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Healthcare News Roundup: FDA

 HSMN NewsFeed - 5 Dec 2019
MolecuLight Receives FDA 510(k) Clearance for its i:X(R) Handheld Fluorescence Imaging Device for Wound Management
Devices Diagnostics Wound Care FDA
 HSMN NewsFeed - 4 Dec 2019
Vicarious Surgical Announces Breakthrough Designation by the FDA, Appoints Scott Huennekens to Board of Directors
Devices Surgery FDA Personnel
 HSMN NewsFeed - 2 Dec 2019
Cumberland Pharmaceuticals Receives FDA Approval for RediTrex(TM) Product Line
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Nov 2019
Evofem Biosciences Resubmits New Drug Application to U.S. FDA for Amphora(R) for the Prevention of Pregnancy
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Nov 2019
INHIBITOR Therapeutics Submits Investigational New Drug Application for Treatment of Patients with Late-Stage Prostate Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 18 Nov 2019
Levo Therapeutics Receives Fast Track Designation From FDA for Intranasal Carbetocin for the Treatment of Prader-Willi Syndrome
Biopharmaceuticals Neurology Drug Delivery FDA
 HSMN NewsFeed - 18 Nov 2019
Protalix BioTherapeutics and Chiesi Farmaceutici Announce Successful pre-BLA Meeting with FDA for Accelerated Approval of pegunigalsidase alfa for the Treatment of Fabry Disease in the United States
Biopharmaceuticals FDA
 HSMN NewsFeed - 14 Nov 2019
Ultromics Receives FDA Clearance for its AI-powered Decision Support System, EchoGo Core
Devices Cardiology FDA
 HSMN NewsFeed - 11 Nov 2019
Allergan Receives FDA Qualified Infectious Disease Product (QIDP) Designation And Fast Track Designation For ATM-AVI (Aztreonam And Avibactam) For Antibiotic-Resistant Gram-Negative Infections
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 Nov 2019
AI Medical Service Inc. announces FDA Breakthrough Device Designation for endoscopic AI system
Devices Gastroenterology FDA
 HSMN NewsFeed - 11 Nov 2019
Lipocine Receives Complete Response Letter for TLANDO(TM) from U.S. FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Nov 2019
Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA Seeking Approval of IMBRUVICA(R) (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 7 Nov 2019
EIP Pharma Announces U.S. FDA Grants Fast-Track Designation to Neflamapimod as a Treatment for Dementia with Lewy Bodies (DLB)
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 5 Nov 2019
Nevro Announces U.S. Launch of Senza(R) Omnia(TM) Spinal Cord Stimulation System to Treat Chronic Pain
Devices Neurology FDA Product Launch
 HSMN NewsFeed - 31 Oct 2019
Stryker receives FDA clearance for SAHARA(R) Lateral 3D Expandable Interbody System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 31 Oct 2019
Cytotron(R) Granted 'Breakthrough Device Designation' by U.S. FDA for Treatment of Breast, Liver, and Pancreatic Cancers
Devices Oncology FDA
 HSMN NewsFeed - 30 Oct 2019
Biogen and Alkermes Announce FDA Approval of VUMERITY(TM) (diroximel fumarate) for Multiple Sclerosis
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 28 Oct 2019
SFA Therapeutics, Inc. Receives an FDA Orphan Drug Designation (ODD) for SFA001 in the Treatment of Hepatocellular Carcinoma (HCC)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 24 Oct 2019
Fresenius Medical Care Receives FDA Breakthrough Device Designation for New Dialysis System to Prevent Blood Clotting Without the Use of Blood Thinners
Devices FDA
 HSMN NewsFeed - 24 Oct 2019
FDA Approves BOTOX(R) (onabotulinumtoxinA) for Pediatric Patients with Lower Limb Spasticity, Excluding Spasticity Caused by Cerebral Palsy
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Oct 2019
Heron Announces FDA Approval of Supplemental New Drug Application to Expand CINVANTI(R) Label for Single-Dose Regimen for Patients Receiving Moderately Emetogenic Chemotherapy (MEC)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 18 Oct 2019
Nplate(R) (romiplostim) Now Approved For Earlier Use In Adults With Immune Thrombocytopenia
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Oct 2019
FDA Clears ORTHO(TM) Sera ID-MTS for Use on the ORTHO VISION(R) Analyzer
Diagnostics FDA
 HSMN NewsFeed - 17 Oct 2019
CarboFix Extends Its CarboClear(R) Carbon Fiber Spinal Product Line With Its FDA Cleared Vertebral Body Replacement (VBR) System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 16 Oct 2019
Fidmi Medical Receives FDA Regulatory Clearance for Low-profile Enteral Feeding Device
Devices FDA
 HSMN NewsFeed - 15 Oct 2019
BIOLASE Announces First-Ever U.S. & Canada Regulatory Clearance of Laser Crown and Veneer Removal
Devices Dental FDA Regulatory
 HSMN NewsFeed - 14 Oct 2019
OssDsign Receives US FDA Clearance for Cranial PSI Accessories - Strengthening Business Position in the US
Devices Neurosurgery FDA
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