Japanese guidance for ventricular assist devices/total artificial hearts

Takashi Yamane; Shunei Kyo; Hikaru Matsuda; Yusuke Abe; Kou Imachi; Toru Masuzawa; Takeshi Nakatani; Kazuhiro Sase; Koichi Tabayashi; Setsuo Takatani; Eisuke Tatsumi; Mitsuo Umezu; Toshie Tsuchiya

doi:10.1111/j.1525-1594.2010.01091.x

Japanese guidance for ventricular assist devices/total artificial hearts

Takashi Yamane^*, Shunei Kyo, Hikaru Matsuda, Yusuke Abe, Kou Imachi, Toru Masuzawa, Takeshi Nakatani, Kazuhiro Sase, Koichi Tabayashi, Setsuo Takatani, Eisuke Tatsumi, Mitsuo Umezu, Toshie Tsuchiya

^*Corresponding author for this work

Research output: Contribution to journal › Short survey › peer-review

13 Citations (Scopus)

Abstract

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.

Original language	English
Pages (from-to)	699-702
Number of pages	4
Journal	Artificial Organs
Volume	34
Issue number	9
DOIs	https://doi.org/10.1111/j.1525-1594.2010.01091.x
Publication status	Published - 2010 Sept
Externally published	Yes

Keywords

Evaluation criteria
Guidance
Total artificial heart
Ventricular assist device

ASJC Scopus subject areas

Bioengineering
Medicine (miscellaneous)
Biomaterials
Biomedical Engineering

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10.1111/j.1525-1594.2010.01091.x

Cite this

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abstract = "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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T1 - Japanese guidance for ventricular assist devices/total artificial hearts

AU - Yamane, Takashi

AU - Kyo, Shunei

AU - Matsuda, Hikaru

AU - Abe, Yusuke

AU - Imachi, Kou

AU - Masuzawa, Toru

AU - Nakatani, Takeshi

AU - Sase, Kazuhiro

AU - Tabayashi, Koichi

AU - Takatani, Setsuo

AU - Tatsumi, Eisuke

AU - Umezu, Mitsuo

AU - Tsuchiya, Toshie

PY - 2010/9

Y1 - 2010/9

N2 - 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.

AB - 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.

KW - Evaluation criteria

KW - Guidance

KW - Total artificial heart

KW - Ventricular assist device

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Japanese guidance for ventricular assist devices/total artificial hearts

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

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