English  |  正體中文  |  简体中文  |  Post-Print筆數 : 27 |  Items with full text/Total items : 113656/144643 (79%)
Visitors : 51757782      Online Users : 581
RC Version 6.0 © Powered By DSPACE, MIT. Enhanced by NTU Library IR team.
Scope Tips:
  • please add "double quotation mark" for query phrases to get precise results
  • please goto advance search for comprehansive author search
    •  Adv. Search
    Home ‧ Login ‧ Upload ‧ Help ‧ About ‧ Administer Goto mobile version


    Please use this identifier to cite or link to this item: https://nccur.lib.nccu.edu.tw/handle/140.119/112476


    Title: Computer-aided diagnosis in medical imaging: Review of legal barriers to entry for the commercial systems
    Authors: 鄭菀瓊
    Lin, Ting Wei
    Huang, Po Yu
    Cheng, Claire Wan Chiung
    Contributors: 科管智財所
    Keywords: 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
    Date: 2016-11
    Issue Date: 2017-08-31 15:01:06 (UTC+8)
    Abstract: 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.
    Relation: 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
    Data Type: conference
    DOI 連結: http://dx.doi.org/10.1109/HealthCom.2016.7749517
    DOI: 10.1109/HealthCom.2016.7749517
    Appears in Collections:[科技管理與智慧財產研究所] 會議論文

    Files in This Item:

    File Description SizeFormat
    index.html0KbHTML2654View/Open


    All items in 政大典藏 are protected by copyright, with all rights reserved.


    社群 sharing

    著作權政策宣告 Copyright Announcement
    1.本網站之數位內容為國立政治大學所收錄之機構典藏，無償提供學術研究與公眾教育等公益性使用，惟仍請適度，合理使用本網站之內容，以尊重著作權人之權益。商業上之利用，則請先取得著作權人之授權。
    The digital content of this website is part of National Chengchi University Institutional Repository. It provides free access to academic research and public education for non-commercial use. Please utilize it in a proper and reasonable manner and respect the rights of copyright owners. For commercial use, please obtain authorization from the copyright owner in advance.

    2.本網站之製作，已盡力防止侵害著作權人之權益，如仍發現本網站之數位內容有侵害著作權人權益情事者，請權利人通知本網站維護人員(nccur@nccu.edu.tw)，維護人員將立即採取移除該數位著作等補救措施。
    NCCU Institutional Repository is made to protect the interests of copyright owners. If you believe that any material on the website infringes copyright, please contact our staff(nccur@nccu.edu.tw). We will remove the work from the repository and investigate your claim.
    DSpace Software Copyright © 2002-2004  MIT &  Hewlett-Packard  /   Enhanced by   NTU Library IR team Copyright ©   - Feedback