The FDA Takes the First Step Toward Regulating Generative AI Medical Devices

Nick Lanyi
0:02

The FDA takes a first step to regulate medical devices that use generative AI and says robot blood draws are A-OK. And a look at a new proficiency testing program for reticulocytes. These stories and more coming up next. This is Path News Network daily edition from the College of American Pathologists. I'm Nick Lanyi. It's Tuesday, August 25th. The FDA is seeking feedback about regulating medical devices that use generative AI technology. In pathology today, most applications that use artificial intelligence aren't based on the generative version. For example, AI now can help analyze digital slides, but it doesn't generate answers based on multiple sources of data like ChatGPT and Claude. But in the near future, so-called copilots using generative AI could summarize multiple slides from a case or make suggestions about next steps toward a diagnosis. The FDA paper does not propose specific rules, but it introduces a possible regulatory framework based in part on whether the device gives directions or acts autonomously. The CAP plans to respond to the FDA's request by the October 19th deadline. In more FDA news, the agency approved the first standalone robotic blood draw device in the U.S. As we told you in June, the Aletta, made by Dutch medical equipment company Vitestro, draws blood from a patient's arm without a human operator. It uses infrared light, ultrasound, and AI to detect veins and direct the needle. The FDA approved the device for adult patients, but only if a trained technician oversees no more than three Aletta devices at a time. Robots could address the long-standing shortage of phlebotomists in the U.S. Now who's ready to go first? As part of our series on the CAP's new crop of proficiency testing programs, which are now available to order, we focus today on the reticulocyte RT5 proficiency test. It is designed to test a laboratory's proficiency at evaluating reticulocyte levels in the blood using automated hematology analyzers made by Mindray, the fast-growing Chinese biomedical equipment maker. Reticulocytes are young, immature red blood cells. Checking their levels is common because it helps diagnose anemia, bone marrow failure, and iron deficiency, among other issues. The CAP created the new RT5 proficiency program for labs that use Mindray machines, which are increasingly used in other countries, although they aren't yet approved in the U.S. Dr. Olga Pozdnyakova, professor of pathology and laboratory medicine at the University of Pennsylvania and chair of the CAP's Hematology /Clinical Microscopy Committee, explained why the growing number of labs using Mindray equipment should consider this new program.

Dr. Olga Pozdnyakova
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It's much easier to participate in a, I don't know, for the lack of the better word, a very well-regulated and organized proficiency testing group, which is College of American Pathology is, uh, than to uh come up with some homegrown uh testing methodology. Uh so it's I think it's better for for the labs because it makes it easier for the labs. They don't need to think about what they need they need to do, but it's also better for patient care because now they're uh so they can compare their performance to a much wider network, to a much wider peer group, which basically that that's what we do. That's how we uh judge our performance and decide whether we're performing on par with our peers or whether we're lagging behind or we're having some problems.

Nick Lanyi
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And finally, the CAP is starting a quarterly webinar series for members only. The first will be held next Wednesday, September 2nd at 1 p.m. Eastern Time. It's called Opportunities and Challenges, a CAP Update. You'll hear timely updates on the state of pathology, including advocacy priorities, along with time for Q&A. Go to the CAP website for more information and to register. That's all for today. Check the show notes for more information on today's stories. And if you enjoyed this episode, share it on social media. We'll be back Wednesday at 5 a.m. Eastern for another episode of the Daily Edition. I'm Nick Lanyi. Have a wonderful day.