FDA’s AI tool for medical devices struggles with simple tasks
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A new Food and Drug Administration AI tool that could speed up reviews and approvals of medical devices such as pacemakers and insulin pumps is struggling with simple tasks, according to two people familiar with it. Limited time: Save 25% on NBC News subscription Get exclusive reporting, live Q&As and ad-free reading.
AI Summary
Main Idea: The FDA is rolling out AI tools to speed medical device reviews, but its new system is still buggy and not ready for some basic tasks.
Key Points:
- The FDA’s device-review AI, called CDRH-GPT, is in beta and has trouble uploading files, taking questions, and connecting to internal systems.
- The tool is not online and cannot access newer studies or paywalled research, which limits its usefulness for reviews.
- FDA Commissioner Dr. Marty Makary has pushed fast AI adoption across the agency, but some staff and experts say the rollout is moving too quickly.
- Critics warn that AI should only assist human reviewers, since medical device decisions affect patient safety and may raise conflict-of-interest concerns.
Impact on the People
Negative Impact
A buggy FDA AI tool could slow or weaken reviews of pacemakers, insulin pumps, and other devices, raising safety risks for patients.
Positive Impact
FDA AI tools could eventually speed reviews and reduce delays for approved medical devices.
How did each entity affect people?
Rate how each entity in this article affected the American people.
- Primary:Dr. Marty Makaryperson
Candidate Entities7 candidates · 5 weighted vote min · 70% decision
- Dr. Marty MakarypersonPrimaryEvaluated
FDA commissioner whose push for AI and rollout timeline are central to the article.
Include 0 (0%)Ignore 0 (0%)5 to threshold - Center for Devices and Radiological Healthgovernment agency or bodyPrimaryAI selected
FDA division directly responsible for the medical-device review work and the specific AI tool.
Include 0 (0%)Ignore 0 (0%)5 to threshold - Food and Drug Administrationgovernment agency or bodyPrimaryAI selected
Central agency developing and rolling out the AI tools discussed in the article.
Include 0 (0%)Ignore 0 (0%)5 to threshold - Arthur CaplanpersonContextCandidate
Named expert quoted criticizing the pace of the AI rollout and discussing safety concerns.
Include 0 (0%)Ignore 0 (0%)5 to threshold - NYU Langone Medical Centereducational / research institutionContextCandidate
Arthur Caplan’s affiliated institution, identified in the article.
Include 0 (0%)Ignore 0 (0%)5 to threshold - Richard PainterpersonContextCandidate
Named law professor quoted on conflict-of-interest concerns around AI contracting.
Include 0 (0%)Ignore 0 (0%)5 to threshold - University of Minnesotaeducational / research institutionContextCandidate
Richard Painter’s affiliated institution, identified in the article.
Include 0 (0%)Ignore 0 (0%)5 to threshold
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