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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 - 15 Dec 2023
CymaBay Submits New Drug Application to FDA for Seladelpar for the Treatment of Primary Biliary Cholangitis
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Dec 2023
Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101 in the Treatment of Patients With Refractory Myasthenia Gravis
Biopharmaceuticals FDA
 HSMN NewsFeed - 7 Dec 2023
BD Receives FDA 510(k) Clearance for Potentially Transformative Fingertip Blood Collection Device
Devices Diagnostics FDA
 HSMN NewsFeed - 6 Dec 2023
NSite Medical Announces FDA Clearance for Groundbreaking AI-Based Scoliosis Scanning App
Devices FDA
 HSMN NewsFeed - 5 Dec 2023
ABK Biomedical Announces That its Eye90 Microspheres(R) Device Has Been Granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA)
Devices Oncology FDA
 HSMN NewsFeed - 28 Nov 2023
Inflammatix Receives Breakthrough Device Designation from FDA for TriVerity(TM) Acute Infection and Sepsis Test System
Diagnostics FDA
 HSMN NewsFeed - 27 Nov 2023
RTI Surgical Inc. Receives FDA IDE Approval for the Clinical Investigation of Cortiva(R) Allograft Dermis in Breast Reconstruction
Devices Surgery FDA
 HSMN NewsFeed - 22 Nov 2023
Vaccine Partner Valneva receives FDA approval for the World's first chikungunya vaccine using Albumedix' Recombumin(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Nov 2023
FDA Grants Orphan Drug Designation to NeoImmuneTech's NT-I7 for the Treatment of Acute Radiation Syndrome
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Nov 2023
Ad Astra Diagnostics receives 510(k) clearance of QScout(TM) hematology analyzer, the first to report measures of infection and severity at point-of-care
Diagnostics FDA
 HSMN NewsFeed - 14 Nov 2023
FDA Clears Sirius Pintuition(R) for Long-term and Soft Tissue Implantation
Devices Oncology Surgery FDA
 HSMN NewsFeed - 8 Nov 2023
Recor Medical and Otsuka Medical Devices Announce First FDA-Approved Renal Denervation System for the Treatment of Hypertension
Devices Cardiology FDA
 HSMN NewsFeed - 7 Nov 2023
Johnson & Johnson MedTech Provides Details and Timeline for General Surgery Robot
Devices Surgery FDA
 HSMN NewsFeed - 2 Nov 2023
BD Advances "One-Stick Hospital Stay" Vision with Launch of Next-Generation Needle-Free Blood Draw Technology
Devices FDA Product Launch
 HSMN NewsFeed - 31 Oct 2023
FDA Approves Novartis Cosentyx(R) as the First New Biologic Treatment Option for Hidradenitis Suppurativa Patients in Nearly a Decade
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Oct 2023
Centinel Spine(R) PMA Application for First-of-its-Kind 2-Level prodisc(R) C Vivo and prodisc C SK Match-the-Disc(TM) Cervical Total Disc Replacement System Filed and Proceeding with Substantive Review
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 23 Oct 2023
Medtronic receives FDA approval for extravascular defibrillator to treat abnormal heart rhythms, sudden cardiac arrest
Devices Cardiology FDA
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