FDA classifies machine learning imaging software as Class II device
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The Food and Drug Administration has officially classified a specific type of radiological software into Class II. This classification covers imaging tools that use machine learning to analyze medical images, such as calculating heart function metrics like ejection fraction.
Why it matters: This action primarily affects medical device manufacturers who develop radiological imaging software using machine learning. It provides a clearer path to market by establishing special controls for these tools, potentially speeding up access for healthcare providers who use them for patient diagnostics.
Who it affects
- Manufacturers of radiological machine learning-based quantitative imaging software
This final order was issued by the Food and Drug Administration, Health and Human Services Department; readers should check the original Federal Register document for full details on the required special controls.
Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document