Medical Device Legal News with Sam Bernstein: Episode 11
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more
On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more
On August 30, 2023, Health Canada opened consultation on its draft pre-market guidance for machine learning-enabled medical devices (MLMD), i.e., medical devices that use machine learning, in whole or in part, to achieve...more
The global AI market was valued at $95.60 billion in 2021 and is predicted to reach $1.85 trillion by 2030, registering a compound annual growth rate of 32.9%. Alongside this growth and the proliferation of AI use cases...more