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The Healthcare Sales & Marketing Network celebrates 23 years serving the medical sales & marketing community.Connecting Medical Independent Sales Reps and Distributors with Manufacturers and New Product LinesConnecting Medical Independent Sales Reps and Distributors with Manufacturers and New Product Lines

Healthcare News Roundup: FDA

 HSMN NewsFeed - 26 Aug 2021
FDA Clears Thermo Scientific EliA SmD(P)-S Test For Use In U.S.
Diagnostics FDA
 HSMN NewsFeed - 24 Aug 2021
InDex Pharmaceuticals receives FDA clearance to start the phase III study CONCLUDE with cobitolimod
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 23 Aug 2021
Shoulder Innovations Announces FDA 510(k) Clearance For InSet(TM) Reverse Shoulder Platform Technology
Devices Orthopaedic FDA
 HSMN NewsFeed - 18 Aug 2021
Zimmer Biomet Receives FDA Clearance for ROSA(R) Hip System for Robotically-Assisted Direct Anterior Total Hip Arthroplasty
Devices Orthopaedic FDA
 HSMN NewsFeed - 16 Aug 2021
Abbott's Amplatzer(TM) Amulet(TM) Device Approved by FDA to Treat People With Atrial Fibrillation at Risk of Stroke
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 16 Aug 2021
Occlutech granted important conditional FDA approval for PFO Study (OCCLUFLEX) in the U.S.
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 12 Aug 2021
Medcura raises $7.4 Million to Expand FDA-Approved Line of Hemostatic and Wound Treatment Products
Devices Surgery Venture Capital
 HSMN NewsFeed - 12 Aug 2021
Second U.S. FDA Breakthrough Device Designation Granted to CytoSorbents' DrugSorb-ATR(TM) Antithrombotic Removal System Adding the Removal of Market-Leading Direct Oral Anticoagulants During Urgent Cardiothoracic Surgery
Devices FDA
 HSMN NewsFeed - 12 Aug 2021
Syntr Health Technologies Announces an Oversubscribed $2.2 Million Seed Round to Accelerate Market Penetration of FDA-Cleared SyntrFuge System
Devices Surgery Venture Capital Personnel
 HSMN NewsFeed - 12 Aug 2021
Syntr Health Technologies Announces FDA Clearance of the SyntrFuge System for use in Specialty Surgeries Requiring Transfer and Implantation of Patient's Own Fat Tissue
Devices Surgery FDA
 HSMN NewsFeed - 11 Aug 2021
FDA Grants Lantern Pharma Orphan Drug Designation for Drug Candidate LP-184 in the Treatment of Pancreatic Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 9 Aug 2021
SpinTech Receives FDA 510(k) Clearance for STAGE Technology
Devices Radiology Neurology FDA
 HSMN NewsFeed - 6 Aug 2021
FDA Approves New Treatment for Pompe Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 Aug 2021
Breckenridge Announces Final Approval of its ANDA for Apixaban Tablets (generic for Eliquis(R))
Biopharmaceuticals Generics 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
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