Megan Robertson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Medtech Dive, in “AI in Medtech Is Taking Off. Here Are 4 Trends to Watch in 2025.” (Read the full version – subscription required.)
Following is an excerpt:
Artificial intelligence was a topic of focus for the medical device industry in 2024. …
The Food and Drug Administration recently clarified what information it wants to see in future submissions as the number of AI-enabled devices authorized by the agency has eclipsed 1,000. The FDA still has not authorized any tools that continuously adapt or use generative AI. …
New AI guidance brings clarity to device developers …
Megan Robertson, an attorney with Washington, D.C.-based law firm Epstein Becker Green, said the latest draft guidance is one developers should “keep in your back pocket” and use like a checklist when putting together submissions.
Robertson expects to see more submissions for AI-enabled devices as companies become more familiar with the FDA’s approach. Many products in the agency’s breakthrough device program involve software or AI components, she added.
Related reading:
Megan Robertson cited in Healthtech Curated, “What’s Next for AI in Medtech: Key Trends to Watch in 2025?” by Lukas Hainz.