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Healthcare News Roundup: FDA

 HSMN NewsFeed - 2 Aug 2021
Abbott's FreeStyle(R) Libre 2 iOS App Cleared in U.S., Providing a Seamless Digital Experience to Simplify Diabetes Management
Devices Monitoring Endocrinology FDA
 HSMN NewsFeed - 2 Aug 2021
RealView Imaging Ltd., World Leader in Medical Holography, Receives FDA Clearance for its Groundbreaking HOLOSCOPE(TM)-i Holographic System
Devices Radiology FDA
 HSMN NewsFeed - 2 Aug 2021
Alkermes Receives FDA Fast Track Designation for Nemvaleukin Alfa for the Treatment of Mucosal Melanoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 Jul 2021
NuVasive Receives Latest FDA 510(k) Clearance for Pulse Platform and Announces Commercial Launch
Devices Neurosurgery Orthopaedic FDA Product Launch
 HSMN NewsFeed - 28 Jul 2021
Medtronic Announces FDA Clearance and Results of Artificial Intelligence Algorithms for Cardiac Monitoring
Devices Cardiology FDA
 HSMN NewsFeed - 21 Jul 2021
FDA Grants Breakthrough Designation to Synapse Biomedical's TransAeris(R) System
Devices FDA
 HSMN NewsFeed - 20 Jul 2021
First Light Diagnostics Receives FDA Clearance for its Rapid Clostridiodes difficile Test on the MultiPath(R) Analyzer
Diagnostics FDA
 HSMN NewsFeed - 20 Jul 2021
Alma, a Sisram Medical Company, Announces FDA Clearance and the U.S. Launch of Alma Hybrid(TM)
Devices Dermatology FDA Product Launch
 HSMN NewsFeed - 19 Jul 2021
BlueRock Therapeutics Receives FDA Fast Track Designation for DA01 in the Treatment of Advanced Parkinson's Disease
Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 19 Jul 2021
Nevro Announces FDA Approval of its 10 kHz High Frequency Spinal Cord Stimulation Therapy for Treatment of Chronic Pain Associated with Painful Diabetic Neuropathy (PDN)
Devices Neurology FDA Product Launch
 HSMN NewsFeed - 15 Jul 2021
iSTAR Medical receives U.S. FDA approval to start pivotal trial for MINIject in glaucoma patients
Devices Ophthalmology FDA
 HSMN NewsFeed - 13 Jul 2021
Stryker announces the FDA clearance of the first biodegradable subacromial balloon spacer, filling a gap in the shoulder continuum of care
Devices Orthopaedic FDA
 HSMN NewsFeed - 12 Jul 2021
Janssen Announces U.S. FDA Approval of DARZALEX FASPRO(R) (daratumumab and hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 12 Jul 2021
FDA Approves Expanded Sterilization and Disinfectant Methods for the LUMINELLE(R) DTx System
Devices FDA
 HSMN NewsFeed - 7 Jul 2021
Hyalex Orthopaedics receives FDA Breakthrough Device Designation for novel HYALEX(R) Cartilage System
Devices Orthopaedic FDA
 HSMN NewsFeed - 30 Jun 2021
Abbott's XIENCE Stent Receives FDA Approval for Shortest Blood Thinner Course for High Bleeding Risk Patients
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 29 Jun 2021
Inova Diagnostics Announces FDA 510(k) Clearance for Aptiva(R), a Digital Multi-Analyte System
Diagnostics FDA
 HSMN NewsFeed - 29 Jun 2021
Interventional Systems Receives FDA Clearance for its All-around Miniature Medical Robot
Devices Interventional FDA
 HSMN NewsFeed - 29 Jun 2021
FDA Grants Fast Track Designation to CNS Pharmaceuticals for Berubicin for the Treatment of Recurrent Glioblastoma Multiforme
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 25 Jun 2021
Jazz Pharmaceuticals Announces Orphan Drug Exclusivity for Xywav(TM) (calcium, magnesium, potassium, and sodium oxybates) Oral Solution
Biopharmaceuticals FDA
 HSMN NewsFeed - 24 Jun 2021
Lilly's donanemab receives U.S. FDA's Breakthrough Therapy designation for treatment of Alzheimer's disease
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 23 Jun 2021
BD Announces Expanded 510(k) Clearance for At-Home System for Ascites
Devices FDA
 HSMN NewsFeed - 17 Jun 2021
Irrimax Receives FDA Clearance for Irrisept(R) as an Antimicrobial Wound Lavage for US Market
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Jun 2021
Elekta radiotherapy system designed for changing cancer landscape now available for U.S. patients
Devices Oncology FDA
 HSMN NewsFeed - 16 Jun 2021
Spark(TM) Aligners Receive FDA Clearance For Orthodontic Treatment Of Kids, Giving Parents A New Option With Significant Treatment Advantages Over The Leading Competitor
Devices Dental FDA
 HSMN NewsFeed - 14 Jun 2021
FDA Clears LPCN 1154 IND Application for a Phase 2 Postpartum Depression Study
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 Jun 2021
Nuvo Group Receives 510(k) FDA Clearance for Remote Monitoring of Uterine Activity
Devices Monitoring FDA
 HSMN NewsFeed - 10 Jun 2021
Cardinal Health(TM) Nuclear & Precision Health Solutions Receives U.S. Food and Drug Administration Approval for New LYMPHOSEEK(R) Pediatric Indication
Biopharmaceuticals Radiology Oncology FDA
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