Semantics and CBIR: a medical imaging perspective
CIVR '08 Proceedings of the 2008 international conference on Content-based image and video retrieval
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Computer-aided diagnosis (CADx) systems have begun asuccessful transition from academic research tocommercial implementation. FDA approval of CADx forPAP smear reading in 1995 and for breast cancerdetection in 1998 were major milestones in this process.As Agency experience with these devices has increased,a consensus is emerging concerning factors to beconsidered in the evaluation required during theapproval process. Key elements determining the natureof the proof of safety and effectiveness required by theAgency include the intrinsic level of risk associated withthe device and the medical condition that it is meant toaddress, the precise claims made for the device, and thedegree of oversight exercised over its use. The Agencyexpects that an increasing number of CADx devices willbe submitted to it in the future and that guidelines willhave to be formulated to assist manufacturers innavigating the approval process.