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The Healthcare Sales & Marketing Network celebrates 28 years serving the medical sales & marketing community.Connecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product LinesConnecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product Lines

Healthcare News Roundup: FDA

 HSMN NewsFeed - 24 Sep 2025
TSC Life Receives FDA 510(K) Clearance for Fluido(R) AirGuard System, a Moderate to High Flow Blood and IV Fluid Warming Solution for the Prevention of Hypothermia
Devices FDA
 HSMN NewsFeed - 19 Sep 2025
Kelyniam Global, Inc. Receives FDA Clearance for Innovative Fusion(TM) BCP-PEEK Implant
Devices Neurosurgery FDA
 HSMN NewsFeed - 17 Sep 2025
Amber Implants Secures FDA 510(k) Clearance for VCFix(R) Spinal System: A Next-Generation Solution for Vertebral Compression Fractures
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 9 Sep 2025
ARTBIO Announces FDA Clearance of IND Application for Lead Alpha Radioligand Therapy AB001
Devices Oncology FDA
 HSMN NewsFeed - 8 Sep 2025
FDA Accepts Letter of Intent to Qualify LSM by VCTE (FibroScan(R)) as First Non-Invasive Surrogate Endpoint in MASH Clinical Trials
Diagnostics FDA
 HSMN NewsFeed - 4 Sep 2025
Sentec Receives FDA Clearance for LuMon(TM) Electrical Impedance Tomography (EIT) System -- First EIT System Indicated for Premature Infants and for Spontaneously Breathing Patients in the United States
Devices Monitoring FDA
 HSMN NewsFeed - 4 Sep 2025
4DMedical's CT:VQ(TM) Receives FDA 510(k) Clearance; First-and-Only CT-Based VQ Technology
Devices Radiology FDA
 HSMN NewsFeed - 21 Aug 2025
FDA Clearance of Salix(R) Coronary Plaque Module
Devices Cardiology FDA
 HSMN NewsFeed - 20 Aug 2025
CytoSorbents Updates U.S. FDA Regulatory Status of DrugSorb-ATR
Devices FDA
 HSMN NewsFeed - 15 Aug 2025
Precigen Announces Full FDA Approval of PAPZIMEOS (zopapogene imadenovec-drba), the First and Only Approved Therapy for the Treatment of Adults with Recurrent Respiratory Papillomatosis
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Aug 2025
BTL Expands EMFACE(R) Indications with New FDA Clearance for TMJ Dysfunction
Devices FDA
 HSMN NewsFeed - 11 Aug 2025
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Granted FDA Fast Track Designation for NRX-100 for Suicidal Ideation in Patients with Depression, including Bipolar Depression
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 5 Aug 2025
Hemispherian Receives FDA IND Clearance for First-in-Class Glioblastoma Therapeutic, GLIX1
Biopharmaceuticals Oncology FDA
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