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Healthcare News Roundup: FDA

 HSMN NewsFeed - 5 May 2021
Genesis Software Innovations Announces FDA 510(k) Clearance For Preview(TM) 3D Shoulder Arthroplasty Planning Software
Devices Orthopaedic FDA
 HSMN NewsFeed - 4 May 2021
Standard Bariatrics(R) Titan SGS Stapling Technology for Sleeve Gastrectomy Receives FDA Clearance
Devices Surgery FDA
 HSMN NewsFeed - 30 Apr 2021
Therapeutic Solutions International Comes to Agreement with FDA on Clinical Trial Design for First Stem Cell Clinical Trial in Chronic Traumatic Encephalopathy (CTE) Patients
Regenerative Medicine FDA
 HSMN NewsFeed - 29 Apr 2021
Cerapedics Announces FDA Breakthrough Device Designation Granted for P-15L Bone Graft for the Treatment of Degenerative Disc Disease
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 29 Apr 2021
Soliton Receives FDA Clearance of Special 510(k)
Devices Dermatology FDA
 HSMN NewsFeed - 27 Apr 2021
Medtronic Receives FDA Breakthrough Designation for the Emprint(TM) Ablation Catheter Kit
Devices FDA
 HSMN NewsFeed - 27 Apr 2021
Medtronic Receives FDA Approval to Launch Clinical Study for Implantable Tibial Neuromodulation Therapy for Bladder Incontinence
Devices Urology FDA
 HSMN NewsFeed - 26 Apr 2021
BD Announces FDA 510(k) Submission for BD Alaris(TM) System
Devices FDA
 HSMN NewsFeed - 22 Apr 2021
Getinge receives US FDA 510(k) clearance for three products, expanding the Servo ventilator platform
Devices FDA
 HSMN NewsFeed - 21 Apr 2021
Medtronic Receives U.S. FDA Approval for Pipeline(TM) Flex Embolization Device with Shield Technology(TM)
Devices Interventional FDA
 HSMN NewsFeed - 21 Apr 2021
Cerus Endovascular Announces IDE Approval from the U.S. FDA to Conduct Clinical Study of the Contour Neurovascular System(TM)
Devices Interventional Neurosurgery FDA
 HSMN NewsFeed - 21 Apr 2021
Johnson & Johnson Vision Receives FDA Clearance and CE Mark for Next-Generation Phacoemulsification Machine, VERITAS(TM) Vision System
Devices Ophthalmology FDA Regulatory
 HSMN NewsFeed - 20 Apr 2021
Zimmer Biomet Receives FDA Clearance for ROSA(R) Partial Knee System for Robotically-Assisted Partial Knee Arthroplasty
Devices Orthopaedic FDA
 HSMN NewsFeed - 19 Apr 2021
Curis Receives FDA Orphan Drug Designation for CA-4948 for the Treatment of AML and MDS
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 12 Apr 2021
U.S. FDA Grants De Novo Clearance for First and Only Artificial Intelligence System for Colonoscopy; Medtronic Launches GI Genius(TM) Intelligent Endoscopy Module
Devices Gastroenterology FDA Product Launch
 HSMN NewsFeed - 12 Apr 2021
Cosmo announces FDA approval of GI Genius(TM) intelligent endoscopy module, its revolutionary Artificial Intelligence device for lesion detection during colonoscopy
Devices Gastroenterology FDA
 HSMN NewsFeed - 9 Apr 2021
Activ Surgical Announces FDA Clearance for ActivSight Intraoperative Imaging Module for Enhanced Surgical Visualization
Devices Surgery FDA
 HSMN NewsFeed - 7 Apr 2021
Chemence Medical Receives FDA Approval for Exofin Fusion(R) Redesign
Devices Surgery FDA
 HSMN NewsFeed - 7 Apr 2021
FDA Approves Bausch & Lomb ClearVisc(TM) Dispersive Ophthalmic Viscosurgical Device
Devices Ophthalmology FDA
 HSMN NewsFeed - 5 Apr 2021
IceCure Medical Granted FDA Breakthrough Device Designation for ProSense(R) Cryoablation System
Devices Oncology FDA
 HSMN NewsFeed - 1 Apr 2021
FDA Grants Breakthrough Therapy Designation for Taiho Oncology's Futibatinib for Treatment of Advanced Cholangiocarcinoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 1 Apr 2021
United Therapeutics Announces FDA Approval and Launch of Tyvaso(R) for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease
Biopharmaceuticals FDA Product Launch
 HSMN NewsFeed - 30 Mar 2021
Biom Therapeutics Receives Orphan Drug Status for BIO017 from the U.S. FDA for the treatment of Angelman Syndrome
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 22 Mar 2021
Oakrum Pharma and Aucta Pharma Announce U.S. FDA Approval of Generic Version of JADENU(R) Sprinkle (Deferasirox Granules)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 18 Mar 2021
Boston Scientific Receives FDA Approval for TheraSphere(TM) Y-90 Glass Microspheres
Devices Oncology FDA
 HSMN NewsFeed - 16 Mar 2021
Imbio Receives FDA 510(k) Clearance for New Cardiothoracic Imaging Algorithm
Devices Cardiology Radiology FDA
 HSMN NewsFeed - 15 Mar 2021
Check-Cap Receives FDA IDE Approval for Pivotal Study of C-Scan(R)
Devices Gastroenterology FDA
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