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Healthcare News Roundup: 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
 HSMN NewsFeed - 25 Nov 2020
Eiger BioPharmaceuticals Announces FDA Approval of Zokinvy(TM) (lonafarnib): The First Treatment for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Nov 2020
FDA Clears First of its Kind Algorithm Suite for Personal ECG
Devices Monitoring Cardiology FDA
 HSMN NewsFeed - 20 Nov 2020
FDA grants Emergency Use Authorisation for baricitinib in hospitalised COVID-19 patients nine months after initial hypothesis was published by BenevolentAI
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Nov 2020
THINK Surgical(R) Receives FDA Clearance of Second-Generation Active Robot
Devices Orthopaedic Surgery FDA
 HSMN NewsFeed - 19 Nov 2020
LimaCorporate Announces FDA Approval for an IDE Study on SMR Stemless Reverse Shoulder System
Devices Orthopaedic FDA
 HSMN NewsFeed - 17 Nov 2020
Allotrope Medical Announces FDA Clearance of StimSite(TM)
Devices Surgery FDA
 HSMN NewsFeed - 17 Nov 2020
Corvia Medical Completes Randomization In REDUCE LAP-HF II Pivotal Trial And Gains FDA Authorization To Provide Continued Access For The Corvia Atrial Shunt
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 17 Nov 2020
SafKan Health Announces FDA 510(k) Clearance for First-of-its-Kind OtoSet(TM) Ear Cleaning System
Devices FDA
 HSMN NewsFeed - 11 Nov 2020
Nanowear Receives FDA 510(k) Clearance for SimpleSENSE, a Cloth-Based Wearable Remote Diagnostic Monitoring Platform
Devices Monitoring FDA
 HSMN NewsFeed - 10 Nov 2020
icotec ag Receives FDA Clearance for the VADER(R) Pedicle - System with Bone Cement Augmentation
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 5 Nov 2020
Quansys Biosciences Receives FDA Emergency Use Authorization for its SARS-CoV-2 IgG Antibody Test that Provides Exceptional Clinical Performance
Diagnostics FDA
 HSMN NewsFeed - 3 Nov 2020
FDA Approves Updated Label for Endari(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Nov 2020
Salvia BioElectronics receives FDA Breakthrough Device Designation for innovative neurostimulation solution
Devices Neurology FDA
 HSMN NewsFeed - 2 Nov 2020
Boston Scientific Receives FDA Approval for the Ranger(TM) Drug-Coated Balloon
Devices Interventional FDA Product Launch
 HSMN NewsFeed - 29 Oct 2020
Roche receives FDA approval for the cobas EGFR Mutation Test v2 as the first companion diagnostic test for expanded EGFR TKI therapies in patients with non-small cell lung cancer
Diagnostics Oncology FDA
 HSMN NewsFeed - 29 Oct 2020
Medtronic Expands ENT Portfolio with FDA Clearance of NIM Vital(TM) Next Generation Intraoperative Nerve Monitoring System and Acquisiton of Ai Biomed Corp.
Devices Neurology FDA Mergers & Acquisitions
 HSMN NewsFeed - 28 Oct 2020
Virtual Incision Receives Investigational Device Exemption (IDE) to Initiate Study of First-of-its-Kind MIRA Platform
Devices Surgery FDA
 HSMN NewsFeed - 26 Oct 2020
Helix Receives Expanded Emergency Use Authorization for On-site Unsupervised Self-Collection and Asymptomatic Screening with the Helix(R) COVID-19 Test
Diagnostics FDA
 HSMN NewsFeed - 23 Oct 2020
GI Supply Gets FDA Clearance for its Submucosal Lifting Agent in a Second Size, a Pre-filled 10mL Syringe
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 21 Oct 2020
FDA Grants Fast Track Status to Aegle Therapeutics' AGLE-102 for the Treatment of Dystrophic Epidermolysis Bullosa
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 21 Oct 2020
Acuitive Technologies Granted FDA 510(k) Clearance for CITREGEN(TM) CITRELOCK(TM) Tendon Interference Screw System
Devices Orthopaedic FDA
 HSMN NewsFeed - 21 Oct 2020
Tyber Medical Receives FDA Clearance on Foot and Ankle Plating Systems
Devices Orthopaedic FDA
 HSMN NewsFeed - 20 Oct 2020
Ezra Receives FDA Clearance for Prostate Cancer Artificial Intelligence
Devices Radiology Urology FDA
 HSMN NewsFeed - 14 Oct 2020
Harmony Biosciences Receives FDA Approval For Expanded Use Of WAKIX(R) (pitolisant) For The Treatment Of Cataplexy In Adult Patients With Narcolepsy
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Oct 2020
Varian Receives Investigational Device Exemption (IDE) and Prepares for First Ever Clinical Trial of FLASH Therapy
Devices Oncology FDA
 HSMN NewsFeed - 12 Oct 2020
CartiHeal Receives FDA "Breakthrough Device Designation" for the novel Agili-C Implant
Devices Regenerative Medicine Orthopaedic FDA
 HSMN NewsFeed - 5 Oct 2020
BD Granted FDA 510(k) Clearance for BD FACSLyric(TM) Flow Cytometer with Newly Integrated BD FACSDuet(TM) Sample Preparation System
Diagnostics FDA
 HSMN NewsFeed - 5 Oct 2020
CARsgen Therapeutics Granted Orphan Drug Designation by the US FDA for CT041 CLDN18.2 CAR-T Cells for the Treatment of Gastric and Gastroesophageal Junction Cancers
Biopharmaceuticals Oncology FDA
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