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  • Cryoablation Competition Heats Up

    Atrial fibrillation (AF), a common heart rhythm disorder, is often treated with cardiac ablation. Cardiac ablation uses RF (heating) or cryothermal (cooling) energy to scar the areas of the heart muscle that are responsible for the abnormal heart rhythm. Abbott Laboratories, Boston Scientific, and Biosense Webster (a subsidiary of Johnson & Johnson), each offer RF ablation catheters. Acco ...
  • Abbott Obtains FDA Approval for HeartMate 3 Device

    Abbott announced on October 19, 2018 that its HeartMate 3 Left Ventricular Assist Device (LVAD) has received U.S. Food and Drug Administration (FDA) approval as a destination therapy for people living with advanced heart failure. Physicians now can offer the HeartMate 3 system to patients not eligible for a transplant. The HeartMate 3 LVAD can serve as a permanent implant, allowing patients to li ...
  • FDA Approves Marketing of Self-Fitting Hearing Aid

    The U.S. Food and Drug Administration recently announced approval for Bose to market their Bose Hearing Aid.  According to the press release, the Bose Hearing Aid, which was approved through the FDA's De Novo premarket review pathway, is the first approved hearing aid that can be self-fit and adjusted by a user. Malvina Eydelman, M.D., the Director of the Division of Ophthalmic, and Ear, Nos ...
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