US health regulators make it easier to approve AI for medical imaging

The US Food and Drug Administration is reclassifying AI software that helps doctors detect and diagnose issues in medical images. This change moves the software into a category with fewer regulatory hurdles, making it faster and cheaper for companies to get these AI tools approved.

For years, getting new medical devices approved in the US has been a slow and expensive process, especially for complex software. This reclassification means that AI tools for radiology can now reach patients faster. It signals a shift in how regulators view and handle AI in healthcare, prioritizing access over the most stringent review processes.