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Healthcare News Roundup: FDA

 HSMN NewsFeed - 27 Nov 2012
Given Imaging Submits PillCam(R) COLON 2 Application to FDA for U.S. Regulatory Clearance
Devices Gastroenterology FDA
 HSMN NewsFeed - 20 Nov 2012
Sunshine Heart Receives Unconditional FDA Approval for C-Pulse(R) System's U.S. Pivotal Trial
Devices Cardiology FDA
 HSMN NewsFeed - 20 Nov 2012
Ipsen and Inspiration Biopharmaceuticals Announce That OBI-1 Has Received Fast Track Designation from FDA for Acquired Hemophilia A
Biopharmaceuticals
 HSMN NewsFeed - 16 Nov 2012
Vitacon Receives FDA 510(k) Clearance and Creates US Presence
Devices Urology FDA
 HSMN NewsFeed - 13 Nov 2012
Nanosphere Receives FDA Clearance to Market Test for Detection of CYP2C19 Mutations Affecting Drug Metabolism
Diagnostics FDA
 HSMN NewsFeed - 8 Nov 2012
S.M.A.R.T.(R) Vascular Stent Systems Receive FDA Approval for Use in SFA
Devices Interventional FDA
 HSMN NewsFeed - 8 Nov 2012
FDA Grants Diazyme Clearance to Market a New Biomarker for Early Detection of Kidney Disease, on the SMART Point of Care System
Diagnostics FDA
 HSMN NewsFeed - 8 Nov 2012
Avinger’s Ocelot System is FDA Cleared
Devices Interventional FDA
 HSMN NewsFeed - 8 Nov 2012
Zogenix Announces FDA Advisory Committee Review of Zohydro(TM) ER for the Management of Chronic Pain
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Nov 2012
Angel(R) cPRP System Granted FDA 510(K) Clearance for Processing Blood and Bone Marrow Aspirate
Devices Regenerative Medicine Orthopaedic FDA
 HSMN NewsFeed - 8 Nov 2012
Albireo Has Been Granted Orphan Drug Designation for A4250 from the US FDA for the Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) and for Primary Biliary Cirrhosis (PBC)
Biopharmaceuticals
 HSMN NewsFeed - 7 Nov 2012
U.S. Food and Drug Administration Approves Pfizer’s XELJANZ(R) (tofacitinib citrate) for Adults with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Methotrexate
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Nov 2012
LDR Receives Approvable Letter from U.S. Food and Drug Administration for Two-Level Mobi-C(R) Cervical Disc
Devices Orthopaedic Neurosurgey FDA
 HSMN NewsFeed - 6 Nov 2012
Intersect ENT Announces FDA Approval of New Steroid-Releasing Implant, Allowing More Chronic Sinusitis Patients to Benefit from Localized Drug Delivery
Devices Drug Delivery
 HSMN NewsFeed - 1 Nov 2012
X-spine Announces FDA Clearance of Two New Spinal Systems
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 1 Nov 2012
Accuray Receives FDA 510(k) Clearance for New CyberKnife(R) M6(TM) Series, Merging Multileaf Collimation with Non-Isocentric Robotic Delivery
Devices Oncology FDA
 HSMN NewsFeed - 1 Nov 2012
SRS Medical acquires The Spanner(TM) Prostatic Stent from AbbeyMoor Medical, the first and only FDA cleared temporary stent for the male urethra
Devices Urology Acquisitions
 HSMN NewsFeed - 31 Oct 2012
Thermedical Receives FDA 510(k) Clearance for Promising New Ablation System
Devices Oncology Cardiology FDA
 HSMN NewsFeed - 30 Oct 2012
Cohera Medical Receives Approval for First Module of its Premarket Approval Application (PMA) for TissuGlu(R) Surgical Adhesive
Devices Surgery FDA
 HSMN NewsFeed - 29 Oct 2012
Bayer's Stivarga(R) (regorafenib) Tablets New Drug Application Granted Priority Review by U.S. FDA for the Treatment of Patients with Gastrointestinal Stromal Tumors
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 29 Oct 2012
MAQUET Cardiovascular Receives FDA 510(k) Clearance And CE Mark Approval For Its New SENSATION PLUS(R) 7.5Fr 40cc Intra-Aortic Balloon Catheter
Devices Cardiology FDA
 HSMN NewsFeed - 26 Oct 2012
NuVasive Announces PMA Approval of the PCM(R) Cervical Disc System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 26 Oct 2012
