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

Healthcare News Roundup: 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 - 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
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 - 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
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 - 27 Nov 2012
Given Imaging Submits PillCam(R) COLON 2 Application to FDA for U.S. Regulatory Clearance
Devices Gastroenterology FDA

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