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Healthcare News Roundup: FDA

 HSMN NewsFeed - 24 Jan 2020
Abbott Receives Expanded Indication From the U.S. FDA for Directional Deep Brain Stimulation System to Treat Parkinson's Disease
Devices Neurology FDA
 HSMN NewsFeed - 22 Jan 2020
Celularity Announces FDA Clearance of Landmark IND for CYNK-001, an Allogeneic, Off-the-Shelf Cryopreserved NK Cell Therapy
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 21 Jan 2020
VivaLNK Announces World's First FDA Cleared Wearable ECG Sensor Platform
Devices Monitoring Cardiology FDA
 HSMN NewsFeed - 17 Jan 2020
DURECT Corporation Announces Outcome of FDA Advisory Committee Meeting for POSIMIR(R)
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 16 Jan 2020
ANI Pharmaceuticals Announces FDA Approval of Potassium Citrate Extended-Release Tablets USP
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 13 Jan 2020
Dova Granted Orphan Drug Designation for Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 13 Jan 2020
Lannett Announces FDA Approval Of NDA For Branded Anesthetic Product, Cocaine Hydrochloride Nasal Solution 4%
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 9 Jan 2020
Presage Receives FDA Clearance of First IND Application for Trial to Evaluate Investigational Oncology Agents with CIVO(TM) Technology
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 9 Jan 2020
MicroVention Announces FDA Premarket Approval of a New Flow Diverter for the Treatment of Brain Aneurysms
Devices Interventional Neurology FDA
 HSMN NewsFeed - 8 Jan 2020
Aruvant Receives FDA Rare Pediatric Disease Designation for ARU-1801 for the Treatment of Sickle Cell Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 7 Jan 2020
IceCure Receives FDA Clearance for Expanded Indications of Cryoablation Technology and Regulatory Approval of New MultiSense System; Plans to Increase U.S. Presence and Operations
Devices Oncology FDA
 HSMN NewsFeed - 26 Dec 2019
OBI Pharma Granted FDA Orphan Drug Designation for the Treatment of Pancreatic Cancer for Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 24 Dec 2019
Correvio Receives Complete Response Letter From U.S. FDA for Brinavess and Provides Update on Recent Events
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 23 Dec 2019
Lannett Receives FDA Approvals For Two Dosage Strengths Of Butalbital, Acetaminophen And Caffeine Capsules
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 19 Dec 2019
Interscope announces new FDA Clearance of the EndoRotor(R), for use in Airway procedures including in Interventional Pulmonology
Devices Interventional Pulmonology FDA
 HSMN NewsFeed - 16 Dec 2019
FDA Approves Diffusion-Weighted Images for Elekta Unity, Expanding Options for Assessment During Therapy
Devices Oncology FDA
 HSMN NewsFeed - 11 Dec 2019
FDA clears Cochlear's innovative new Osia(R) 2 hearing implant system
Devices FDA
 HSMN NewsFeed - 11 Dec 2019
Correvio Announces Intention to Explore Strategic Alternatives to Maximize Stakeholder Value
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 10 Dec 2019
Neuspera Medical Receives Investigational Device Exemption for Its Ultra-Miniaturized Implantable Device
Devices Urology Neurology FDA
 HSMN NewsFeed - 10 Dec 2019
Shoulder Innovations Announces FDA 510(k) Clearance For InSet Plus(TM) Augmented Glenoids For Total Shoulder System
Devices Orthopaedic FDA
 HSMN NewsFeed - 9 Dec 2019
BIOLASE Announces Clearance of the Epic Hygiene Laser for Dental Hygienists
Devices Dental FDA Product Launch
 HSMN NewsFeed - 9 Dec 2019
HIZENTRA(R) (Immune Globulin Subcutaneous [Human] 20% Liquid) Receives Orphan-Drug Exclusivity for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 6 Dec 2019
3DBio Therapeutics Receives FDA Rare Pediatric Disease Designation for AuriNovo(TM) for Ear Reconstruction in Microtia Patients
Devices Regenerative Medicine 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
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