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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 - 19 Oct 2017
Kent Imaging Revolutionizes Perfusion Imaging with their FDA-Cleared KD203
Devices Wound Care FDA
 HSMN NewsFeed - 16 Oct 2017
NuVasive Receives Expanded FDA 510(k) Clearance For TLX Interbody System Used In TLIF Procedures
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 13 Oct 2017
Philips Receives U.S. FDA 510(K) Clearance to Market its Solution for 'Small Parts' Ultrasound Imaging
Devices Radiology FDA
 HSMN NewsFeed - 12 Oct 2017
FDA Clears First 7T Magnetic Resonance Imaging Device
Devices Radiology FDA
 HSMN NewsFeed - 12 Oct 2017
NuVasive Receives Expanded FDA 510(k) Clearance For Innovative Magnetic Limb Lengthening Technology
Devices Orthopaedic FDA
 HSMN NewsFeed - 12 Oct 2017
FDA Grants Priority Review for Potential New Indication for Lilly's Verzenio(TM) (abemaciclib) as Initial Treatment of Advanced Breast Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 11 Oct 2017
Janssen Submits New Drug Application to U.S. FDA for Apalutamide (ARN-509) to Treat Men with Non-Metastatic Castration-Resistant Prostate Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 10 Oct 2017
Respicardia's remedē(R) System Receives FDA Approval
Devices Neurology FDA
 HSMN NewsFeed - 10 Oct 2017
Allergan Announces that the FDA Accepts New Drug Application for Ulipristal Acetate for Uterine Fibroids
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Oct 2017
Game Ready(R) Receives FDA 510(k) Clearance For Med4 Elite(TM) Multi-Modality Recovery Device
Devices Orthopaedic FDA
 HSMN NewsFeed - 5 Oct 2017
Cepheid Expands Respiratory Disease Portfolio with Xpert Xpress Strep A
Diagnostics FDA
 HSMN NewsFeed - 5 Oct 2017
Neurocrine Announces FDA Approval of 80 mg INGREZZA(R) (valbenazine) Capsules for the Treatment of Adults with Tardive Dyskinesia (TD)
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 4 Oct 2017
Solta Medical Receives FDA 510(k) Clearance for Thermage FLX(TM) System, Newest Generation Skin Smoothing Technology
Devices Dermatology FDA
 HSMN NewsFeed - 3 Oct 2017
DiscGenics Receives FDA Allowance of IND to Commence Clinical Study of Its Degenerative Disc Disease Therapy
Devices Regenerative Medicine Orthopaedic FDA
 HSMN NewsFeed - 2 Oct 2017
Alere Receives FDA Clearance for Alere(TM) i Influenza A & B 2 Rapid Molecular Test
Diagnostics FDA
 HSMN NewsFeed - 28 Sep 2017
EOI Announces FDA Clearance for the FLXfit15, the Only 3D Articulated Expandable Cage With 15 degrees of Lordosis Correction
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 27 Sep 2017
Hologic Receives FDA 510(k) Clearance to Market SculpSure(R) for Non-Invasive Body Contouring (Lipolysis) of the Submental Area (Under the Chin)
Devices Dermatology FDA Product Launch
 HSMN NewsFeed - 26 Sep 2017
Spiral Therapeutics Receives Positive IND Submission Guidance from FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Sep 2017
Mortise Medical Receives FDA Clearance for LigaMetrics(TM) Suture Anchor System
Devices Surgery FDA
 HSMN NewsFeed - 25 Sep 2017
Bracco Diagnostics Inc. Receives U.S. FDA Approval for TAGITOL(TM) V (Barium Sulfate) Oral Suspension
Biopharmaceuticals Radiology FDA
 HSMN NewsFeed - 25 Sep 2017
Boston Scientific Announces U.S. FDA Approval for MRI Labeling on High-Voltage Devices and U.S. Launch of Resonate(TM) Devices with the HeartLogic(TM) Heart Failure Diagnostic
Devices Cardiology FDA
 HSMN NewsFeed - 25 Sep 2017
Lannett's Board Of Directors Initiates CEO Search
Biopharmaceuticals Generics Personnel FDA
 HSMN NewsFeed - 22 Sep 2017
Abbott Secures FDA Approval for MRI-Compatibility for the Company's Ellipse(TM) ICD
Devices Cardiology FDA
 HSMN NewsFeed - 21 Sep 2017
ManaMed Inc. Introduces PlasmaFlow, The World's First FDA-Approved Digital and Tubeless Deep Vein Thrombosis Prevention Device
