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Use of Two Intracorporeal Ventricular Assist Devices As a Total Artificial Heart
Published on: May 11, 2018
Japanese guidance for ventricular assist devices/total artificial hearts
Takashi Yamane1, Shunei Kyo, Hikaru Matsuda
1National Institute of Advanced Industrial Science and Technology, Tsukuba, Japan. yamane.t@aist.go.jp
None:
To facilitate research and development (R&D) and to expedite the review processes of medical devices, the Ministry of Health, Labor and Welfare (MHLW) and the Ministry of Economy, Trade and Industry (METI) founded a joint committee to establish guidance for newly emerging technology. From 2005 to 2007, two working groups held discussions on ventricular assist devices and total artificial hearts, including out-of-hospital programs, based on previous guidance documents and standards. Based on this discussion, the METI published the R&D Guidelines for innovative artificial hearts in 2007, and in 2008 the MHLW published a Notification by Director regarding the evaluation criteria for emerging technology.
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