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The Healthcare Sales & Marketing Network celebrates 28 years serving the medical sales & marketing community.Connecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product LinesConnecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product Lines

Healthcare News Roundup: FDA

 HSMN NewsFeed - 12 Jun 2012
Tokai Pharmaceuticals’ Galeterone Receives Fast Track Designation from the FDA for the Treatment of Advanced Prostate Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 12 Jun 2012
ETView Medical, Ltd. Announces US FDA Clearance of a 510(k) Pre-Marketing Notification Application for the Viva(TM) EB Line of Innovative Endobronchial Blockers
Devices Surgery FDA
 HSMN NewsFeed - 12 Jun 2012
Toshiba’s Encore VeloCT Console Receives FDA Clearance
Devices Radiology FDA
 HSMN NewsFeed - 12 Jun 2012
Genzyme Submits Applications to FDA and EMA for Approval of LEMTRADA(TM) (alemtuzumab) for Multiple Sclerosis
Biopharmaceuticals Neurology FDA Regulatory
 HSMN NewsFeed - 11 Jun 2012
Mevion Medical Systems Announces FDA 510(k) Clearance for the MEVION S250 Proton Therapy System
Devices Oncology FDA
 HSMN NewsFeed - 11 Jun 2012
Nexstim Announces FDA Clearance for NexSpeech(R) – Enabling Noninvasive Speech Mapping Prior to Neurosurgery
Devices Neurosurgery
 HSMN NewsFeed - 7 Jun 2012
GSK and XenoPort Receive FDA Approval for Horizant(R) for Postherpetic Neuralgia
Biopharmaceuticals FDA
 HSMN NewsFeed - 4 Jun 2012
FDA Clears Erchonia’s Zerona Laser for the Non-Invasive Reduction of the Arms
Devices FDA
 HSMN NewsFeed - 4 Jun 2012
Boston Scientific Receives FDA Approval for 32 MM and 38 MM Lengths for PROMUS Element(TM) Plus Platinum Chromium Stent System
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 30 May 2012
Teleflex Receives FDA 510(k) Clearance for ARROW(R) FlexTip Plus(R) Closed Tip, Multi-Port Epidural Catheter
Devices FDA
 HSMN NewsFeed - 24 May 2012
SRS Endoscopic System Receives FDA Clearance for Treatment of Gastroesophageal Reflux Disease (GERD)
Devices Gastroenterology FDA
 HSMN NewsFeed - 24 May 2012
Cepheid Receives FDA Clearance for GeneXpert Infinity-80 System for Initial Use with Xpert Flu Assay
Diagnostics FDA
 HSMN NewsFeed - 23 May 2012
CardioComm Solutions Receives FDA Clearance for Prescription Use of the HeartCheck(TM) ECG PEN
Devices Cardiology FDA
 HSMN NewsFeed - 23 May 2012
ETView Medical, Ltd. Announces US FDA Clearance of a 510(k) Pre-Marketing Notification Application for the VivaSight(TM)-DL line of Innovative Airway Devices
Devices FDA
 HSMN NewsFeed - 23 May 2012
TriReme Medical, Inc. Receives FDA Approval for Glider(TM) PTCA Catheter
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 22 May 2012
ActiViews, Inc. Announces SFDA Clearance for CT-Guide(TM) Needle Guidance System in China
Devices Interventional Radiology Regulatory
 HSMN NewsFeed - 22 May 2012
FDA Approves Levemir(R) for Expanded Use in Children Two to Five Years of Age with Type 1 Diabetes
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 18 May 2012
ApniCure Receives FDA 510(k) Clearance to Market Winx(TM) Sleep Therapy System for Treatment of Obstructive Sleep Apnea
Devices FDA
 HSMN NewsFeed - 15 May 2012
Covalon Announces Major Milestone: Achieves FDA Approval for IV Clear(TM) - a Breakthrough Antimicrobial Silicone Adhesive Film Dressing for Securing Vascular Access Medical Devices
Devices FDA
 HSMN NewsFeed - 14 May 2012
Bioness Announces FDA Clearance of Smaller Leg Cuff for Use with Its L300 Foot Drop System
Devices Neurology FDA
 HSMN NewsFeed - 14 May 2012
FDA Grants Fast Track Designation to Ohr Pharmaceutical's Squalamine Eye Drops for the Treatment of Wet-AMD
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 14 May 2012
