The FDA has shared its first draft guidance on how sponsors should assess the credibility of artificial intelligence (AI) models to support FDA decisions regarding drug safety, effectiveness or quality. The agency noted an...more
The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices. The Importance of Engaging Early Sponsors of AI-enabled devices should engage with the...more
This edition of Orrick’s series of life sciences publications reviews fullyear 2020 data in depth to identify and summarize the key trends that shaped venture investment across the sector. 2020 was a banner period for many...more