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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 - 5 Nov 2020
Quansys Biosciences Receives FDA Emergency Use Authorization for its SARS-CoV-2 IgG Antibody Test that Provides Exceptional Clinical Performance
Diagnostics FDA
 HSMN NewsFeed - 3 Nov 2020
FDA Approves Updated Label for Endari(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Nov 2020
Salvia BioElectronics receives FDA Breakthrough Device Designation for innovative neurostimulation solution
Devices Neurology FDA
 HSMN NewsFeed - 2 Nov 2020
Boston Scientific Receives FDA Approval for the Ranger(TM) Drug-Coated Balloon
Devices Interventional FDA Product Launch
 HSMN NewsFeed - 29 Oct 2020
Roche receives FDA approval for the cobas EGFR Mutation Test v2 as the first companion diagnostic test for expanded EGFR TKI therapies in patients with non-small cell lung cancer
Diagnostics Oncology FDA
 HSMN NewsFeed - 29 Oct 2020
Medtronic Expands ENT Portfolio with FDA Clearance of NIM Vital(TM) Next Generation Intraoperative Nerve Monitoring System and Acquisiton of Ai Biomed Corp.
Devices Neurology FDA Mergers & Acquisitions
 HSMN NewsFeed - 28 Oct 2020
Virtual Incision Receives Investigational Device Exemption (IDE) to Initiate Study of First-of-its-Kind MIRA Platform
Devices Surgery FDA
 HSMN NewsFeed - 26 Oct 2020
Helix Receives Expanded Emergency Use Authorization for On-site Unsupervised Self-Collection and Asymptomatic Screening with the Helix(R) COVID-19 Test
Diagnostics FDA
 HSMN NewsFeed - 23 Oct 2020
GI Supply Gets FDA Clearance for its Submucosal Lifting Agent in a Second Size, a Pre-filled 10mL Syringe
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 21 Oct 2020
FDA Grants Fast Track Status to Aegle Therapeutics' AGLE-102 for the Treatment of Dystrophic Epidermolysis Bullosa
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 21 Oct 2020
Acuitive Technologies Granted FDA 510(k) Clearance for CITREGEN(TM) CITRELOCK(TM) Tendon Interference Screw System
Devices Orthopaedic FDA
 HSMN NewsFeed - 21 Oct 2020
Tyber Medical Receives FDA Clearance on Foot and Ankle Plating Systems
Devices Orthopaedic FDA
 HSMN NewsFeed - 20 Oct 2020
Ezra Receives FDA Clearance for Prostate Cancer Artificial Intelligence
Devices Radiology Urology FDA
 HSMN NewsFeed - 14 Oct 2020
Harmony Biosciences Receives FDA Approval For Expanded Use Of WAKIX(R) (pitolisant) For The Treatment Of Cataplexy In Adult Patients With Narcolepsy
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Oct 2020
Varian Receives Investigational Device Exemption (IDE) and Prepares for First Ever Clinical Trial of FLASH Therapy
Devices Oncology FDA
 HSMN NewsFeed - 12 Oct 2020
CartiHeal Receives FDA "Breakthrough Device Designation" for the novel Agili-C Implant
Devices Regenerative Medicine Orthopaedic FDA
 HSMN NewsFeed - 5 Oct 2020
BD Granted FDA 510(k) Clearance for BD FACSLyric(TM) Flow Cytometer with Newly Integrated BD FACSDuet(TM) Sample Preparation System
Diagnostics FDA
 HSMN NewsFeed - 5 Oct 2020
CARsgen Therapeutics Granted Orphan Drug Designation by the US FDA for CT041 CLDN18.2 CAR-T Cells for the Treatment of Gastric and Gastroesophageal Junction Cancers
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 2 Oct 2020
BioMarin, Pioneer in Phenylketonuria (PKU) and Gene Therapy, Receives FDA Fast Track Designation for PKU Investigational Gene Therapy, BMN 307
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Sep 2020
AbbVie Receives Orphan Drug and Fast Track Designations from the U.S. Food and Drug Administration for Elezanumab, an Investigational Monoclonal Antibody RGMa Inhibitor, for the Treatment of Spinal Cord Injury
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 24 Sep 2020
Leap Therapeutics Announces FDA Fast Track Designation Granted to DKN-01 for the Treatment of Gastric and Gastroesophageal Junction Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 22 Sep 2020
NanoVibronix UroShield(R) Receives U.S. Food and Drug Administration Authorization for Entry into the U.S.
Devices FDA
 HSMN NewsFeed - 21 Sep 2020
BD Announces FDA Classifications for August 4th Recalls of BD Alaris(TM) System Hardware for Keypads, Incorrect Module Types and/or Sizes, and Channel Error
Devices Product Recall
 HSMN NewsFeed - 15 Sep 2020
ControlRad(R) Announces FDA Clearance and Closing of Series C Financing
Devices Radiology Venture Capital FDA
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