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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 - 22 Apr 2021
Getinge receives US FDA 510(k) clearance for three products, expanding the Servo ventilator platform
Devices FDA
 HSMN NewsFeed - 21 Apr 2021
Medtronic Receives U.S. FDA Approval for Pipeline(TM) Flex Embolization Device with Shield Technology(TM)
Devices Interventional FDA
 HSMN NewsFeed - 21 Apr 2021
Cerus Endovascular Announces IDE Approval from the U.S. FDA to Conduct Clinical Study of the Contour Neurovascular System(TM)
Devices Interventional Neurosurgery FDA
 HSMN NewsFeed - 21 Apr 2021
Johnson & Johnson Vision Receives FDA Clearance and CE Mark for Next-Generation Phacoemulsification Machine, VERITAS(TM) Vision System
Devices Ophthalmology FDA Regulatory
 HSMN NewsFeed - 20 Apr 2021
Zimmer Biomet Receives FDA Clearance for ROSA(R) Partial Knee System for Robotically-Assisted Partial Knee Arthroplasty
Devices Orthopaedic FDA
 HSMN NewsFeed - 19 Apr 2021
Curis Receives FDA Orphan Drug Designation for CA-4948 for the Treatment of AML and MDS
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 12 Apr 2021
U.S. FDA Grants De Novo Clearance for First and Only Artificial Intelligence System for Colonoscopy; Medtronic Launches GI Genius(TM) Intelligent Endoscopy Module
Devices Gastroenterology FDA Product Launch
 HSMN NewsFeed - 12 Apr 2021
Cosmo announces FDA approval of GI Genius(TM) intelligent endoscopy module, its revolutionary Artificial Intelligence device for lesion detection during colonoscopy
Devices Gastroenterology FDA
 HSMN NewsFeed - 9 Apr 2021
Activ Surgical Announces FDA Clearance for ActivSight Intraoperative Imaging Module for Enhanced Surgical Visualization
Devices Surgery FDA
 HSMN NewsFeed - 7 Apr 2021
Chemence Medical Receives FDA Approval for Exofin Fusion(R) Redesign
Devices Surgery FDA
 HSMN NewsFeed - 7 Apr 2021
FDA Approves Bausch & Lomb ClearVisc(TM) Dispersive Ophthalmic Viscosurgical Device
Devices Ophthalmology FDA
 HSMN NewsFeed - 5 Apr 2021
IceCure Medical Granted FDA Breakthrough Device Designation for ProSense(R) Cryoablation System
Devices Oncology FDA
 HSMN NewsFeed - 1 Apr 2021
FDA Grants Breakthrough Therapy Designation for Taiho Oncology's Futibatinib for Treatment of Advanced Cholangiocarcinoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 1 Apr 2021
United Therapeutics Announces FDA Approval and Launch of Tyvaso(R) for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease
Biopharmaceuticals FDA Product Launch
 HSMN NewsFeed - 30 Mar 2021
Biom Therapeutics Receives Orphan Drug Status for BIO017 from the U.S. FDA for the treatment of Angelman Syndrome
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 22 Mar 2021
Oakrum Pharma and Aucta Pharma Announce U.S. FDA Approval of Generic Version of JADENU(R) Sprinkle (Deferasirox Granules)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 18 Mar 2021
Boston Scientific Receives FDA Approval for TheraSphere(TM) Y-90 Glass Microspheres
Devices Oncology FDA
 HSMN NewsFeed - 16 Mar 2021
Imbio Receives FDA 510(k) Clearance for New Cardiothoracic Imaging Algorithm
Devices Cardiology Radiology FDA
 HSMN NewsFeed - 15 Mar 2021
Check-Cap Receives FDA IDE Approval for Pivotal Study of C-Scan(R)
Devices Gastroenterology FDA
 HSMN NewsFeed - 11 Mar 2021
Qardio Announces FDA Clearance for QardioCore, a self-fit continuous ambulatory ECG to view and annotate ECG
Devices Cardiology Monitoring FDA
 HSMN NewsFeed - 11 Mar 2021
Alkermes Announces FDA Orphan Drug Designation for Nemvaleukin Alfa for Treatment of Mucosal Melanoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 10 Mar 2021
Luminex Submits Joint SARS-CoV-2 and Flu/RSV Respiratory Panel to FDA for Emergency Use Authorization
Diagnostics FDA
 HSMN NewsFeed - 9 Mar 2021
Roche receives FDA approval for VENTANA ALK (D5F3) CDx Assay to identify lung cancer patients eligible for targeted treatment with LORBRENA (lorlatinib)
Diagnostics Oncology FDA
 HSMN NewsFeed - 8 Mar 2021
BioMarin Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to Valoctocogene Roxaparvovec, Investigational Gene Therapy for Hemophilia A
Biopharmaceuticals FDA
 HSMN NewsFeed - 4 Mar 2021
ControlRad(R) Announces FDA Clearance for ControlRad Select
Devices Interventional FDA Distribution
 HSMN NewsFeed - 4 Mar 2021
MedAlliance Receives Fourth FDA Breakthrough Device Designation for Sirolimus Drug-Eluting Balloon in Treatment of De Novo Coronary Lesions
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 4 Mar 2021
Luminex Receives FDA Emergency Use Authorization and CE Mark for Expanded NxTAG(R) Respiratory Panel Test Including SARS-CoV-2
Diagnostics FDA Regulatory
 HSMN NewsFeed - 3 Mar 2021
Creative Medical Technology Holdings Provides Update on ImmCelz(R) FDA Application
Regenerative Medicine FDA
 HSMN NewsFeed - 1 Mar 2021
Vascular Graft Solutions Wins FDA approval to Market the VIOLA(TM) Clampless Proximal Anastomosis System for CABG
Devices Cardiology Surgery FDA
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