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  • 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 ...
  • FDA & DHS Coordinate Efforts to Address Cybersecurity

    The U.S. Food and Drug Administration (FDA) announced an agreement with the U.S. Department of Homeland Security (DHS) to strengthen the partnership between the agencies and “stay a step ahead of constantly evolving medical device cybersecurity vulnerabilities.” The agreement formalizes a long-standing relationship by developing a new framework for greater coordination and cooperation. As ...
  • Benchmarking Quality Assurance

    Best Practices, LLC recently released a study that provides insights into the amount of resources pharmaceutical and medical device companies allocate to ensure their products meet quality and regulatory standards.  The study includes aggregate and anonymized data from 31 large medical companies, including Fisher & Paykel Healthcare, ResMed, Smith & Nephew, and Medtronic, among others.  ...
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