Devices Product Launch
 HSMN NewsFeed - 21 Sep 2017
FDA Releases Cefaly(R) for Acute Treatment of Migraine Attacks
Devices Neurology FDA
 HSMN NewsFeed - 18 Sep 2017
ARKRAY launches ADAMS(TM) A1c HA-8180V System for hemoglobin A1c testing
Diagnostics FDA Product Launch
 HSMN NewsFeed - 15 Sep 2017
New indication for BRIVIACT(R) (brivaracetam): UCB's newest antiepileptic drug approved by FDA as monotherapy treatment of partial-onset seizures in adults
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 12 Sep 2017
T.R.U.E. Test(R) Ready-To-Use Patch Test Receives FDA Approval For Pediatric Use
Diagnostics Dermatology FDA
 HSMN NewsFeed - 12 Sep 2017
Aethlon Medical Receives Expedited Access Pathway Designation from FDA to Accelerate U.S. Access to the Hemopurifier(R) as a Treatment for Life-Threatening Viruses
Devices FDA
 HSMN NewsFeed - 8 Sep 2017
Regeneron and Sanofi Announce Cemiplimab (REGN2810) Has Received FDA Breakthrough Therapy Designation for Advanced Cutaneous Squamous Cell Carcinoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 7 Sep 2017
eNeura, Inc. Receives FDA Clearance for Use of SpringTMS(R) for Migraine Prevention
Devices Neurology FDA
 HSMN NewsFeed - 7 Sep 2017
Spinal Resources, Inc.'s Swedge Pedicle Screw System Receives FDA 510(k) Clearance
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 7 Sep 2017
MiMedx Notified By FDA That It Can Proceed With Phase 3 Investigational New Drug Clinical Trial For Achilles Tendonitis
Biopharmaceuticals Regenerative Medicine Orthopaedic FDA
 HSMN NewsFeed - 6 Sep 2017
NeuroRx Awarded FDA Fast Track Designation for First Drug Regimen Targeting Suicide in Bipolar Depression
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Sep 2017
AbbVie Submits New Drug Application to U.S. FDA for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Sep 2017
Actelion Receives FDA Approval Of TRACLEER(R) (bosentan) For Use In Pediatric Patients With Pulmonary Arterial Hypertension
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 Sep 2017
Eiger Announces FDA Orphan Drug Designation Granted for Pegylated Interferon Lambda in Hepatitis Delta Virus Infection
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 Sep 2017
FDA Grants Orphan Drug Status to Cellect's ApoGraft(TM) for Acute GvHD and Chronic GvHD
Regenerative Medicine FDA
 HSMN NewsFeed - 1 Sep 2017
FDA approves Mylotarg for treatment of acute myeloid leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 1 Sep 2017
ANI Pharmaceuticals Announces Approval and Launch of Oxycodone Hydrochloride Oral Solution, 100 mg/5mL
Biopharmaceuticals Generics FDA Product Launch
 HSMN NewsFeed - 31 Aug 2017
U.S. FDA Approves Chemo Group's Benznidazole to Treat Children with Chagas Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 31 Aug 2017
CSA Medical Announces Expansion of truFreeze(R) Label to Include Barrett's Esophagus with Low Grade Dysplasia
Devices Interventional FDA
 HSMN NewsFeed - 29 Aug 2017
FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo's DS-8201 for HER2-Positive Metastatic Breast Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 29 Aug 2017
Sorrento Therapeutics, Inc. Submits NDA For ZTlido(TM) Next-Generation Lidocaine Patch
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 29 Aug 2017
Leica FL560 achieves First FDA Clearance for cerebrovascular fluorescence with fluorescein
Devices Neurosurgery FDA
 HSMN NewsFeed - 28 Aug 2017
Abbott Introduces HeartMate 3 Left Ventricular Assist System - the Latest Milestone In Therapy For Advanced Heart Failure Patients
Devices Cardiology FDA Product Launch
 HSMN NewsFeed - 28 Aug 2017
NxStage Medical Announces FDA Clearance for Solo Home Hemodialysis Using NxStage(R) System One(TM)
Devices FDA
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