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The Healthcare Sales & Marketing Network celebrates 28 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 - 11 Feb 2026
Labcorp Launches First FDA-Cleared Blood Test for Alzheimer's Disease Assessment in Primary Care
Diagnostics Neurology Product Launch
 HSMN NewsFeed - 10 Feb 2026
Vesalio Expands International Neurovascular Portfolio with CE Mark of NeVa VS and NeVa 3.0 mm and Receives Additional FDA 510(k) Clearance for its Aspiration Catheters
Devices Neurology Interventional Regulatory
 HSMN NewsFeed - 29 Jan 2026
FDA Qualifies MolecuLightDX Wound Measurement as a Medical Device Development Tool (MDDT) for Evaluating New Products in Wound Care
Devices Wound Care FDA
 HSMN NewsFeed - 28 Jan 2026
REGENXBIO Announces Regulatory Update on Ultra Rare MPS Programs
Regenerative Medicine FDA
 HSMN NewsFeed - 26 Jan 2026
StemCyte Announces FDA Clearance of Expanded Access Program for RegeneCyte(R) (HPC, Cord Blood) to Address Unmet Need in Long COVID
Regenerative Medicine 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
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