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The Healthcare Sales & Marketing Network celebrates 27 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 - 19 Jan 2026
FDA Grants Regenerative Medicine Advanced Therapy (RMAT) Designation to iRegene's NouvNeu001, Making It the World's First iPSC Therapy with Both FTD and RMAT Recognitions
Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 15 Jan 2026
BD Receives FDA 510(k) Clearance for EnCor EnCompass(TM) Breast Biopsy and Tissue Removal System
Devices FDA
 HSMN NewsFeed - 12 Jan 2026
Neurolief receives FDA PMA Approval for First At-Home Brain Neuromodulation Therapy for Adults Whose Depression Was Not Adequately Improved by Antidepressants
Devices Neurology FDA
 HSMN NewsFeed - 5 Jan 2026
ScinoPharm Secures U.S. FDA Approval for Glatiramer Acetate Injection for the Treatment of Multiple Sclerosis
Biopharmaceuticals Generics Neurology FDA
 HSMN NewsFeed - 30 Dec 2025
HAI Solutions Receives FDA De Novo Grant for QIKCAP System: Pioneering UVC Technology for Microbial Reduction on Needleless IV Connectors
Devices FDA
 HSMN NewsFeed - 29 Dec 2025
FDA Accepts for Review INOVIO's BLA for INO-3107 for the Treatment of Adults with Recurrent Respiratory Papillomatosis (RRP)
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Dec 2025
U.S. FDA Approves JASCAYD(R) (nerandomilast) Tablets for the Treatment of Progressive Pulmonary Fibrosis in Adults
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 Dec 2025
Vesalio Receives FDA 510(k) Clearance of enVast, the First Stent-Based Coronary Thrombectomy Technology
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 8 Dec 2025
EyeYon Medical Ltd. Receives FDA IDE Approval to Initiate U.S. Clinical Study of EndoArt(R), the First Artificial Endothelial Layer for Corneal Edema
Devices Ophthalmology FDA
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