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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 Dec 2020
Interscope Announces FDA De Novo Marketing Authorization of the EndoRotor(R) System for Direct Endoscopic Necrosectomy (DEN)
Devices Surgery FDA
 HSMN NewsFeed - 23 Dec 2020
FDA Approves Bracco Diagnostics Inc.'s ProHance(R) (Gadoteridol) Injection, 279.3 mg/mL, for Pediatric Patients Younger than Two Years
Biopharmaceuticals Radiology FDA
 HSMN NewsFeed - 22 Dec 2020
Nephron Announces FDA Approval of Ketorolac, Signaling New Phase of Growth
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 21 Dec 2020
Anixa Biosciences and Cleveland Clinic Announce FDA Clearance to Initiate Clinical Trial of Breast Cancer Vaccine
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 21 Dec 2020
Moebius Medical Announces FDA Clearance of IND Application for Phase IIb Clinical Trial of MM-II, a Novel Treatment for Knee Osteoarthritis Pain
Biopharmaceuticals Orthopaedic FDA
 HSMN NewsFeed - 18 Dec 2020
Arthrex Launches First FDA-Cleared ACL Primary Repair Kit
Devices Orthopaedic FDA Product Launch
 HSMN NewsFeed - 18 Dec 2020
Occlutech's Atrial Flow Regulator (AFR) Receives U.S. FDA Breakthrough Device Designation
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 18 Dec 2020
Polaryx Therapeutics Receives Both Rare Pediatric Disease and Orphan Drug Designations for the Treatment of Niemann Pick Disease Types A and B With PLX-300
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 17 Dec 2020
FDA Approves GSK's BENLYSTA as the First Medicine for Adult Patients with Active Lupus Nephritis in the US
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Dec 2020
FDA Clears Fever-Detecting Vital Data Sensor in New Cardiac MonitorFDA Clears Fever-Detecting Vital Data Sensor in New Cardiac Monitor
Devices Monitoring Cardiology FDA
 HSMN NewsFeed - 16 Dec 2020
Medtronic Strengthens Leadership in Navigated, Robotic Spine Surgery with FDA Clearance of Midas Rex(TM) Drills and Navigated Disc Prep and Interbodies for U.S. with Mazor(TM) Robotic Guidance System
Devices FDA
 HSMN NewsFeed - 15 Dec 2020
Almirall announces FDA approval of Klisyri(R) (tirbanibulin), a new innovative topical treatment for actinic keratosis
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 10 Dec 2020
FDA Approves Novadoz Pharmaceuticals Toremifene and Aminocaproic Acid, Bolstering their Continued Growth in Generics
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 10 Dec 2020
ReCor Medical Announces Positive Results in RADIANCE-HTN TRIO Study and Breakthrough Device Designation for Paradise(TM) Ultrasound Renal Denervation System
Devices Cardiology FDA
 HSMN NewsFeed - 9 Dec 2020
Mesa Biotech Receives 510(k) Clearance and CLIA Waiver for Its Accula(TM) Strep A Molecular Point of Care Test
Diagnostics FDA
 HSMN NewsFeed - 8 Dec 2020
Amgen's Sotorasib Granted Breakthrough Therapy Designation for Advanced or Metastatic Non-Small Cell Lung Cancer Patients with KRAS G12C Mutation
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 1 Dec 2020
Novartis announces FDA approval of Xolair(R) (omalizumab) for adults with nasal polyps
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Nov 2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Extension of PDUFA Date for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Nov 2020
Eiger BioPharmaceuticals Announces FDA Approval of Zokinvy(TM) (lonafarnib): The First Treatment for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Nov 2020
FDA Clears First of its Kind Algorithm Suite for Personal ECG
Devices Monitoring Cardiology FDA
 HSMN NewsFeed - 20 Nov 2020
FDA grants Emergency Use Authorisation for baricitinib in hospitalised COVID-19 patients nine months after initial hypothesis was published by BenevolentAI
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Nov 2020
THINK Surgical(R) Receives FDA Clearance of Second-Generation Active Robot
Devices Orthopaedic Surgery FDA
 HSMN NewsFeed - 19 Nov 2020
LimaCorporate Announces FDA Approval for an IDE Study on SMR Stemless Reverse Shoulder System
Devices Orthopaedic FDA
 HSMN NewsFeed - 17 Nov 2020
Allotrope Medical Announces FDA Clearance of StimSite(TM)
Devices Surgery FDA
 HSMN NewsFeed - 17 Nov 2020
Corvia Medical Completes Randomization In REDUCE LAP-HF II Pivotal Trial And Gains FDA Authorization To Provide Continued Access For The Corvia Atrial Shunt
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 17 Nov 2020
SafKan Health Announces FDA 510(k) Clearance for First-of-its-Kind OtoSet(TM) Ear Cleaning System
Devices FDA
 HSMN NewsFeed - 11 Nov 2020
Nanowear Receives FDA 510(k) Clearance for SimpleSENSE, a Cloth-Based Wearable Remote Diagnostic Monitoring Platform
Devices Monitoring FDA
 HSMN NewsFeed - 10 Nov 2020
icotec ag Receives FDA Clearance for the VADER(R) Pedicle - System with Bone Cement Augmentation
Devices Orthopaedic Neurosurgery FDA
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