On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission ...

On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial ...

In the document, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions," the FDA proposes to ...

On Thursday, the U.S. Department of Health and Human Services announced new funding to help improve the use and maintenance of artificial intelligence-enabled medical devices. Research has shown that ...

The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.

Smart and connected medical devices are transforming healthcare delivery worldwide—making care more accessible, personalized, ...

The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...

On January 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”). The ...

In a transformative era for healthcare, the AI-enabled medical devices market is emerging as a cornerstone of innovation, ...

Medical devices with artificial intelligence (AI), machine learning (ML), and similar “intelligent” systems come with additional layers of quality and regulatory scrutiny. In addition to proof of ...