FDA Posts New Draft Guidance on Computer-Assisted Detection Devices Applied to Radiological Images and Radiological Data (CADe) :: Medical Connectivity

This is an interesting summary of an extremely complex document describing what appears to be a modification to the FDA’s classification of devices which might have a substantial impact on our prediction technologies.

All of the detail relates to radiology technologies, in which case it doesn’t relate to what we’re doing (as yet any way). BUT it does say:

“computerized systems that incorporate pattern recognition and data analyses capabilities (i.e. combine values, measurements or features extracted from the patient radiological data) intended to identify, mark, highlight, or in any other manner direct attention to -“

so that is certainly where we’re at – “recognising patterns” and “directing attention to”.

Maybe this impacts on our application for approval?

It may be helpful to compare these new guidances with the pending MDDS rule, discussed here, in which the proposed rule defines an MDDS as Class I, the class with the lowest FDA scrutiny. Unlike MDDS, in the current case these CADe devices are not newly defined. However the FDA does acknowledge that the terminology may not widely known or used. A CADe system is not in the same class as an MDDS, and therefore is not an MDDS, because of the degree to which it analyzes medical device data.

The Federal Register posting defines CADe’s as “computerized systems that incorporate pattern recognition and data analyses capabilities (i.e. combine values, measurements or features extracted fro the patient radiological data) intended to identify, mark, highlight, or in any other manner direct attention to portions of the an image, or aspects of radiology data, that may reveal abnormalities during interpretation of patient radiology images or patient radiology device data by the intended user (i.e., a physician or other health care professional)”. As with the MDDS rule, it can be helpful to know what is excluded from the category as well as what is included. Here certain types of systems are defined to not be CADe. These include:

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