Q4 2024 marked the conclusion of a turnaround year for life sciences venture investment. After two consecutive years of declining activity and macroeconomic uncertainty, the dust has settled, and investment is back on the...more
The DOJ has finalized a set of prohibitions and restrictions on cross-border transfers of certain U.S. data to China and other “Countries of Concern” (for now, Cuba, Iran, North Korea, Russia, and Venezuela), as well as to...more
The FDA has shared its first draft guidance on how sponsors should assess the credibility of artificial intelligence (AI) models to support FDA decisions regarding drug safety, effectiveness or quality.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The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.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
Republished with Permission
In this Law360 article, partners Thora Johnson, Georgia Ravitz and Amy Joseph explore the notable trends to watch in health tech regulation this coming year. The article observes that the...more
Since the previous quarter’s Life Sciences Snapshot, robust dealmaking activity in Q3 has launched YTD life sciences VC deal activity to near parity with 2023 figures, firmly positioning 2024 as the year to break the two-year...more
Generative AI is converging with every sector – and health care is no exception. With it, companies should keep up with the array of laws and regulations – existing and envisioned – that govern its use. Read on for highlights...more