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.
Read MoreFrom the age of 10, Steve Grimes, set his eyes on a career in engineering. Suffice it to say that he made his dreams come true—as Grimes is the 2016 recipient of the Association for the Advancement of Medical Instrumentation’s “HTM Leadership Award.“
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