Transcatheter Aortic Valve Devices
May 08, 2025
Teleflex Receives FDA 510(k) Clearance to Expand Use of QuikClot Control+™; Edwards Wins FDA Nod for TAVR Use in Asymptomatic Aortic Stenosis; LivaNova Announces Positive 12-Month Results from OSPREY Study in Moderate to Severe OSA; Lipogems Completes Final Patient Visit in ARISE 1 Knee Osteoarthritis Trial; Roche Launches Advanced Elecsys PRO-C3 Test for More Accurate Liver Fibrosis Grading; iRhythm Introduces Zio® Long-Term ECG Monitoring in Japan, Enhancing AI-Driven Arrhythmia Detection
Teleflex Secures FDA 510(k) Clearance for Broader Use of QuikClot Control+™ Hemostatic Device On April 30, 2025, Teleflex Incorporated, a global leader in medical technologies, announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded Indications for Use ...
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Jan 25, 2024
FDA Breakthrough Device Designation to Pi-Cardia’s ShortCut; AbSolutions Med’s REBUILD Bioabsorbable Abdominal Wall Closure Device; AngioDynamics Announces FDA 510(k) Clearance of Auryon XL Radial Access Catheter; Enhatch Announces FDA Clearance for a TKA Patient-Specific Instrumentation System
Pi-Cardia Receives FDA Breakthrough Device Designation for ShortCut™ Pi-Cardia Ltd., a prominent player in advancing catheter-based leaflet modification solutions for heart valve treatment, revealed that its ShortCut™ device has attained Breakthrough Device Designation from the US Food and Drug Administration. S...
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Oct 26, 2023
Cardio Flow’s FreedomFlow Orbital Atherectomy Peripheral Platform; Medtronic’s Aurora EV- ICD System to Treat Arrhythmias; GE Healthcare and Novo Nordisk Announces Collaboration; Olympus’s EVIS X1 Endoscopy System; Medtronic’s Evolut TAVR Platform Outperformed Surgery with Sustained Valve Performance; Abbott’s Minimally Invasive Devices for People with Leaky Heart Valves
Olympus Announced Market Launch of EVIS X1™ Endoscopy System On October 19, 2023, Olympus Corporation, a global medical technology company announced the market launch of its next-generation EVIS X1™ endoscopy system. The GIF-1100 gastrointestinal videoscope indicated for use in the upper digestive tract, and ...
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