k) Clearance for Monaco VMAT Treatment Planning Solution
Devices Oncology FDA

HSMN NewsFeed - 23 Jul 2009
FDA Classifies Medtronic Voluntary February Recall for Intrepid Intervertebral Body Fusion Device as Class II
Devices Orthopaedic Neurosurgery Product Recall

HSMN NewsFeed - 23 Jul 2009
Allergan Receives FDA Approval for ACUVAIL Ophthalmic Solution for the Treatment of Pain and Inflammation Following Cataract Surgery
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 22 Jul 2009
Bovie Medical Corporation Announces 510(k) Submissions to the FDA for Its Seal-N-Cut Vessel Sealing Instruments
Devices Surgery FDA

HSMN NewsFeed - 21 Jul 2009
Gore Receives FDA Approval for Next Generation of Large Diameter GORE VIABAHN(R) Endoprosthesis with Heparin Bioactive Surface
Devices Interventional FDA

HSMN NewsFeed - 21 Jul 2009
Masimo Receives FDA Clearance for New Rainbow(R) Resposable(TM) Sensor System
Devices Monitoring FDA

HSMN NewsFeed - 21 Jul 2009
St. Jude Medical Announces FDA Approval of Accent RF and Anthem RF Pacemakers Equipped With Wireless Technology
Devices Cardiology FDA

HSMN NewsFeed - 21 Jul 2009
FDA Designates Fast Track Status for Apaziquone (EOquin(R)) for Bladder Cancer
Biopharmaceuticals FDA

HSMN NewsFeed - 21 Jul 2009
FDA Approves Tekturna HCT(R) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent
Biopharmaceuticals FDA

HSMN NewsFeed - 20 Jul 2009
Mylan Receives FDA Approval for Additional Strengths of the Antipsychotic Haloperidol
Biopharmaceuticals FDA

HSMN NewsFeed - 20 Jul 2009
LDR Announces FDA Clearance of the ROI-C Cervical Cage
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 20 Jul 2009
ImClone Systems and Bristol-Myers Squibb Announce Revisions to ERBITUX(R) (cetuximab) U.S. Product Labeling for Metastatic Colorectal Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 17 Jul 2009
Cytori's Celution(R) 700 System to be Regulated as a Medical Device by U.S. FDA
Devices

HSMN NewsFeed - 17 Jul 2009
Meda: Onsolis receives FDA approval
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 16 Jul 2009
Medtronic Files Pre-Market Approval Application for FDA Approval of Deep Brain Stimulation for Treatment-Resistant Epilepsy
Devices Neurology FDA

HSMN NewsFeed - 16 Jul 2009
Sumavel(TM) DosePro(TM) (sumatriptan injection) Approved by FDA for Acute Migraine and Cluster Headache: First Product Featuring Novel DosePro Needle-Free Delivery System
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Jul 2009
FDA Approves Boston Scientific's TAXUS(R) Liberte(R) Long Stent
Devices Interventional Cardiology FDA

HSMN NewsFeed - 16 Jul 2009
Mylan Receives FDA Approval for Generic Version of Thyroid Deficiency Treatment Cytomel(R)
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 16 Jul 2009
Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease
Biopharmaceuticals FDA

HSMN NewsFeed - 15 Jul 2009
FDA Approves NovoLog(R) Labeling Update
Biopharmaceuticals Endocrinology FDA

HSMN NewsFeed - 15 Jul 2009
Centocor Ortho Biotech Statement on the FDA ODAC Opinion Regarding Trabectedin for Relapsed Ovarian Cancer
Biopharmaceuticals Oncology FDA

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