Scott Gottlieb, commissioner of the Food and Drug Administration, announced the release of a discussion paper as the agency considers developing new regulatory framework to advance the development of artificial intelligence-based medical devices. “We
MoreThe Food and Drug Administration has released a draft guidance to provide recommendations that seek to help companies address cyber risks in medical devices prior to the submission of premarket applications for
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The Food and Drug Administration has issued a final set of guidelines meant to help manufacturers secure medical devices from postmarket cyber vulnerabilities. Suzanne Schwartz, associate director for science and strategic partnerships at the
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Lloyd McCoy Jr., a market intelligence manager at immixGroup, has said the Defense Departmentâs budget request for fiscal year 2017 contains health information technology initiatives that would prioritize the deployment of a
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The Food and Drug Administration has released draft guidance to help manufacturers protect medical devices against cyber threats throughout the product lifecycle. The guide outlines postmarket strategies for the medical device industry to
MoreBruce Andrews, deputy secretary at the Commerce Department, is scheduled to visit Lima, Peru, in March for a three-day trade and investment mission to help U.S. healthcare technology and service industry executives
MoreThe U.S. Food and Drug Administration recommends that cybersecurity measures become an inherent part of medical device design and development in the recently released final guidance for device manufacturers on cybersecurity risk management.
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