Healthcare Sales & Marketing Network News: FDA

Healthcare News Roundup: FDA

HSMN NewsFeed - 16 Apr 2021
Lilly requests revocation of emergency use authorization for bamlanivimab alone to complete transition to bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.
Biopharmaceuticals 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 - 8 Apr 2021
Crown Aesthetics Proudly Announces New Indication For Treatment Of Neck Wrinkles For FDA-Cleared Microneedling System, SkinPen(R) Precision
Devices Dermatology 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 - 6 Apr 2021
nanoMesh(TM) LLC (a subsidiary of Exogenesis Corporation) Announces Completion Filing of a Second Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA)
Devices Surgery 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 - 31 Mar 2021
CTI BioPharma Announces Completion of Rolling Submission of New Drug Application (NDA) for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia
Biopharmaceuticals FDA

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
Revolutionary Option for Medical Device Sterilization Approved by FDA
Devices 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
Subtle Medical Launches SubtleMR(TM) 2.0 to Expand Improved MRI Capabilities
Devices Radiology FDA Product Launch

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 - 5 Mar 2021
Elekta and IBA strengthen partnership to help cancer centers integrate proton therapy
Devices Oncology 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

HSMN NewsFeed - 24 Feb 2021
G21(R) announces the FDA Clearance of SpaceFlex Shoulder(TM) : The unique complete line of Custom Modular Spacers available worldwide
Devices Orthopaedic FDA

HSMN NewsFeed - 23 Feb 2021
Elicio Therapeutics Announces FDA Clearance of IND application for ELI-002-- A Therapeutic Vaccine Targeting mutated KRAS Cancers
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 22 Feb 2021
Piccolo Medical Receives U.S. FDA Clearance of its SmartPICC(TM) System for the positioning of Peripherally Inserted Central Catheters
Devices FDA

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