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According to FDA officials, the agency will be more closely evaluating the potential for certain materials to cause immune/inflammatory reactions in a small number of patients to improve understanding of materials, help uncover ways to identify patients predisposed to these reactions, and improve the overall safety and performance of medical devices.
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The European Union has instituted a proposal to boost cooperation among EU member states for assessing healthcare technologies. After all, EU officials say, more assessments could lead to effective, innovative health tools reaching patients faster.
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The U.S. FDA and the Department of Defense’s (DoD) Office of Health Affairs announced the launch of a joint program to prioritize the efficient development of safe and effective medical products intended to save the lives of American military personnel.
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The U.S. FDA has announced that it will permit marketing of the first product—an electric stimulation device dubbed the NSS-2 Bridge—for use in helping to reduce the symptoms of opioid withdrawal. This device is developed by Versailles, Ind.-based Innovative Health Solutions, Inc.
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