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Healthcare News Roundup: FDA

 HSMN NewsFeed - 22 May 2019
FDA Approves SORILUX(R) for Adolescent Plaque Psoriasis
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 21 May 2019
Perrigo Announces FDA Final Approval For AB Rated Generic Version Of Voltaren(R) Gel 1%
Biopharmaceuticals Generics FDA Product Launch
 HSMN NewsFeed - 20 May 2019
UCB announces NAYZILAM(R) (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S.
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 17 May 2019
U.S. FDA Approves GATTEX(R) (teduglutide) for Children 1 Year of Age and Older With Short Bowel Syndrome (SBS)
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 17 May 2019
Soliton Provides FDA Update and Addresses Recent Anonymous Article
Devices Dermatology FDA
 HSMN NewsFeed - 16 May 2019
GenePOC Obtains FDA Clearance for its GenePOC(TM) Carba Test in the US
Diagnostics FDA
 HSMN NewsFeed - 13 May 2019
Proteostasis Therapeutics Appoints Dr. Badrul Chowdhury, Former FDA Director of Pulmonology, Allergy, and Rheumatology, to Board of Directors
Biopharmaceuticals Personnel
 HSMN NewsFeed - 13 May 2019
FDA Grants First Ever Clearance For Six-Lead Personal ECG Device
Devices Monitoring Cardiology FDA
 HSMN NewsFeed - 10 May 2019
NeuroVive's IND for Clinical Development of NeuroSTAT Approved by FDA
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 7 May 2019
Rapid Medical Announces FDA Approval of Novel Temporary Aneurysm Embolization Assist Device
Devices Interventional FDA
 HSMN NewsFeed - 6 May 2019
Boston Scientific Receives U.S. FDA Approval for The VICI VENOUS STENT(TM) System
Devices Interventional FDA
 HSMN NewsFeed - 3 May 2019
Caris Life Sciences Receives FDA Breakthrough Device Designation for MI Transcriptome(TM) Companion Diagnostic Test
Diagnostics Oncology FDA
 HSMN NewsFeed - 2 May 2019
FDA Grants Breakthrough Device Designation to KidneyIntelX(TM)
Diagnostics FDA
 HSMN NewsFeed - 2 May 2019
Concept Medical Inc. Granted 'Breakthrough Device Designation' From FDA for Its MagicTouch Sirolimus Coated Balloon
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 30 Apr 2019
510(k) Market Clearance for FluChip-8G Influenza A+B Assay
Diagnostics FDA
 HSMN NewsFeed - 29 Apr 2019
CoapTech Receives FDA 510(k) Clearance for Its PUMA-G System
Devices Gastroenterology FDA
 HSMN NewsFeed - 29 Apr 2019
U.S. FDA Accepts New Drug Application and Grants Priority Review for Darolutamide
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 29 Apr 2019
United Therapeutics Announces FDA Approval Of XPS(TM) And Steen Solution(TM) Used To Perform Centralized Ex-Vivo Lung Perfusion Services
Devices FDA
 HSMN NewsFeed - 25 Apr 2019
CSL Behring Delivers on its Continued Commitment to Alpha 1 Patients with FDA Approval of Convenient Single-Vial Dosing for ZEMAIRA(R) [Alpha1-Proteinase Inhibitor (Human)]
Biopharmaceuticals FDA Product Launch
 HSMN NewsFeed - 23 Apr 2019
FDA Grants First-Ever Clearances to Detect Bradycardia and Tachycardia on a Personal ECG Device
Devices Monitoring Cardiology FDA
 HSMN NewsFeed - 18 Apr 2019
TELA Bio(R) Announces 510(k) Clearance for Restella(TM) Reconstructive BioScaffolds for Reconstructive Surgery
Devices Surgery FDA
 HSMN NewsFeed - 18 Apr 2019
Beckman Coulter's Early Sepsis Indicator Receives 510(k) Clearance from the U.S. Food and Drug Administration
Devices Diagnostics FDA
 HSMN NewsFeed - 17 Apr 2019
FDA Grants Breakthrough Device Designation For Advanced Prenatal Therapeutics' Targeted Apheresis Column For Preeclampsia
Devices FDA
 HSMN NewsFeed - 16 Apr 2019
Viracta Receives Orphan Drug Designation from the US FDA for its Lead Epigenetic Drug Candidate Nanatinostat for EBV-Associated Cancers
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Apr 2019
Aprea Therapeutics Receives FDA Fast Track Designation and Orphan Drug Designation for APR-246 for the Treatment of Myelodysplastic Syndromes (MDS)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 10 Apr 2019
Getinge Receives 510(k) Clearance From US FDA for Software Upgrade in Servo-u(R) and Servo-n(R) Ventilator Platform
Devices FDA
 HSMN NewsFeed - 9 Apr 2019
Innoblative's SIRA(TM) RFA Electrosurgical Device Receives FDA Clearance
Devices Surgery FDA
 HSMN NewsFeed - 9 Apr 2019
FDA Clears VITROS(R) XT Chemistry Product Slides from Ortho Clinical Diagnostics
Diagnostics FDA
 HSMN NewsFeed - 8 Apr 2019
BD Unveils Platelet Quality Control Media to Help Reduce the Incidence of Sepsis in Patients Requiring Platelet Transfusion
Diagnostics FDA Product Launch
 HSMN NewsFeed - 4 Apr 2019
Magstim TMS Receives FDA Clearance for 3- minute Theta Burst Treatment
Devices Neurology FDA
 HSMN NewsFeed - 4 Apr 2019
Daiichi Sankyo Provides Update on Ongoing FDA Review for Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 3 Apr 2019
CSA Medical, Inc. Receives FDA Breakthrough Device Designation and IDE Approval for its RejuvenAir(R) System for COPD Patients with Chronic Bronchitis
Devices FDA
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