Michelle E. Tarver

And you're able to then see kind of the common threads across all of it.

But the regulatory affairs crowd, going back to our FDA town hall with Dr. Michelle Tarver back in April, just a really engaged group.

So we're always really excited to be able to bring those folks together.

You mentioned Mark Rapid, and I wanted to touch on that just because it's one of the newsier issues of the day from last week.

The FDA makes a distinction between general use AI tools like ChatGPT or Claude, and those that use AI to do things like diagnose and treat mental health conditions.

Here's how Michelle Tarver, the director of the FDA's Center for Devices and Radiological Health, described the goal of the meeting in her opening remarks.

And yes, for these purposes, the FDA considers chatbots medical devices.

The FDA has authorized over 1,200 AI-enabled medical devices.

The Galleri blood test made by the company Grail says its device can screen for up to 50 cancers using a single blood draw for those patients 50 and over.

As Michelle Tarver, head of the FDA's Center for Devices and Radiological Health, said:

The concept of blood-based multi-cancer detection tests, such as the one being discussed today, represents a genuinely promising opportunity.

Access to the right diagnostic test at the right time can be truly transformative.

Mr. Seehafer proposed a plan to centralize AI oversight at the health department or in the FDA commissioner's office, raising concerns that decisions would be more influenced by the tech sector than by medical considerations, according to people familiar with the plan who were not authorized to discuss it publicly.

The plan met with resistance from Dr. Michelle Tarver, the top medical devices offering overseeing AI software, savoring leadership from expert scientists with a focus on patient safety.

Dr. Macri, who had been outspoken about the influence of Silicon Valley investors, then got word that health department officials wanted him to fire Dr. Tarver, according to people with knowledge of the matter.

He refused.

Sort of looking at, at FDA, both from the standpoint of whether they have the staff and the leadership, and then second, whether they have the authority, can they do what you think needs to be done, or do we have to look to Congress or other policy to give them the authority to, to make the kinda changes you envision?

So I, I think they have a strong center director in the Center for Devices and Radiological Health, Michelle Tarver, MD, PhD, ophthalmologist, so that's someone who's used to doing procedures.

Mm-hmm.

You know, I joke that I have a clean hands [chuckles] specialty-