A non-invasive software upgrade method for permanent implantable medical devices was developed to alleviate patients＇ suffering due to malfunctions because of software faults,which may cause serious adverse health co...A non-invasive software upgrade method for permanent implantable medical devices was developed to alleviate patients＇ suffering due to malfunctions because of software faults,which may cause serious adverse health consequences or require enhancements with new software.The programs distributed to the internal implantable pulse generator（IPG） from the external programmer have been developed so that the upgrade service program in the IPG is simplified with most complex functions executed by the external programmer.A bidirectional protocol including frame definition and transmission mode was designed to insure secure upgrades.A neuro-stimulator was used to verify the upgrade solution with no additional elements,to maintain the hardware reliability.This study emphasizes how to insure a secure and stable upgrade process and reduce power consumption for special wireless and life safety-critical applications.Tests on rhesus monkeys to evaluate the feasibility of the approach for an IPG used for brain stimulation evaluation show that the software upgrade can be implemented stably with good tolerance to the wireless data transmissions.展开更多
新兴技术的发展,推动数字疗法逐渐流行,软件已成为医疗产品的重要组成部分。根据国际医疗器械监管机构论坛的定义,SaMD(software as a medical device)是指“具有一个或多个医疗用途,且无需医疗器械硬件即可完成预期用途的软件”,但由...新兴技术的发展,推动数字疗法逐渐流行,软件已成为医疗产品的重要组成部分。根据国际医疗器械监管机构论坛的定义,SaMD(software as a medical device)是指“具有一个或多个医疗用途,且无需医疗器械硬件即可完成预期用途的软件”,但由于国内外尚无对其完整全面的评估与监管体系,其监管问题亟须加强监管研究。本文通过介绍SaMD相关概念及政策、人工智能背景下SaMD面临的监管挑战、我国和WHO对数字医疗的管理原则等情况,使读者获悉为加强SaMD审评与监管的思路,以期对完善我国SaMD监管原则提供启示。展开更多
基金Supported in part by the National Key Technology Research andDevelopment Program (No 2009BAI79B03)in part by the National Natural Science Foundation of China (No 60906050/F040604)the Opening Foundation of the State Key Laboratory of Space Medicine Fundamentals and Application (Chinese Astronaut Research and Training Center) (No SMFA09K08)
文摘A non-invasive software upgrade method for permanent implantable medical devices was developed to alleviate patients＇ suffering due to malfunctions because of software faults,which may cause serious adverse health consequences or require enhancements with new software.The programs distributed to the internal implantable pulse generator（IPG） from the external programmer have been developed so that the upgrade service program in the IPG is simplified with most complex functions executed by the external programmer.A bidirectional protocol including frame definition and transmission mode was designed to insure secure upgrades.A neuro-stimulator was used to verify the upgrade solution with no additional elements,to maintain the hardware reliability.This study emphasizes how to insure a secure and stable upgrade process and reduce power consumption for special wireless and life safety-critical applications.Tests on rhesus monkeys to evaluate the feasibility of the approach for an IPG used for brain stimulation evaluation show that the software upgrade can be implemented stably with good tolerance to the wireless data transmissions.
文摘新兴技术的发展,推动数字疗法逐渐流行,软件已成为医疗产品的重要组成部分。根据国际医疗器械监管机构论坛的定义,SaMD(software as a medical device)是指“具有一个或多个医疗用途,且无需医疗器械硬件即可完成预期用途的软件”,但由于国内外尚无对其完整全面的评估与监管体系,其监管问题亟须加强监管研究。本文通过介绍SaMD相关概念及政策、人工智能背景下SaMD面临的监管挑战、我国和WHO对数字医疗的管理原则等情况,使读者获悉为加强SaMD审评与监管的思路,以期对完善我国SaMD监管原则提供启示。
