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Healthcare News Roundup: FDA

 HSMN NewsFeed - 28 Sep 2022
Harrow Announces U.S. FDA Approval of IHEEZO(TM) (Chloroprocaine Hydrochloride Ophthalmic Gel) 3% for Ocular Surface Anesthesia
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 23 Sep 2022
iSyncWave EEG Scanner Receives FDA 510k Clearance
Devices Neurology FDA
 HSMN NewsFeed - 22 Sep 2022
FDA Grants QT Imaging(TM) Clearance to Calculate Fibroglandular Volume of the Breast
Devices Oncology FDA
 HSMN NewsFeed - 21 Sep 2022
Immunitas Therapeutics Receives FDA Clearance of IND Application for IMT-009 in Solid Tumors and Hematological Malignancies
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 20 Sep 2022
Medtronic receives FDA clearance for expanded indication of LINQ II(TM) insertable cardiac monitor for use in pediatric patients ages 2 and older
Devices Cardiology Monitoring FDA
 HSMN NewsFeed - 20 Sep 2022
Zimmer Biomet Receives FDA Clearance for Identity(TM) Shoulder System for Shoulder Replacement
Devices Orthopaedic FDA
 HSMN NewsFeed - 13 Sep 2022
Ventris Medical Receives 510(k) Clearance for Amplify(R) Standalone Bone Graft Putty and Bone Graft Extender
Devices Regenerative Medicine FDA
 HSMN NewsFeed - 7 Sep 2022
Serpex Medical Announces Second FDA 510(k) Clearance of its Steerable Endobronchial Instrument Platform - The Compass Steerable Needle
Devices FDA
 HSMN NewsFeed - 6 Sep 2022
Boston Scientific Receives FDA Approval for Expanded Labeling of WATCHMAN FLX(TM) LAAC Device for Dual Anti-Platelet Therapy as Post-Procedural Medication Option
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 30 Aug 2022
Rafa Receives FDA Approval For Life-saving Midazolam Autoinjector
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 26 Aug 2022
Inhibikase Therapeutics Announces FDA Clearance of Investigational New Drug Application for IkT-001Pro for the Treatment of Chronic Myelogenous Leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 19 Aug 2022
Calyptus Pharmaceuticals Announces FDA Approval of Cetrorelix Acetate for Injection, 0.25 mg/vial
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 19 Aug 2022
Verismo Therapeutics Announces Submission of IND Application to the FDA for SynKIR-110TM, a KIR-CAR T-cell Immunotherapy Candidate
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 18 Aug 2022
U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Aug 2022
Akorn Announces FDA-approved Generic Cetrorelix Acetate for Injection 0.25 mg
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 15 Aug 2022
Alternative Pathway Blocker Anti-Bb Antibody (NM8074) Receives US FDA Clearance to Start Efficacy Trial in C3 Glomerulopathy (C3G) Patients
Biopharmaceuticals FDA
 HSMN NewsFeed - 9 Aug 2022
CereVasc Announces FDA Approval of Second IDE Study of the eShunt(R) System
Devices Neurosurgery Interventional FDA
 HSMN NewsFeed - 8 Aug 2022
MicroPort Navibot Receives 510(K) Clearance for its SkyWalker(TM) Robot-Assisted Platform for Orthopedic Applications
Devices Orthopaedic FDA
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