Artificial intelligence has been in the spotlight recently, but it is not a new concept to the Food and Drug Administration (FDA) or the medtech industry. AI advancements in the…
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Outlining the facts and dispelling myths will inform policymaking to avoid overlap with current regulations and preserve the broad capacity of innovation to help patients.
This document provides the medical device industry’s foundational principles for artificial intelligence in medical technology. These principles will guide further innovations, policymaking, and regulations in AI-enabled medical technology.
Medical device manufacturers take seriously the need to continuously assess the security of their devices.
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