MAQUET Cardiovascular Receives FDA 510(k) Clearance For New Mega(R) Intra-Aortic Balloon Catheter Sizes
Devices Cardiology FDA
 HSMN NewsFeed - 11 May 2012
Ampio Pharmaceuticals Reports Pre-IND Meeting With the FDA to Obtain Clinical Path Guidance for Ampion(TM) for the Treatment of Chronic Pain of Osteoarthritis of the Knee and Schedules May 16th Webcast to Update Shareholders
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 May 2012
FDA Approves BIOTRONIK Next Generation ICDs and CRT-Ds
Devices Cardiology FDA
 HSMN NewsFeed - 10 May 2012
Interrad Medical Announces FDA Clearance for Additional Sizes of the SecurAcath Device
Devices FDA
 HSMN NewsFeed - 10 May 2012
Sorin Group Announces FDA Approval and Commercial Launch of Complete Portfolio of Implantable Heart Device Leads
Devices Cardiology FDA
 HSMN NewsFeed - 9 May 2012
Janssen Research & Development Submits Supplemental New Drug Application to U.S. FDA for XARELTO(R) (rivaroxaban) to Reduce the Risk of Stent Thrombosis in Patients with Acute Coronary Syndrome
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 9 May 2012
St. Jude Medical Announces FDA Approval of Smaller ICD with Physician-Inspired Shape
Devices Cardiology FDA
 HSMN NewsFeed - 8 May 2012
FDA Clears Gen-Probe's PANTHER(R) System for use with APTIMA Combo 2(R) Assay
Diagnostics FDA
 HSMN NewsFeed - 8 May 2012
SANUWAVE Receives Conditional Approval from the FDA on Clinical Trial Plan for dermaPACE
Devices Wound Care FDA
 HSMN NewsFeed - 8 May 2012
St. Jude Medical Announces FDA Approval of Assura(TM) Implantable Defibrillators with Features that Reduce Inappropriate Shocks
Devices Cardiology FDA
 HSMN NewsFeed - 7 May 2012
Boston Scientific Announces FDA Approval and First U.S. Implant of New Devices To Treat Bradycardia
Devices Cardiology FDA
 HSMN NewsFeed - 7 May 2012
Kerberos to Sell FDA Cleared Rinspiration Technology
Devices Interventional Cardiology
 HSMN NewsFeed - 7 May 2012
Ventana Receives FDA Clearance for p53 (DO-7) Image Analysis and Digital Read Applications
Diagnostics FDA
 HSMN NewsFeed - 2 May 2012
Angioslide Announces FDA 510(K) Clearance of PROTEUS(TM) Below The Knee Device
Devices Interventional FDA
 HSMN NewsFeed - 1 May 2012
Pfizer And Protalix BioTherapeutics Announce FDA Approval Of ELELYSO(TM) (taliglucerase alfa) For The Treatment Of Gaucher Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Apr 2012
Toshiba’s Aquilion PRIME 80 CT System Receives FDA Clearance
Devices Radiology FDA
 HSMN NewsFeed - 26 Apr 2012
Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 26 Apr 2012
Theragenics Receives FDA Clearance to Market Galt VTI(TM) Valved Tearaway Introducer
Devices FDA
 HSMN NewsFeed - 26 Apr 2012
FDA Advisory Committee Votes in Favor of HeartWare(R) Ventricular Assist System as Bridge to Transplant for Patients With End-Stage Heart Failure
Devices Cardiology FDA
 HSMN NewsFeed - 25 Apr 2012
HeartWare Stock Trading Halted Today; FDA Advisory Committee to Review HeartWare(R) Ventricular Assist System as a Bridge to Heart Transplantation
Devices Cardiology FDA
 HSMN NewsFeed - 25 Apr 2012
Toshiba’s AIDR 3D Receives FDA Clearance
Devices Radiology FDA
 HSMN NewsFeed - 24 Apr 2012
LDR Announces FDA Clearance and Launch of the ROI-C(R) Lordotic Cervical Cage
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 20 Apr 2012
Abbott Receives U.S. FDA Clearance to Use iFS Advanced Femtosecond Laser Technology for Arcuate Incisions in Cataract Surgery
Devices Ophthalmology FDA
 HSMN NewsFeed - 19 Apr 2012
Carestream Health Receives FDA Clearance for New DRX-Revolution Mobile X-Ray System
Devices Radiology FDA
 HSMN NewsFeed - 18 Apr 2012
Sotera Wireless Reports FDA Clearance of ViSi Mobile(TM) System
Devices Monitoring FDA
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