abnormal heart rhythm News
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Thermedical Announces FDA Breakthrough Device Designation
WALTHAM. Mass.. May 19,2020 - Thermedicak a developer of thermal-ablation medical systems to treat ventricular tachycardia (VT): today announced that it has received Breakthrough Device Designation from the U.S. Food & Drug Administration (FDA) for its Saline Enhanced Radiofrequency (SERF) Ablation system and Durablate® catheter. The FDA Breakthrough Devices Program is intended to help ...
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Boston Scientific Announces Expanded Investment and Exclusive Acquisition Option Agreement with Farapulse, Inc.
Boston Scientific Corporation (NYSE: BSX) today announced it has signed an investment agreement with an exclusive option to acquire Farapulse, Inc., a privately-held company developing a pulsed field ablation (PFA) system for the treatment of atrial fibrillation (AF) and other cardiac arrhythmias. This PFA system – comprising a sheath, generator and catheters – is intended to ablate ...
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Volta Medical’s VX1 AI software for use in atrial fibrillation mapping now FDA cleared
Volta Medical, a pioneering French-based HealthTech startup is pleased to announce that it has obtained FDA clearance for its revolutionary VX1 AI (artificial intelligence) software. This is the first FDA clearance for an AI based tool in interventional cardiac electrophysiology. VX1 is a machine and deep learning-based algorithm designed to assist operators in the real-time manual annotation of ...
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Abbott receives FDA approval for first fully automated blood test for `kissing bug` disease
Abbott received Biologic License Application (BLA) approval from the United States Food and Drug Administration (FDA) for the ABBOTT PRISM Chagas test. The test is a fully automated blood screening assay that can detect antibodies to Trypansoma cruzi (T. cruzi), a parasite found only in the Americas and most commonly acquired through contact with the blood-sucking triatomine or "kissing bug." ...
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FARAPULSE’s Pivotal ADVENT Trial underway with First Patients Treated with its Breakthrough Pulsed Field Ablation System to Treat Atrial Fibrillation
FARAPULSE Inc. today announced the first patients were treated in the ADVENT Trial, a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial to evaluate the safety and effectiveness of its Pulsed Field Ablation (PFA) system for the treatment of paroxysmal Atrial Fibrillation (AF). AF is a heart rhythm disorder that affects nearly 6 million Americans and makes ...
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