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    題名: Computer-aided diagnosis in medical imaging: Review of legal barriers to entry for the commercial systems
    作者: 鄭菀瓊
    Lin, Ting Wei
    Huang, Po Yu
    Cheng, Claire Wan Chiung
    貢獻者: 科管智財所
    關鍵詞: Biomedical equipment;Competition;Database systems;Diagnosis;Medical imaging;Medical problems;Search engines;510(k);Clinical competence;Computer aided detection;Computer Aided Diagnosis(CAD);Health care markets;legal barriers to entry;premarket approval;Product information;Computer aided diagnosis
    日期: 2016-11
    上傳時間: 2017-08-31 15:01:06 (UTC+8)
    摘要: The goal of this paper is to explore whether the premarket regulatory system of the United States functions ideally in facing the emergence of commercial computer-aided diagnosis (CAD) systems for medical imaging. To outline the commercial CAD systems available in the United States, clinical trials published in PubMed and EMBASE from 2012 to 2016 that investigated the clinical competence of commercial CAD products were obtained, and the product information provided in these studies was searched in the Establishment Registration & Device Listing database, the Releasable 510(k) Premarket Notification database, and the Premarket Approval (PMA) database of the FDA to trace the processes through which such CAD systems entered the healthcare market. A review of current premarket regulatory system for medical devices, and the potential problems that may hinder the social and clinical integration of CAD systems are presented. We noticed expansion of regulatory definition and variation of device classes and product codes among CAD systems with similar clinical uses, which may compromise the efficacy of such regulatory controls. The results suggested ineffectiveness of current premarket regulatory controls for CAD systems in the United States.
    關聯: 2016 IEEE 18th International Conference on e-Health Networking, Applications and Services, Healthcom 2016
    18th IEEE International Conference on e-Health Networking, Applications and Services, Healthcom 2016; Munich; Germany; 14 September 2016 到 17 September 2016
    資料類型: conference
    DOI: http://dx.doi.org/10.1109/HealthCom.2016.7749517
    顯示於類別:[科技管理與智慧財產研究所] 會議論文

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