Atherectomy Devices
Jun 05, 2025
Guardant Health’s Shield Test Earns FDA Breakthrough Device Status; Reflow Medical Gains FDA De Novo Clearance for Spur Peripheral Stent System; FastWave Medical Achieves First-in-Human Use of Coronary Laser IVL System; BD Initiates Patient Registry to Assess Rotarex™ System in PAD Treatment; Johnson & Johnson Unveiled the KINCISE™ 2 System for Use in Knee and Hip Revision Surgeries; Cardinal Health Launches Single-Device Solution for Real-Time Tracking of Three Vital Signs
Guardant Health Secured FDA Breakthrough Device Designation for Its Shield Multi-Cancer Detection Test On June 03, 2025, Guardant Health, Inc., a precision oncology company, reported that the U.S. Food and Drug Administration (FDA) granted breakthrough device designation to its Shield multi-cancer detectio...
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Nov 07, 2024
Beta Bionics Introduces iLet Bionic Pancreas with Abbott’s FreeStyle Libre 3 Integration; Merit Medical Successfully Acquires Cook Medical’s Lead Management Portfolio; Elixir Medical’s LithiX HC-IVL System Maintains Safety and Efficacy at Six-Month Mark; Philips Launches U.S. Clinical Trial with First Patient Enrolled for New Integrated Device for PAD; FDA Grants iRhythm Technologies 510(k) Clearance for Enhanced Zio AT Device; SeeMedX Submits 510(k) for Cardiac Monitoring System Aiming to Revolutionize Heart Failure Management
Beta Bionics Launched iLet Bionic Pancreas Along With Abbott’s FreeStyle Libre 3 Plus sensor On October 30, 2024, Beta Bionics, Inc., a leader in developing advanced diabetes management solutions, announced the launch of its iLet Bionic Pancreas and its integration with Abbott’s FreeStyle Libre® 3 Plus sen...
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Apr 13, 2023
BD’s Advanced Ultrasound Technology for IV Insertions; Compal Electronics Launched New RFA System AblatePal; Icentia Received Clearance for CardioSTAT; Avation Medical Announced Clearance for the Vivally® System; Cardiovascular Systems’s ECLIPSE Clinical Trial; Bone Biologics Received Approval to for Pilot Trial with NB1 in Spinal Fusion Patients
BD Introduced Advanced Ultrasound Technology for IV Insertions to Help Drive First-Stick Success On April 11, 2023, BD (Becton, Dickinson, and Company), a leading global medical technology company, announced the launch of a new, easy-to-use advanced ultrasound device with a specialized probe designed to provide ...
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