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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 Feb 2023
FDA approves once-weekly efanesoctocog alfa, a new class of high-sustained factor VIII therapy for haemophilia A: Swedish Orphan Biovitrum AB
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Feb 2023
Zephyrus Innovations announces US FDA approval for its Aeroject(TM) 3ml safety syringe
Devices FDA
 HSMN NewsFeed - 14 Feb 2023
Soligenix Receives Refusal to File Letter from U.S. FDA for HyBryte(TM) New Drug Application in the Treatment of Cutaneous T-Cell Lymphoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 13 Feb 2023
Concept Medical granted Investigational Device Exemption (IDE) approval for their Magic Touch Sirolimus Coated Balloon for the treatment of Below the Knee (BTK) Arterial Disease
Devices Interventional FDA
 HSMN NewsFeed - 8 Feb 2023
CoolHealth Enters U.S. Market With TargetCool(TM), A Breakthrough FDA-Class II Medical Device Offering Unprecedented Precise, Rapid Cooling For Pain Management And Bruise Minimization
Devices Dermatology Product Launch
 HSMN NewsFeed - 6 Feb 2023
Candela Introduces the New FDA-Cleared Profound Matrix(TM) System
Devices Dermatology FDA Product Launch
 HSMN NewsFeed - 2 Feb 2023
Tezspire(R) Approved for Self-Administration in the U.S. with a New Pre-Filled Pen
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 30 Jan 2023
Nanoscope Therapeutics Receives Fast Track Designation by the FDA for MCO-010 for the Treatment of Stargardt Disease
Regenerative Medicine Ophthalmology FDA
 HSMN NewsFeed - 26 Jan 2023
FDA Approves Abbott's Spinal Cord Stimulation for People Living with Painful Diabetic Peripheral Neuropathy
Devices Neurology FDA
 HSMN NewsFeed - 24 Jan 2023
FDA Agrees to Expanded Access Program for the BioVentrix(R) Revivent TC(R) System for the Treatment of Ischemic Heart Failure
Devices Cardiology FDA
 HSMN NewsFeed - 23 Jan 2023
Cadrenal Therapeutics (Nasdaq: CVKD) Granted FDA Fast Track Designation for Tecarfarin for Prevention of Systemic Thromboembolism of Cardiac Origin in Patients with End-Stage Renal Disease and Atrial Fibrillation
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Jan 2023
RenalGuard Therapy(R) Receives FDA Breakthrough Device Designation for Prevention of Cardiac Surgery Associated AKI
Devices Cardiology Surgery FDA
 HSMN NewsFeed - 20 Jan 2023
Astellas Announces Hold Lifted by FDA on FORTIS Clinical Trial of AT845 Investigational Treatment for Adult Patients with Late-Onset Pompe Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Jan 2023
Conventus Flower Orthopedics Announces Expansion of its Flex-Thread(TM) Technology Platform with FDA Clearance of the Ulna Intramedullary Nail System
Devices Orthopaedic FDA
 HSMN NewsFeed - 11 Jan 2023
MedAlliance SELUTION SLR is the first DEB to receive coronary de novo IDE approval, its fourth FDA IDE DEB Approval
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 10 Jan 2023
Arthrex Receives FDA Clearance for TightRope(R) Implant as First, Only Device Cleared for Pediatric ACL Surgery
Devices Orthopaedic FDA
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