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Healthcare News Roundup: FDA

 HSMN NewsFeed - 19 Jun 2019
CARsgen Therapeutics Receives IND Clearance for BCMA-CAR-T Cells from the U.S. FDA
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 18 Jun 2019
FDA Grants Fast Track Designation for Torque's First Deep-Primed T Cell Cancer Immunotherapy Program, TRQ-1501
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 18 Jun 2019
Breakthrough Device Designation received from the FDA
Devices FDA
 HSMN NewsFeed - 17 Jun 2019
FDA approves new cochlear implant with easier access to MRI and expanded connectivity ready for Google's direct streaming to Android smartphones
Devices FDA
 HSMN NewsFeed - 14 Jun 2019
Medline Announces First Infection Control Product EPA-registered to Kill Emerging Pathogen
Devices FDA Product Launch Distribution
 HSMN NewsFeed - 11 Jun 2019
AI for C-Spine Fractures: Aidoc Sets the Pace With 3rd FDA Clearance in 9 Months
Devices Radiology Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 6 Jun 2019
Palatin Technologies Granted FDA Orphan Drug Designation -- PL-8177 for the Treatment of Non-Infectious Uveitis
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 5 Jun 2019
FDA Premarket Approval Granted for DT MedTech's Hintermann Series H3(TM) Total Ankle Replacement System
Devices Orthopaedic FDA
 HSMN NewsFeed - 4 Jun 2019
GORE(R) CARDIOFORM ASD Occluder Receives FDA Approval for the Treatment of Atrial Septal Defects
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 30 May 2019
U.S. FDA Approves Supplemental New Drug Application Adding Overall Survival Data for XOSPATA(R) (gilteritinib)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 28 May 2019
FDA Grants Theranica De Novo to Market First Smartphone-controlled Acute Migraine-relief Wearable Device
Devices Neurology FDA
 HSMN NewsFeed - 28 May 2019
True Diagnostics, Inc. Receives FDA 510(k) Clearance to Market VeriClear(TM) Digital Test Device for Early Result Pregnancy
Diagnostics 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
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