Teva Receives Approval For SYNRIBO(TM) (Omacetaxine Mepesuccinate) for Injection
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 24 Oct 2012
Providence Medical Technology Receives 510(k) Clearance for PMT Bone Screws
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 22 Oct 2012
STENTYS Receives FDA Approval to Initiate First U.S. Clinical Trial With Self-Apposing(R) Stent
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 22 Oct 2012
On-X Life Technologies Submits for FDA/CE Approval of Reduced Anticoagulation Indication for On-X Aortic Heart Valve
Devices Cardiology FDA Regulatory
 HSMN NewsFeed - 22 Oct 2012
FDA Approves New Non-Invasive, Non-Ionizing Radiation Therapy to Treat Pain from Bone Metastases
Devices Oncology FDA
 HSMN NewsFeed - 22 Oct 2012
Svelte Medical Systems Announces FDA Approval to Initiate a Pivotal Study of Its Coronary Stent Integrated Delivery System (IDS)
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 22 Oct 2012
Nuvo and Galderma Announce FDA Approval of Pliaglis(R)
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 22 Oct 2012
Supernus Receives FDA Approval for Oxtellar XR(TM) in Epilepsy
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 18 Oct 2012
VuCOMP’s M-Vu(R) Computer-Aided Detection (CAD) System Receives FDA Approval for Digital Mammography
Devices Radiology FDA
 HSMN NewsFeed - 18 Oct 2012
U.S. FDA Approves ThromboGenics' JETREA(R) (Ocriplasmin) for the Treatment of Symptomatic Vitreomacular Adhesion (VMA)
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 17 Oct 2012
Loma Vista Medical Receives FDA Clearance for its TRUE Dilatation(TM) Balloon Valvuloplasty Catheter
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 16 Oct 2012
Hologic Announces FDA Approval of APTIMA HPV 16 18/45 Genotype Assay for Use on the TIGRIS System
Diagnostics Oncology FDA
 HSMN NewsFeed - 12 Oct 2012
FDA Approves Expanded Indication for ACTEMRA(R) in Rheumatoid Arthritis
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Oct 2012
FDA Approves ABRAXANE(R) for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 11 Oct 2012
Alma Lasers Receives FDA Clearance for PixelRF Breakthrough Technology in Skin Resurfacing
Devices Dermatology FDA
 HSMN NewsFeed - 10 Oct 2012
Surefire Medical Receives FDA Clearance for Angiographic Catheters
Devices Radiology Interventional FDA
 HSMN NewsFeed - 9 Oct 2012
Baxano's iO-Tome(TM) Device Receives FDA Clearance
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 9 Oct 2012
Integra LifeSciences Receives FDA Clearance for Expanded Indication for Spinal Device
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 8 Oct 2012
Rusch(R) EZ-Blocker(TM) Endobronchial Blocker Receives 510(k) Clearance
Devices FDA
 HSMN NewsFeed - 8 Oct 2012
U.S. FDA Approves the Dexcom G4(TM) PLATINUM Continuous Glucose Monitor (CGM)
Devices Endocrinology Monitoring FDA
 HSMN NewsFeed - 4 Oct 2012
Covidien Announces FDA 510(k) Clearance and CE Mark for Nellcor(TM) Bedside Respiratory Patient Monitoring System
Devices Monitoring FDA
 HSMN NewsFeed - 4 Oct 2012
Volcano Announces CE Mark and 510(k) Clearance for New Visions(R) PV .035 Digital IVUS Catheter
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 4 Oct 2012
Sigma-Tau Pharmaceuticals, Inc. Receives FDA Approval of CYSTARAN(TM) (Cysteamine Ophthalmic Solution) 0.44% for Treatment of Corneal Cystine Crystals in Cystinosis Patients
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 4 Oct 2012
Boston Therapeutics Wins FDA Approval to File an Abbreviated New Drug Application for PAZAMET(TM) to Treat Diabetes
Biopharmaceuticals Endocrinology FDA
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