FDA’s AI tool for medical devices struggles with simple tasks

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. The tool — which is still in beta testing — is buggy, doesn’t yet connect to the FDA’s internal systems and has issues when it comes to uploading documents or allowing users to submit questions, the people say. It’s also not currently connected to the internet and can’t access new content, such as recently published studies or anything behind a paywall.