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Healthcare News Roundup: FDA

 HSMN NewsFeed - 19 Jan 2021
Eitan Medical Receives FDA Clearance for Upgraded Sapphire(TM) Infusion Pump System
Devices FDA
 HSMN NewsFeed - 19 Jan 2021
Occlutech's Atrial Flow Regulator (AFR) Receives U.S. FDA Breakthrough Device Designation for Heart Failure (HF)
Devices Cardiology FDA
 HSMN NewsFeed - 14 Jan 2021
SML Genetree Receives FDA Emergency Use Authorization for Ezplex SARS-CoV-2 G Real-Time PCR Kit with Specimen Pooling Capability
Diagnostics FDA
 HSMN NewsFeed - 12 Jan 2021
Lower-Profile Web Intrasaccular Aneurysm Treatment Device Receives FDA Approval
Devices Neurosurgery FDA
 HSMN NewsFeed - 11 Jan 2021
MedSkin Solutions Dr. Suwelack AG Receives FDA 510(k) Clearance for MatriDerm(R) - Its Three-Dimensional Acellular Collagen Elastin Dermal Matrix Portfolio
Devices Dermatology FDA
 HSMN NewsFeed - 6 Jan 2021
Ultromics receives FDA Clearance for a first-of-kind solution in Echocardiography to help clinicians diagnose disease
Devices Cardiology Radiology FDA
 HSMN NewsFeed - 5 Jan 2021
Sebela Pharmaceuticals Announces U.S. Launch of SUTAB(R) Tablets, An Alternative to Liquid Colonoscopy Preparation
Biopharmaceuticals Gastroenterology FDA Product Launch
 HSMN NewsFeed - 24 Dec 2020
Interscope Announces FDA De Novo Marketing Authorization of the EndoRotor(R) System for Direct Endoscopic Necrosectomy (DEN)
Devices Surgery FDA
 HSMN NewsFeed - 23 Dec 2020
FDA Approves Bracco Diagnostics Inc.'s ProHance(R) (Gadoteridol) Injection, 279.3 mg/mL, for Pediatric Patients Younger than Two Years
Biopharmaceuticals Radiology FDA
 HSMN NewsFeed - 22 Dec 2020
Nephron Announces FDA Approval of Ketorolac, Signaling New Phase of Growth
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 21 Dec 2020
Anixa Biosciences and Cleveland Clinic Announce FDA Clearance to Initiate Clinical Trial of Breast Cancer Vaccine
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 21 Dec 2020
Moebius Medical Announces FDA Clearance of IND Application for Phase IIb Clinical Trial of MM-II, a Novel Treatment for Knee Osteoarthritis Pain
Biopharmaceuticals Orthopaedic FDA
 HSMN NewsFeed - 18 Dec 2020
Arthrex Launches First FDA-Cleared ACL Primary Repair Kit
Devices Orthopaedic FDA Product Launch
 HSMN NewsFeed - 18 Dec 2020
Occlutech's Atrial Flow Regulator (AFR) Receives U.S. FDA Breakthrough Device Designation
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 18 Dec 2020
Polaryx Therapeutics Receives Both Rare Pediatric Disease and Orphan Drug Designations for the Treatment of Niemann Pick Disease Types A and B With PLX-300
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 17 Dec 2020
FDA Approves GSK's BENLYSTA as the First Medicine for Adult Patients with Active Lupus Nephritis in the US
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Dec 2020
FDA Clears Fever-Detecting Vital Data Sensor in New Cardiac MonitorFDA Clears Fever-Detecting Vital Data Sensor in New Cardiac Monitor
Devices Monitoring Cardiology FDA
 HSMN NewsFeed - 16 Dec 2020
Medtronic Strengthens Leadership in Navigated, Robotic Spine Surgery with FDA Clearance of Midas Rex(TM) Drills and Navigated Disc Prep and Interbodies for U.S. with Mazor(TM) Robotic Guidance System
Devices FDA
 HSMN NewsFeed - 15 Dec 2020
Almirall announces FDA approval of Klisyri(R) (tirbanibulin), a new innovative topical treatment for actinic keratosis
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 10 Dec 2020
FDA Approves Novadoz Pharmaceuticals Toremifene and Aminocaproic Acid, Bolstering their Continued Growth in Generics
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 10 Dec 2020
ReCor Medical Announces Positive Results in RADIANCE-HTN TRIO Study and Breakthrough Device Designation for Paradise(TM) Ultrasound Renal Denervation System
Devices Cardiology FDA
 HSMN NewsFeed - 9 Dec 2020
Mesa Biotech Receives 510(k) Clearance and CLIA Waiver for Its Accula(TM) Strep A Molecular Point of Care Test
Diagnostics FDA
 HSMN NewsFeed - 8 Dec 2020
Amgen's Sotorasib Granted Breakthrough Therapy Designation for Advanced or Metastatic Non-Small Cell Lung Cancer Patients with KRAS G12C Mutation
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 1 Dec 2020
Novartis announces FDA approval of Xolair(R) (omalizumab) for adults with nasal polyps
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Nov 2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Extension of PDUFA Date for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease
Biopharmaceuticals FDA
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