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Healthcare News Roundup: FDA

 HSMN NewsFeed - 22 Mar 2011
LensAR(TM) Laser System Receives FDA Clearance for Lens Fragmentation and Anterior Capsulotomy in Cataract Surgery
Devices Ophthalmology FDA
 HSMN NewsFeed - 22 Mar 2011
Two-Level Mobi-C(R) Cervical Artificial Disc PMA Submitted by LDR
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 22 Mar 2011
FDA Accepts for Review Spectrum Pharmaceuticals’ ZEVALIN(R) Submission for the Removal of the Bioscan
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 18 Mar 2011
Covidien Announces FDA Advisory Committee Unanimously Recommends Approval for Pipeline(TM) Embolization Device
Devices Neurology Interventional FDA
 HSMN NewsFeed - 18 Mar 2011
Lilly and Avid Receive Complete Response Letter from FDA for Amyvid (florbetapir F 18 injection)
Biopharmaceuticals Radiology FDA
 HSMN NewsFeed - 17 Mar 2011
Cardiovascular Systems Receives FDA 510(k) Marketing Clearance for Stealth 360°(TM) Orbital PAD System
Devices Interventional FDA
 HSMN NewsFeed - 16 Mar 2011
Fujifilm Submits 510(K) Application to FDA for Aspire HD FFDM System
Devices Radiology Oncology FDA
 HSMN NewsFeed - 15 Mar 2011
Merit Medical Announces 510(k) Clearance for the ASAP(TM) Thrombus Aspiration Catheter
Devices Interventional FDA
 HSMN NewsFeed - 15 Mar 2011
U.S. FDA Approves Bayer's Gadavist (Gadobutrol) Injection for MRI of the Central Nervous System
Biopharmaceuticals Radiology FDA
 HSMN NewsFeed - 11 Mar 2011
Lantheus Medical Imaging Receives Special Protocol Assessment Approval from FDA for Phase 3 Trial of Flurpiridaz F-18 for the Diagnosis of Coronary Artery Disease
Biopharmaceuticals Radiology Cardiology FDA
 HSMN NewsFeed - 10 Mar 2011
Covidien Receives FDA Approval for South African-Produced Medical Isotope Based on Low-Enriched Uranium
Devices Radiology FDA
 HSMN NewsFeed - 10 Mar 2011
Teleflex Announces FDA Clearance to Market Arrow NextStep Antegrade Catheter for Chronic Hemodialysis
Devices FDA
 HSMN NewsFeed - 10 Mar 2011
Given Imaging Receives FDA Clearance for Expanded PillCam(R) SB Indications
Devices Gastroenterology FDA
 HSMN NewsFeed - 9 Mar 2011
Medtronic Resolves FDA Warning Letters
Devices Cardiology Neurology FDA
 HSMN NewsFeed - 9 Mar 2011
Tenex Health Receives FDA Clearance for Innovative TX1(TM) Tissue Removal System
Devices FDA
 HSMN NewsFeed - 7 Mar 2011
OSI Systems Receives FDA Clearance for Enhanced Flow Meter Used in Anesthesia Delivery
Devices FDA
 HSMN NewsFeed - 7 Mar 2011
Guided Therapeutics Provides Update on FDA PMA Review of Cervical Cancer Test
Devices Diagnostics Oncology FDA
 HSMN NewsFeed - 7 Mar 2011
Breathe Technologies Receives FDA Clearance for Home Use of Portable Ventilator
Devices Personnel FDA
 HSMN NewsFeed - 1 Mar 2011
Valeritas Receives FDA 510(k) Clearance for the V-Go Disposable Insulin Delivery Device for Use with NovoLog(R)
Devices Drug Delivery FDA
 HSMN NewsFeed - 1 Mar 2011
Forest Announces FDA Approval of Daliresp(TM) (Roflumilast) as a Treatment to Reduce the Risk of COPD Exacerbations in Patients with Severe COPD Associated with Chronic Bronchitis and a History of Exacerbations
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Feb 2011
FDA Approves INTUNIV(R) (guanfacine) Extended-Release Tablets for Use as Adjunctive Therapy to Stimulants for the Treatment of ADHD in Children and Adolescents
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Feb 2011
Derma Sciences Receives FDA Clearance for MEDIHONEY(R) Gel
Devices Wound Care FDA
 HSMN NewsFeed - 28 Feb 2011
Shire Files Complete Response to FDA's Not Approvable Letter for FIRAZYR(R) (icatibant) for the Treatment of Acute Attacks of Hereditary Angioedema
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Feb 2011
Ascom’s ClinicalConneX | Cardiomax achieves FDA Clearance
Devices Monitoring FDA
 HSMN NewsFeed - 28 Feb 2011
