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Megan Robertson, an attorney with Washington, D.C.-based law firm Epstein Becker Green, said the latest draft guidance is one developers should “keep in your back pocket” and use like a checklist when putting together submissions.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.

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.