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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 - 11 Jan 2017
SonaCare Medical Granted FDA Regulatory Clearance for Updated HIFU Prostate Tissue Ablation Device
Devices Urology FDA
 HSMN NewsFeed - 11 Jan 2017
FDA Grants VisionCare Inc. Approval to Initiate Clinical Study of the Telescope Implant in Post-Cataract Patients
Devices Ophthalmology FDA
 HSMN NewsFeed - 10 Jan 2017
ViraCyte Granted U.S. FDA Fast Track Designation for Viralym-C
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Jan 2017
Allergan Announces FDA Approval of NATRELLE INSPIRA(R) SoftTouch Breast Implants
Devices FDA
 HSMN NewsFeed - 3 Jan 2017
Marinus Pharmaceuticals Receives FDA Orphan Drug Designation for Ganaxolone to Treat Fragile X Syndrome
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 30 Dec 2016
Innocoll Receives Refusal to File Letter from U.S. FDA for XARACOLL(R) (bupivacaine HCl collagen-matrix implants) New Drug Application
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 27 Dec 2016
Nephros Receives FDA 510(k) Clearance of HydraGuard(TM) 10" UltraFilter
Devices FDA
 HSMN NewsFeed - 27 Dec 2016
Shire Announces FDA Approval of Adynovate(R) for use in Children and Surgical Settings
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Dec 2016
Alcon receives US FDA approval for AcrySof(R) IQ ReSTOR(R) +3.0D Multifocal Toric intraocular lens for cataract patients
Devices Ophthalmology FDA
 HSMN NewsFeed - 22 Dec 2016
AirXpanders Receives FDA de novo Clearance for AeroForm(R) Tissue Expander System
Devices Surgery Oncology FDA
 HSMN NewsFeed - 20 Dec 2016
Foundation Medicine Receives FDA Approval of FoundationFocus(TM) CDxBRCA as a Companion Diagnostic for Rubraca(TM) (rucaparib) for the Treatment of Women with Ovarian Cancer
Diagnostics Oncology FDA
 HSMN NewsFeed - 20 Dec 2016
Repros Requests Meeting With FDA to Discuss Phase 3 Requirements for Proellex(R) in the Treatment of Endometriosis
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Dec 2016
Masimo Announces FDA 510(k) Clearance for TFA-1(TM) Single-Patient-Use Forehead Sensor
Devices Monitoring FDA
 HSMN NewsFeed - 19 Dec 2016
AbbVie Submits New Drug Application to U.S. FDA for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes of Chronic Hepatitis C
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Dec 2016
FDA Orphan Drug Designation Granted to Profounda Inc. for the Treatment of Acanthamoeba Keratitis with Miltefosine
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 16 Dec 2016
Janssen Submits Application Seeking FDA Approval of STELARA(R) (Ustekinumab) for the Treatment of Adolescents with Moderate to Severe Plaque Psoriasis
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 16 Dec 2016
Grünenthal Receives Breakthrough Therapy Designation From U.S. FDA for Neridronic Acid for the Treatment of CRPS
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Dec 2016
Lumendi Receives FDA Clearance to Market DiLumen(TM) for Endolumenal Therapy
Devices Gastroenterology FDA
 HSMN NewsFeed - 12 Dec 2016
Galderma Announces FDA Approval of Restylane(R) Refyne and Restylane(R) Defyne Dermal Fillers for Treatment of "Laugh Lines"
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 8 Dec 2016
Advanced Accelerator Applications Announces CMS Pass-Through Reimbursement Code for its First FDA Approved Drug NETSPOT(R)
Biopharmaceuticals Radiology Oncology Reimbursement
 HSMN NewsFeed - 7 Dec 2016
Gordian Surgical Completes $2.25 Million Raise and Receives FDA Clearance for TroClose1200(TM)
Devices Surgery FDA Venture Capital
 HSMN NewsFeed - 7 Dec 2016
Neovacs obtains FDA “Fast Track” designation for IFNα Kinoid in Lupus (SLE)
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 Dec 2016
KYOCERA Medical Corporation Receives FDA 510(k) Clearance for Initia(R) Total Hip System, Featuring BIOCERAM AZUL(R) Ceramic Femoral Head
Devices Orthopaedic FDA
 HSMN NewsFeed - 2 Dec 2016
Nanowear receives FDA clearance for its transformative remote diagnostic monitoring device differentiated by novel cloth-based nanosensor technology (SimplECG(TM))
Devices Monitoring FDA
 HSMN NewsFeed - 1 Dec 2016
Helsinn Integrative Care Announces 510(K) FDA Clearance for Medical Device Xonrid(R) Gel
Devices Oncology Dermatology FDA Product Launch
 HSMN NewsFeed - 30 Nov 2016
Neurocrine Announces FDA Advisory Committee Meeting to Review INGREZZA(TM) (valbenazine) New Drug Application for the Treatment of Tardive Dyskinesia
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 29 Nov 2016
Cynosure Receives CFDA Clearance to Market the Icon(TM) Aesthetic System in China
Devices Dermatology Regulatory
 HSMN NewsFeed - 28 Nov 2016
Toshiba Medical’s Fully Integrated Model-Based Iterative CT Reconstruction Receives FDA Clearance
Devices Radiology FDA Product Launch
 HSMN NewsFeed - 22 Nov 2016
Allergan Receives FDA Clearance for the XEN(R) Gel Stent, a New Surgical Treatment for Refractory Glaucoma
Devices Ophthalmology FDA
 HSMN NewsFeed - 22 Nov 2016
DARZALEX(R) (daratumumab) Approved by U.S. FDA in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who Have Received At Least One Prior Therapy
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 21 Nov 2016
GSK Receives FDA Approval for Expanded Indication for Flulaval(R) Quadrivalent (Influenza Vaccine) for Infants 6 Months and Older
Biopharmaceuticals FDA
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