Computer-aided diagnosis in medical imaging: Review of legal barriers to entry for the commercial systems

摘要: The goal of this paper is to explore whether the premarket regulatory system United States functions ideally in facing emergence commercial computer-aided diagnosis (CAD) systems for medical imaging. To outline CAD available States, clinical trials published PubMed and EMBASE from 2012 2016 that investigated competence products were obtained, product information provided these studies was searched Establishment Registration & Device Listing database, Releasable 510(k) Premarket Notification Approval (PMA) database FDA trace processes through which such entered healthcare market. A review current devices, potential problems may hinder social integration are presented. We noticed expansion definition variation device classes codes among with similar uses, compromise efficacy controls. results suggested ineffectiveness controls States.