Podcast: How Do You Protect Yourself When Your AI Makes Mistakes?
Medtech Insight spoke with Sidley Austin attorneys about the future of medical device AI negligence litigation and what manufacturers can do to protect themselves.
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In this roundup feature focusing on developments in digital health, Medtech Insight highlights interviews with Medtronic, Abbott and Congenica, partnerships and launches, and AI and cybersecurity announcements from November.
The agency published minutes from three MDUFA V user fee meetings with medtech industry. The talks include conversations about carryover funds and filling FTEs from past user fee deals.
The number of PMA and 510(k) applications have been steadily growing and becoming harder to review as they’ve become more complex – which an FDA official says means the agency needs more financial resources.