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Healthcare News Roundup: FDA

 HSMN NewsFeed - 27 May 2021
FDA Grants Micro Interventional Devices, Inc. Breakthrough Device Designation for the MIA(TM)-T Percutaneous Tricuspid Annuloplasty System
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 26 May 2021
Varian Receives FDA "Breakthrough Device Designation" for its Cardiac Radioablation (CRA) System for Treatment of Refractory Ventricular Tachycardia (VT)
Devices Cardiology FDA
 HSMN NewsFeed - 24 May 2021
EndoFresh Obtains FDA 510(k) Clearance for Its Groundbreaking Disposable Digestive Endoscopy System
Devices Gastroenterology FDA
 HSMN NewsFeed - 24 May 2021
FDA Clearance of the Uro-G Completes UroViu Corporation's Suite of Portable, Single-Use, Disposable Cystoscopes
Devices Urology FDA
 HSMN NewsFeed - 19 May 2021
SoftWave Tissue Regeneration Technologies Receives FDA Clearance for Blood Circulation Increase, Minor Aches and Pains Relief and Connective Tissue Activation
Devices FDA
 HSMN NewsFeed - 17 May 2021
AffyImmune Therapeutics' AIC100 Granted Fast Track Designation for Treating Thyroid Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 14 May 2021
FDA Responds to Creative Medical Technology Holdings Regarding Its ImmCelz(R) IND for Stroke Treatment
Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 13 May 2021
Heron Therapeutics Announces U.S. FDA Approval of ZYNRELEF(TM) (HTX-011) for the Management of Postoperative Pain for up to 72 Hours
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 May 2021
FDA Grants Bold Therapeutics' BOLD-100 an Orphan Drug Designation (ODD) in the Treatment of Gastric Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 10 May 2021
THINK Surgical and Ortho Development Announce FDA Clearance for Use of Balanced Knee System and BKS TriMax Implants with TSolution One Total Knee Application Active Robot System
Devices Orthopaedic FDA
 HSMN NewsFeed - 10 May 2021
Olympus Launches Line of Airway Mobilescopes
Devices FDA Product Launch
 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 - 28 Apr 2021
Protalix BioTherapeutics and Chiesi Global Rare Diseases Receive Complete Response Letter for Pegunigalsidase Alfa from FDA
Biopharmaceuticals 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 - 16 Apr 2021
Lilly requests revocation of emergency use authorization for bamlanivimab alone to complete transition to bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.
Biopharmaceuticals 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 - 8 Apr 2021
Crown Aesthetics Proudly Announces New Indication For Treatment Of Neck Wrinkles For FDA-Cleared Microneedling System, SkinPen(R) Precision
Devices Dermatology 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 - 6 Apr 2021
nanoMesh(TM) LLC (a subsidiary of Exogenesis Corporation) Announces Completion Filing of a Second Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA)
Devices Surgery FDA
 HSMN NewsFeed - 5 Apr 2021
IceCure Medical Granted FDA Breakthrough Device Designation for ProSense(R) Cryoablation System
Devices Oncology FDA
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