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Healthcare News Roundup: FDA

 HSMN NewsFeed - 24 Jul 2019
FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants; Requests Allergan Voluntarily Recall Certain Breast Implants and Tissue Expanders from Market
Devices FDA Product Recall
 HSMN NewsFeed - 24 Jul 2019
Exogenesis Corporation Announces the Filing of a 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for Exogenesis Hernia Mesh
Devices Surgery FDA
 HSMN NewsFeed - 23 Jul 2019
Lipocine Receives FDA Clearance for Clinical Testing its NASH Candidate, LPCN 1144, in Expanded Target Population
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Jul 2019
Vanda Pharmaceuticals FDA Update for HETLIOZ(R) in the Treatment of Jet Lag Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Jul 2019
FDA Clears Erchonia's FX 635 for Relief of Chronic Musculoskeletal Pain
Devices FDA
 HSMN NewsFeed - 17 Jul 2019
U.S. FDA Accepts Allergan's New Drug Application for Bimatoprost Sustained-Release in Patients with Open-Angle Glaucoma or Ocular Hypertension
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 17 Jul 2019
Q'Apel Medical Announces FDA Clearance for Walrus Balloon Guide Catheter
Devices Interventional FDA
 HSMN NewsFeed - 15 Jul 2019
Alkermes Expands Planned New Drug Application for ALKS 3831 to Include Treatment of Bipolar I Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 15 Jul 2019
AirXpanders(R) Receives FDA 510(k) Clearance for a Smooth Shell Version of the AeroForm(R) Tissue Expander System
Devices Oncology Surgery FDA
 HSMN NewsFeed - 12 Jul 2019
Neovasc to Explore HDE Approval Pathway and Alternate Trial Designs for the Reducer Following Guidance from the FDA
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 11 Jul 2019
Abbott Announces FDA Approval of the Alinity(TM) s System, the Latest Technology for Screening and Protecting the U.S. Blood and Plasma Supply
Diagnostics FDA
 HSMN NewsFeed - 11 Jul 2019
RaySearch Receives FDA Clearance for RayStation 8B Including Machine Learning Functionalities
Devices Radiology Oncology FDA
 HSMN NewsFeed - 8 Jul 2019
BIOTRONIK Receives FDA Clearance on Next-Gen Injectable Cardiac Monitor: BIOMONITOR III
Devices Cardiology Monitoring FDA
 HSMN NewsFeed - 27 Jun 2019
DURECT Announces Submission to FDA of a Full Response to the POSIMIR(R) Complete Response Letter
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 27 Jun 2019
Dignitana receives FDA clearance for DigniCap Delta scalp cooling system
Devices FDA
 HSMN NewsFeed - 26 Jun 2019
U.S. FDA Grants Fast Track Designation to Empagliflozin for the Treatment of Chronic Heart Failure
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 25 Jun 2019
Dominion Aesthetic Technologies Announces FDA Clearance of eon(TM) FR, Non-Contact Body Sculpting
Devices FDA
 HSMN NewsFeed - 24 Jun 2019
Micro Medical Solutions Receives FDA IDE Approval for Pivotal Clinical Trial of MicroStent
Devices Interventional FDA
 HSMN NewsFeed - 24 Jun 2019
Allergan Receives FDA Clearance For CoolTone(TM) Device
Devices Dermatology FDA
 HSMN NewsFeed - 24 Jun 2019
Correvio Resubmits Brinavess (Vernakalant) New Drug Application to U.S. FDA for the Treatment of Patients with Recent Onset Atrial Fibrillation
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 21 Jun 2019
Daiichi Sankyo Provides Update on FDA Review of Quizartinib for the Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 21 Jun 2019
FDA Approves BOTOX(R) (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity
Biopharmaceuticals 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
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