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Healthcare News Roundup: FDA

 HSMN NewsFeed - 22 Jan 2013
ARROW(R) UltraQuik(TM) Peripheral Nerve Block Needles Receive FDA 510(k) Clearance
Devices FDA
 HSMN NewsFeed - 21 Jan 2013
Mallinckrodt Announces Approval of New Gablofen(R) Prefilled Syringe
Biopharmaceuticals Drug Delivery Neurology FDA
 HSMN NewsFeed - 17 Jan 2013
Sanovas Files for FDA Clearance of Vas Zeppelin(TM) Smart Catheter(TM)
Devices Interventional FDA
 HSMN NewsFeed - 16 Jan 2013
InfraScan Receives FDA Approval of Next Generation, Noninvasive Handheld Brain Hematoma Detector
Devices Neurosurgery FDA
 HSMN NewsFeed - 15 Jan 2013
FDA Clears Apira Science's iGrow(R) Hair Growth Platform
Devices FDA
 HSMN NewsFeed - 15 Jan 2013
Rex Medical Cleaner15 Rotational Thrombectomy System Receives 510(k) Clearance
Devices Interventional Distribution FDA
 HSMN NewsFeed - 14 Jan 2013
Neuralstem Receives FDA Approval To Commence Spinal Cord Injury Trial
Biopharmaceuticals Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 14 Jan 2013
Gore Receives FDA Approval for New GORE(R) EXCLUDER(R) AAA Endoprosthesis Components
Devices Interventional FDA
 HSMN NewsFeed - 14 Jan 2013
Hologic Announces FDA Clearance of APTIMA Trichomonas for Use on PANTHER System
Diagnostics FDA
 HSMN NewsFeed - 10 Jan 2013
FDA Drug Safety Communication: Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist)
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 Jan 2013
Brainsway Receives FDA Approval
Devices Neurology FDA
 HSMN NewsFeed - 9 Jan 2013
FDA Clears Software That Helps Radiologists Rapidly and Accurately Confirm Placement of Lifesaving Medical Devices
Devices Radiology FDA
 HSMN NewsFeed - 8 Jan 2013
InnoPharma, Inc. Announces U.S. FDA Approval of Acetylcysteine Injection
Biopharmaceuticals Distribution FDA
 HSMN NewsFeed - 7 Jan 2013
Thoratec Announces FDA Approval To Commence REVIVE-IT Study Utilizing HeartMate II
Devices Cardiology FDA
 HSMN NewsFeed - 3 Jan 2013
Tensys Medical Receives US FDA 510(k) for TL-300, Latest Generation in Continuous, Non-Invasive Hemodynamic Patient Monitoring System
Devices Monitoring Cardiology FDA
 HSMN NewsFeed - 3 Jan 2013
Alphatec Spine Receives U.S. FDA 510(K) Market Clearance for Two New Products and Receives Japanese Shonin Approval to Begin Marketing Its Novel(R) Peek Lumbar Spinal Spacers
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 2 Jan 2013
FDA Grants Soligenix Orphan Drug Designation for OrbeShield(TM) for Treatment after Exposure to a Radiological Disaster
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Jan 2013
FDA Approves Fulyzaq(TM) (Crofelemer) 125 mg Delayed-Release Tablets for the Symptomatic Relief of Diarrhea in Patients with HIV/AIDS on Anti-Retroviral Therapy (ART)
Biopharmaceuticals FDA HIV/AIDS
 HSMN NewsFeed - 31 Dec 2012
FDA Grants Accelerated Approval for SIRTURO(TM) (bedaquiline) as Part of Combination Therapy to Treat Adults with Pulmonary Multi-Drug Resistant Tuberculosis
Biopharmaceuticals FDA
 HSMN NewsFeed - 31 Dec 2012
Medical Modeling Receives FDA 510(k) Clearance for VSP(R) (Virtual Surgical Planning) System
Devices Surgery FDA
 HSMN NewsFeed - 29 Dec 2012
Bristol-Myers Squibb and Pfizer Announce U.S. FDA Approval of ELIQUIS(R) (apixaban)