Santarus and Pharming Announce Receipt of FDA Refusal to File Letter for RHUCIN Biologics License Application
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Feb 2011
FDA Grants Full Approval for PROMACTA(R) (eltrombopag) for Treatment of Rare Blood Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Feb 2011
FDA Issues Complete Response Letter for Taliglucerase Alfa New Drug Application
Biopharmaceuticals
 HSMN NewsFeed - 24 Feb 2011
FDA Grants Genentech a Hearing on Avastin’s Use for Metastatic Breast Cancer in the United States
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 23 Feb 2011
Mindray Announces FDA 510(k) Clearance of Its A5 Anesthesia System
Devices FDA
 HSMN NewsFeed - 23 Feb 2011
Entellus Medical(TM) Receives FDA 510(k) Clearance for FinESS(TM) Endoscope
Devices FDA
 HSMN NewsFeed - 23 Feb 2011
Sunesis Receives FDA Fast Track Designation for Vosaroxin in AML
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 22 Feb 2011
OraSure Technologies Receives FDA Approval for Its OraQuick(R) HCV Rapid Test Using Fingerstick Whole Blood
Diagnostics FDA
 HSMN NewsFeed - 22 Feb 2011
Delcath Systems Receives Refusal to File Letter From FDA
Devices Biopharmaceuticals Drug Delivery Oncology FDA
 HSMN NewsFeed - 20 Feb 2011
Fresenius Medical Care Receives FDA Clearance for 2008K@home(TM) Dialysis Machine
Devices FDA
 HSMN NewsFeed - 18 Feb 2011
Impax Laboratories Receives Final FDA Approval for Generic Adoxa(R) 150 mg Capsules
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 18 Feb 2011
Zimmer Spine Introduces Industry's First Porous Metal Cervical Interbody Device
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 17 Feb 2011
Gore Announces FDA Approval of Next Evolution of GORE(R) VIABAHN(R) Endoprosthesis
Devices Interventional FDA
 HSMN NewsFeed - 16 Feb 2011
FDA Classifies Labeling Corrections Related to Occurrence of Pocket Fills During a SynchroMed(R) Implantable Infusion Pump Refill as a Class I Recall
Devices Drug Delivery Product Recall
 HSMN NewsFeed - 16 Feb 2011
Covidien Announces FDA 510(k) Clearance of New LigaSure(TM) Instrument
Devices Surgery FDA
 HSMN NewsFeed - 16 Feb 2011
Toshiba Announces FDA Clearance of Auto-IMT Ultrasound Software
Devices FDA
 HSMN NewsFeed - 15 Feb 2011
Venous Health Systems Receives FDA Clearance to Commercialize Fully Portable Pneumatic Compression System to Treat Vascular Insufficiency
Devices FDA
 HSMN NewsFeed - 15 Feb 2011
TomTec Receives FDA 510(k) Clearance for 4D MV-Assessment(R) 2.0 Software- the Solution for Improved Diagnostic Confidence in Mitral Valve Diagnostic Using 4D Ultrasound
Devices FDA
 HSMN NewsFeed - 15 Feb 2011
ArthroCare Receives FDA Clearance for Spartan 5.5 Needled Suture Implant
Devices Orthopaedic FDA
 HSMN NewsFeed - 11 Feb 2011
Hologic Receives FDA Approval for First 3-D Digital Mammography (Breast Tomosynthesis) System
Devices Radiology FDA
 HSMN NewsFeed - 11 Feb 2011
Stryker Receives FDA 510(k) Clearance to Market Modular Dual Mobility Acetabular (Hip) System
Devices Orthopaedic FDA
 HSMN NewsFeed - 11 Feb 2011
Cardiovascular Systems Files Special 510(k) for Stealth 360°(TM) Orbital Pad System
Devices Interventional FDA
 HSMN NewsFeed - 11 Feb 2011
Orthovita Receives FDA Clearance for Vitoss(TM) Bimodal Bone Graft Substitute
Devices Orthopaedic Regenerative Medicine FDA
 HSMN NewsFeed - 10 Feb 2011
Covidien Receives FDA Approval for Fentanyl Transdermal System Patch
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 9 Feb 2011
Neuralstem Receives FDA Orphan Designation for Spinal Cord Stem Cells for Treatment of ALS
Biopharmaceuticals Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 9 Feb 2011
EOS imaging receives additional FDA clearance of its sterEOS workstation for 3D orthopedic imaging of lower limb disorders and deformities
Devices Radiology Orthopaedic FDA
 HSMN NewsFeed - 9 Feb 2011
RepRegen(TM) seeks US FDA 510(k) clearance for StronBone(TM)
Devices Orthopaedic Regenerative Medicine FDA
