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Healthcare News Roundup: FDA

 HSMN NewsFeed - 17 Apr 2012
QIAGEN Receives FDA Clearances for Rotor-Gene Q MDx Instrument and Compatible Influenza A/B Assay
Diagnostics FDA
 HSMN NewsFeed - 13 Apr 2012
Rib-X Pharmaceuticals Appoints Infectious Disease Expert and Former FDA Deputy Director Matthew Wikler, MD as Chief Development Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 13 Apr 2012
Chromogenex Receives FDA Clearance for Circumferential Reduction for i-Lipo Body Contouring System
Devices Dermatology FDA
 HSMN NewsFeed - 11 Apr 2012
FDA Panel Recommends Approval for U-Systems’ Breast Cancer Screening Tool for Women with Dense Breasts
Devices Oncology FDA
 HSMN NewsFeed - 10 Apr 2012
Tangent Medical Submits FDA 510(k) for NovaCath(TM) Secure IV Catheter System
Devices FDA
 HSMN NewsFeed - 10 Apr 2012
Medtronic Receives FDA Approval to Treat Mildly Symptomatic Heart Failure Patients Through Expanded Indication for CRT-D
Devices Cardiology FDA
 HSMN NewsFeed - 6 Apr 2012
Arteriocyte Receives FDA Approval to Initiate Compartment Syndrome Trial for Amputation Prevention Focused on Wounded Warriors
Devices Orthopaedic FDA
 HSMN NewsFeed - 5 Apr 2012
FDA Decides Teva is Sole First-to-File on Provigil(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 4 Apr 2012
FDA Sets Date for Advisory Committee Review of OraSure Over-the-Counter Rapid HIV Test
Diagnostics HIV/AIDS FDA
 HSMN NewsFeed - 4 Apr 2012
Anulex Technologies, Inc. Announces FDA Clearance for Expanded Indications of fiXate(TM) Tissue Band
Devices Neurology FDA
 HSMN NewsFeed - 3 Apr 2012
Neupro(R) Approved by U.S. FDA for Parkinson’s Disease and Restless Legs Syndrome
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 2 Apr 2012
FDA Approves Levemir(R) Pregnancy Category Change for Women with Diabetes
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 27 Mar 2012
FDA Approves LINX(R) System for the Treatment of Reflux Disease
Devices Gastroenterology FDA
 HSMN NewsFeed - 23 Mar 2012
VectraCor Receives FDA Approval for Real-Time Detection of ECG Changes Suggestive of AMI
Devices Monitoring Cardiology FDA
 HSMN NewsFeed - 20 Mar 2012
Covidien Announces FDA 510(k) Clearance of Nellcor(TM) Respiration Rate Software
Devices Monitoring FDA
 HSMN NewsFeed - 19 Mar 2012
Cameron Health’s S-ICD(R) System Scheduled for FDA Panel Review on April 26, 2012
Devices Cardiology FDA
 HSMN NewsFeed - 16 Mar 2012
FDA Grants Cytori 510(k) Clearance for Puregraft(R) 850
Devices FDA
 HSMN NewsFeed - 14 Mar 2012
FDA Approves BINOSTO(TM), First and Only Effervescent Osteoporosis Treatment in a Buffered Solution
Biopharmaceuticals Drug Delivery Licensing FDA
 HSMN NewsFeed - 14 Mar 2012
Sunshine Heart Announces FDA Completes Review of C-Pulse(R) Feasibility Data
Devices Cardiology FDA
 HSMN NewsFeed - 13 Mar 2012
Cornerstone Therapeutics Receives FDA Acceptance for CRTX 080 NDA for Treatment of Hyponatremia
Biopharmaceuticals
 HSMN NewsFeed - 13 Mar 2012
AstraZeneca Files Lawsuit against the FDA for Decision Regarding Quetiapine Product Labeling and Exclusivity
Biopharmaceuticals Generics Litigation
 HSMN NewsFeed - 12 Mar 2012
Organogenesis Inc. Announces FDA Approval of GINTUIT(TM) for Oral Soft Tissue Regeneration
Regenerative Medicine Wound Care FDA
 HSMN NewsFeed - 7 Mar 2012
Abbott's Absolute Pro(R) Vascular Self-Expanding Stent System Receives FDA Approval for Treatment of Iliac Artery Disease
Devices Interventional FDA
 HSMN NewsFeed - 5 Mar 2012
Covidien Revascularization Device Receives FDA Clearance
Devices Interventional Neurology FDA
 HSMN NewsFeed - 29 Feb 2012
Conceptus(R) Receives FDA Approval for Compatible Use of Hologic's NovaSure(R) with Essure(R) Inserts in Place
Devices
 HSMN NewsFeed - 28 Feb 2012
FDA Approves AVONEX(R) PEN(TM) and Dose Titration Regimen
Biopharmaceuticals Drug Delivery Neurology FDA
 HSMN NewsFeed - 27 Feb 2012
JARVIK HEART Announces FDA Conditional Approval of Trial Using the Jarvik 2000(R) Heart for Destination Therapy
Devices Cardiology FDA
 HSMN NewsFeed - 27 Feb 2012
FDA Panel Meeting Scheduled for U-Systems’ Automated Breast Ultrasound (ABUS) System
Devices Oncology FDA
 HSMN NewsFeed - 27 Feb 2012
CASMED's FORE-SIGHT(R) Absolute Tissue Oximeter Gains FDA Clearance for Use on Neonatal Abdomen
Devices Monitoring FDA
 HSMN NewsFeed - 24 Feb 2012
invendo medical Announces 510(k) Clearance by FDA for Advancement-Assisted Single-Use Colonoscopy System
Devices Gastroenterology FDA
 HSMN NewsFeed - 23 Feb 2012
Mylan Receives Tentative FDA Approval Through PEPFAR for Pediatric HIV/AIDS Therapy
Biopharmaceuticals Generics HIV/AIDS FDA
 HSMN NewsFeed - 23 Feb 2012
Boston Scientific Receives Industry's First FDA Approval for Drug-Eluting Coronary Stent Use in Heart Attack Patients
Devices Interventional Cardiology FDA
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