- FDA releases new guidance on a list of AI tools that should be regulated as medical devices.
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FDA releases new guidance on a list of AI tools that should be regulated as medical devices.
Artificial intelligence (AI) has the potential to significantly improve the medical field by streamlining research and assisting doctors in making a more informed judgment, yet it is looked at with an eye of suspicion and comes with heavy regulations. AI and machine learning (ML) have found growing use in medical devices in recent years due to their ability to “learn” from experience and steadily improve their effectiveness. This article discusses the newly released Food and Drug Administration (FDA) guidance recommending that certain artificial intelligence (AI) tools should be regulated as medical devices as part of the agency’s oversight of clinical decision support (CDS) software.
Source: Health IT Analytics