 HSMN NewsFeed - 9 Feb 2011
Rcadia COR Analyzer System Receives Expanded FDA Clearance to Rule Out Coronary Artery Disease in Coronary Branch Vessels
Devices Cardiology Radiology FDA
 HSMN NewsFeed - 8 Feb 2011
Medtronic Receives FDA Approval for First and Only Pacemaker System in the U.S. Designed for Use in the MRI Environment
Devices Cardiology Radiology FDA
 HSMN NewsFeed - 8 Feb 2011
Pervasis Receives FDA Fast Track Status for Vascugel(R) to Prevent Arteriovenous Access Failure in Patients Undergoing Hemodialysis
Biopharmaceuticals Interventional FDA
 HSMN NewsFeed - 8 Feb 2011
miraDry by Miramar Labs Receives FDA 510(k) Clearance
Devices Dermatology FDA
 HSMN NewsFeed - 8 Feb 2011
Oculus Innovative Sciences Receives New FDA 510(k) Clearance for Microcyn-Based Dermatology HydroGel for Management of Atopic Dermatitis, Radiation Dermatitis and Other Skin Dermatoses
Devices Dermatology FDA
 HSMN NewsFeed - 7 Feb 2011
PCI Receives FDA 510(k) Clearance for On-Site Oxygen Generators
Devices FDA
 HSMN NewsFeed - 7 Feb 2011
FDA Approves Labeling Update for REYATAZ(R) (atazanavir sulfate) Capsules to Include Data Supporting the Recommended Adult Dose of REYATAZ/ritonavir 300/100 mg for HIV-1 Infected Pregnant Women
Biopharmaceuticals HIV/AIDS FDA
 HSMN NewsFeed - 7 Feb 2011
Ornim, Inc. Announces FDA Clearance for Non-Invasive Brain Oximetry and Blood Flow Monitoring
Devices Monitoring Neurology FDA
 HSMN NewsFeed - 4 Feb 2011
FDA Approves Makena, the First and Only Treatment to Reduce the Risk of Preterm Birth in Women With a Singleton Pregnancy Who Have a History of Singleton Spontaneous Preterm Birth
Biopharmaceuticals FDA
 HSMN NewsFeed - 4 Feb 2011
FDA Grants Orphan Drug Designation to Bayer's Investigational Compound Regorafenib for the Treatment of Gastrointestinal Stromal Tumors
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 3 Feb 2011
FDA Clears First Patient-Specific Implant System for Total Knee Replacement
Devices Orthopaedic Personalized Medicine FDA
 HSMN NewsFeed - 2 Feb 2011
FSS Receives Full Investigational Device Exemption (IDE) Approval for its FlexStent(R) Stent System
Devices Interventional FDA
 HSMN NewsFeed - 1 Feb 2011
Cyberonics Announces FDA Approval of Aspire High Capacity Generator for VNS Therapy
Devices FDA
 HSMN NewsFeed - 1 Feb 2011
FDA Issues Complete Response to New Drug Application for Contrave(R) for the Management of Obesity
Biopharmaceuticals FDA
 HSMN NewsFeed - 31 Jan 2011
BioMimetic Therapeutics Announces Date of FDA Advisory Panel Review of Augment(TM) Bone Graft
Devices Regenerative Medicine Orthopaedic FDA
 HSMN NewsFeed - 31 Jan 2011
Abbott's TREK(R) Coronary Balloon System Now Available in the United States and Japan
Devices Interventional Cardiology Regulatory FDA
 HSMN NewsFeed - 31 Jan 2011
Boston Scientific Announces FDA Approval of Renegade(R) HI-FLO Fathom(R) Pre-Loaded System
Devices Interventional Drug Delivery Oncology FDA
 HSMN NewsFeed - 31 Jan 2011
Osyris Medical Receives FDA 510(K) For LIPOCONTROL(TM) Laser Assisted Lipolysis System
Devices FDA
 HSMN NewsFeed - 28 Jan 2011
Mylan Receives Approval for First-to-File Generic Sular(R) Extended-Release Tablets
Biopharmaceuticals Cardiology Generics FDA
 HSMN NewsFeed - 27 Jan 2011
REMOXY New Drug Application Accepted by FDA
Biopharmaceuticals Pain Management
 HSMN NewsFeed - 26 Jan 2011
Corindus Vascular Robotics Announces FDA Conditional Approval for Pivotal Study to Evaluate Robotic-Assisted Placement of Coronary Guidewires and Stent/Balloon Catheters
Devices Interventional Cardiology
 HSMN NewsFeed - 26 Jan 2011
U.S. FDA Approves Number One U.S.-Prescribed Allergy Treatment Allegra for Over-The-Counter Use
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Jan 2011
Bristol-Myers Squibb and sanofi-aventis Announce U.S. FDA Decision to Grant Pediatric Exclusivity For PLAVIX
Biopharmaceuticals Cardiology Generics FDA
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