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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: Regulatory

 HSMN NewsFeed - 20 Nov 2018
OrthoXel(TM) Orthopaedic Trauma Device Company Announce CE Mark Clearance Following FDA 510(k) for new Apex Femoral Nailing System
Devices Orthopaedic Regulatory
 HSMN NewsFeed - 20 Nov 2018
E-Motion Medical Receives CE Mark Approval for Its Novel Stimulation Therapy for Patients With Acute Digestive Dysmotility
Devices Gastroenterology Regulatory
 HSMN NewsFeed - 19 Nov 2018
Philips Debuts Noninvasive Ventilator With High Flow Therapy to Improve Patient Care
Devices Regulatory Product Launch
 HSMN NewsFeed - 16 Nov 2018
Edwards' SAPIEN 3 Ultra Transcatheter Heart Valve Receives CE Mark
Devices Interventional Cardiology Regulatory
 HSMN NewsFeed - 15 Nov 2018
New Approvals Allow Chronic Pain Sufferers to Try Abbott's Non-Opioid Pain Therapy Before Getting Device Implant
Devices Neurology FDA Regulatory Product Launch
 HSMN NewsFeed - 9 Nov 2018
Jazz Pharmaceuticals Submits Marketing Authorization Application to European Medicines Agency for Solriamfetol as a Treatment to Improve Wakefulness and Reduce Excessive Daytime Sleepiness in Adult Patients with Narcolepsy or Obstructive Sleep Apnea
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 5 Nov 2018
EMA Validates and Grants Accelerated Assessment of Marketing Authorization Application for Daiichi Sankyo's FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 2 Nov 2018
TempTraq(R) Wearable Temperature Monitoring Patch Earns CE Mark Approval
Devices Monitoring Regulatory
 HSMN NewsFeed - 1 Nov 2018
AbbVie Receives European Commission Approval of VENCLYXTO(R) (venetoclax) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 23 Oct 2018
BioGX Launches 5 new CE Mark IVD Tests, Expands Sexual Health Panels on the BD MAX(TM)
Diagnostics Regulatory Product Launch
 HSMN NewsFeed - 19 Oct 2018
Mylan and Biocon Announce Positive CHMP Opinion for Ogivri(R), Biosimilar Trastuzumab
Biopharmaceuticals Generics Oncology Regulatory
 HSMN NewsFeed - 17 Oct 2018
Adam Hacker, PhD Joins Autolus as Senior Vice President for Regulatory Affairs and Quality
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 17 Oct 2018
Thermo Fisher Scientific CE Marks Oncomine Dx Target Test
Diagnostics Oncology Regulatory
 HSMN NewsFeed - 15 Oct 2018
CIVCO Radiotherapy Announces FDA 510k Clearance and CE Mark of their Solstice SRS Immobilization System
Devices Oncology FDA Regulatory
 HSMN NewsFeed - 11 Oct 2018
Rigel Receives EMA Validation of the Marketing Authorization Application for Fostamatinib Disodium Hexahydrate in Chronic Immune Thrombocytopenia (ITP) in Adult Patients
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 10 Oct 2018
OSE Immunotherapeutics and Oncology Physician Network GERCOR Announce Submission of Investigational New Drug Application to Evaluate Tedopi(R) in Combination with Nivolumab in Pancreatic Cancer
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 3 Oct 2018
SI-BONE, Inc. Announces that NICE, the UK National Institute for Health and Care Excellence, Published Medical Technology Guidance Finding that the Evidence Supports Treatment of Sacroiliac Joint Pain with the iFuse Implant System(R)
Devices Orthopaedic Neurosurgery Regulatory
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