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 21 Dec 2012
FDA Approves Gattex(R) (teduglutide [rDNA Origin]) for Injection for the Treatment of Adult Short Bowel Syndrome
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 20 Dec 2012
Angiotech Receives FDA Approval for its Proprietary Bio-Seal(TM) Lung Biopsy Device
Devices Surgery Oncology FDA
 HSMN NewsFeed - 19 Dec 2012
First U.S. Patient Treated Following FDA Approval of Cook Medical’s First-of-its-Kind Zilver(R) PTX(R) Drug-Eluting Peripheral Stent
Devices Interventional
 HSMN NewsFeed - 18 Dec 2012
Avinger Receives FDA Clearance for Ocelot / PIXL
Devices Interventional FDA
 HSMN NewsFeed - 18 Dec 2012
Mylan Launches Generic Version of Qualaquin(R) Capsules
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 18 Dec 2012
FDA Clears IND For First Clinical Trial Protocol Developed Using Crowdsourcing
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 17 Dec 2012
Andrew Technologies Receives FDA 510(k) Clearance for Commercial Version of HydraSolve(TM) Lipoplasty System
Devices Surgery FDA
 HSMN NewsFeed - 17 Dec 2012
Lexicon's Drug Candidate For Irritable Bowel Syndrome Receives Fast Track Status From The FDA
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 17 Dec 2012
Elekta: New Clarity Soft Tissue Visualization Software Neutralizes Organ Motion Challenges During Prostate Cancer Radiotherapy
Devices Oncology FDA
 HSMN NewsFeed - 14 Dec 2012
Next-Generation OmniPod(R) Insulin Pump Cleared by FDA
Devices Drug Delivery Endocrinology FDA
 HSMN NewsFeed - 14 Dec 2012
InVivo Therapeutics Requests Humanitarian Use Device Designation with FDA
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 13 Dec 2012
MAQUET Cardiovascular Announces U.S. Food and Drug Administration Panel Votes To Reclassify Intra-Aortic Balloon Pumps To A Class II Designation In Certain Indications
Devices Cardiology FDA
 HSMN NewsFeed - 12 Dec 2012
Natus Comments on FDA Recall
Devices Product Recall FDA
 HSMN NewsFeed - 12 Dec 2012
Sucampo Announces FDA Approval of an sNDA for RESCULA(R) (unoprostone isopropyl)
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 11 Dec 2012
Diffusion Pharmaceuticals Receives FDA Orphan Designation for TSC, a First-in-Class Drug for the Treatment of Metastatic Brain Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 10 Dec 2012
Blue Belt Technologies Receives FDA Clearance to Market its NavioPFS Surgical System for Unicondylar Knee Replacement Surgery
Devices Orthopaedic FDA
 HSMN NewsFeed - 10 Dec 2012
Merit Medical Announces 510(k) Clearance for the ONE Snare(TM) System
Devices Interventional FDA
 HSMN NewsFeed - 10 Dec 2012
LENSAR Laser System(TM) Receives FDA Clearance for Corneal Incisions in Cataract Surgery
Devices Ophthalmology FDA
 HSMN NewsFeed - 7 Dec 2012
FDA Approves EVARREST(TM) Fibrin Sealant Patch
Devices Surgery FDA
 HSMN NewsFeed - 4 Dec 2012
Biosign Technologies Receives FDA Pre-market Clearance for Biosign Pulsewave(TM) Monitor
Devices Cardiology Monitoring FDA
 HSMN NewsFeed - 3 Dec 2012
AliveCor’s Heart Monitor for iPhone Receives FDA Clearance
Devices Cardiology Monitoring FDA
 HSMN NewsFeed - 29 Nov 2012
NeuroMetrix Completes 510(k) Clearance Process for SENSUS(TM) Pain Management System
Devices Endocrinology Neurology FDA
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