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Therapeutic Innovation & Regulatory Science
|
February 11, 2020
Correction to: A Comprehensive Analysis of Postmarket Surveillance Study Orders: Device Characteristics, Study Statuses, Outcomes, and Potential Contributions
Chie Iwaishi, Kiyotaka Iwasaki
Therapeutic Innovation & Regulatory Science
|
September 7, 2022
Comprehensive Analysis of Clinical Studies and Regulations of Therapeutic Applications in the United States and Japan
Mao Ono, Kiyotaka Iwasaki
Therapeutic Innovation & Regulatory Science
|
January 31, 2020
A Comprehensive Analysis of Postmarket Surveillance Study Orders: Device Characteristics, Study Statuses, Outcomes, and Potential Contributions
Chie Iwaishi, Kiyotaka Iwasaki
Journal of Artificial Organs : the Official Journal of the Japanese Society for Artificial Organs
|
October 7, 2016
Analysis of the safety evaluation for premarketing clinical trials of hemodialyzer and of postmarketing safety reports of hemodialyzer in Japan and the US: insights into the construction of a sophisticated premarketing evaluation
Masami Saito, Kiyotaka Iwasaki
Scientific Reports
|
October 7, 2022
Systematic analysis of the test design and performance of AI/ML-based medical devices approved for triage/detection/diagnosis in the USA and Japan
Mitsuru Yuba, Kiyotaka Iwasaki
ASAIO Journal (American Society for Artificial Internal Organs : 1992)
|
September 2, 2017
Long-Term Durability Test for the Left Ventricular Assist System EVAHEART under the Physiologic Pulsatile Load
Tomoya Kitano, Kiyotaka Iwasaki
PLOS Digital Health
|
March 8, 2023
Performance evaluation methods for improvements at post-market of artificial intelligence/machine learning-based computer-aided detection/diagnosis/triage in the United States
Mitsuru Yuba, Kiyotaka Iwasaki
Journal of Artificial Organs : the Official Journal of the Japanese Society for Artificial Organs
|
March 3, 2022
Biodesign program introduction in Japan: promotion of entrepreneurship and viewpoints of education on medical technology innovation
Koji Nakao, Mitsuo Umezu, Kiyotaka Iwasaki
Journal of Robotic Surgery
|
May 27, 2026
Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system
Hiroyuki Suzuki, Kaoru Hattori, Kiyotaka Iwasaki
Circulation Reports
|
March 11, 2021
Finite Element Analysis of the Cutting Balloon With an Adequate Balloon-to-Artery Ratio for Fracturing Calcification While Preventing Perforation
Xiaodong Zhu, Mitsuo Umezu, Kiyotaka Iwasaki
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Search research articles
Search
Showing results (1-10 of 99) with videos related to
Sort By:
Page
of 10
Therapeutic Innovation & Regulatory Science
|
February 11, 2020
Correction to: A Comprehensive Analysis of Postmarket Surveillance Study Orders: Device Characteristics, Study Statuses, Outcomes, and Potential Contributions
Chie Iwaishi, Kiyotaka Iwasaki
Therapeutic Innovation & Regulatory Science
|
September 7, 2022
Comprehensive Analysis of Clinical Studies and Regulations of Therapeutic Applications in the United States and Japan
Mao Ono, Kiyotaka Iwasaki
Therapeutic Innovation & Regulatory Science
|
January 31, 2020
A Comprehensive Analysis of Postmarket Surveillance Study Orders: Device Characteristics, Study Statuses, Outcomes, and Potential Contributions
Chie Iwaishi, Kiyotaka Iwasaki
Journal of Artificial Organs : the Official Journal of the Japanese Society for Artificial Organs
|
October 7, 2016
Analysis of the safety evaluation for premarketing clinical trials of hemodialyzer and of postmarketing safety reports of hemodialyzer in Japan and the US: insights into the construction of a sophisticated premarketing evaluation
Masami Saito, Kiyotaka Iwasaki
Scientific Reports
|
October 7, 2022
Systematic analysis of the test design and performance of AI/ML-based medical devices approved for triage/detection/diagnosis in the USA and Japan
Mitsuru Yuba, Kiyotaka Iwasaki
ASAIO Journal (American Society for Artificial Internal Organs : 1992)
|
September 2, 2017
Long-Term Durability Test for the Left Ventricular Assist System EVAHEART under the Physiologic Pulsatile Load
Tomoya Kitano, Kiyotaka Iwasaki
PLOS Digital Health
|
March 8, 2023
Performance evaluation methods for improvements at post-market of artificial intelligence/machine learning-based computer-aided detection/diagnosis/triage in the United States
Mitsuru Yuba, Kiyotaka Iwasaki
Journal of Artificial Organs : the Official Journal of the Japanese Society for Artificial Organs
|
March 3, 2022
Biodesign program introduction in Japan: promotion of entrepreneurship and viewpoints of education on medical technology innovation
Koji Nakao, Mitsuo Umezu, Kiyotaka Iwasaki
Journal of Robotic Surgery
|
May 27, 2026
Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system
Hiroyuki Suzuki, Kaoru Hattori, Kiyotaka Iwasaki
Circulation Reports
|
March 11, 2021
Finite Element Analysis of the Cutting Balloon With an Adequate Balloon-to-Artery Ratio for Fracturing Calcification While Preventing Perforation
Xiaodong Zhu, Mitsuo Umezu, Kiyotaka Iwasaki
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of 10