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Journal Articles

Generating Appropriate and Reliable Evidence for Value Assessment of Medical Devices: An ISPOR Medical Devices and Diagnostics Special Interest Group Report

Nneka C. Onwudiwe, Richard Charter, Bruce Gingles, Payam Abrishami, Henry Alder, Ameet Bahkai, Diane Civic, Melodi Kosaner Kließ, Chantale Lessard, Carla L. Zema
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Expert View
J. Med. Devices. September 2022, 16(3): 034701.
Paper No: MED-20-1229
https://doi.org/10.1115/1.4053928
Published Online: April 12, 2022
View Article titled, Generating Appropriate and Reliable Evidence for Value Assessment of Medical Devices: An ISPOR Medical Devices and Diagnostics Special Interest Group Report
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Topics: Medical devices, Safety, Performance, Design
Journal Articles

Diagnostics as the Key to Advances in Global Health: Proposed Methods for Making Reliable Diagnostics Widely Available

David Melander, Sudesh Sivarasu, Ibrahim Yekinni, Cheng Yunzhang, Arthur Erdman
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Expert View
J. Med. Devices. March 2020, 14(1): 014702.
Paper No: MED-19-1129
https://doi.org/10.1115/1.4046046
Published Online: February 5, 2020
View Article titled, Diagnostics as the Key to Advances in Global Health: Proposed Methods for Making Reliable Diagnostics Widely Available
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Topics: Diseases, Governments, Health care, Health systems, Testing, Non-governmental organizations, Performance, Biomedicine
Journal Articles

Functional Requirements and Quality Assurance Necessary for Successful Incorporation of Electroporation-Based Therapies Into Clinical Practice

Eva Pirc, Matej Reberšek, Damijan Miklavčič
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Expert View
J. Med. Devices. March 2020, 14(1): 014701.
Paper No: MED-19-1150
https://doi.org/10.1115/1.4045837
Published Online: January 31, 2020
View Article titled, Functional Requirements and Quality Assurance Necessary for Successful Incorporation of Electroporation-Based Therapies Into Clinical Practice
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Topics: Electroporation, Patient treatment, Biomedicine, Quality control, Electrodes, Safety
Journal Articles

Children and Adults With Rare Diseases Need Innovative Medical Devices

Vasum Peiris, Kui Xu, Heather L. Agler, Eric A. Chen, Rashmi Gopal-Srivastava, Brian M. Lappin, Debra Y. Lewis, Gayatri R. Rao
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Expert View
J. Med. Devices. September 2018, 12(3): 034701.
Paper No: MED-18-1024
https://doi.org/10.1115/1.4040489
Published Online: July 13, 2018
View Article titled, Children and Adults With Rare Diseases Need Innovative Medical Devices
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Topics: Biomedicine, Diseases, Medical devices, Pediatrics, Food and Drug Administration
Journal Articles

Food and Drug Administration's Humanitarian Device Exemption Marketing Approval Pathway: Insights for Developing Devices for Rare Diseases

Gumei Liu, Eric Chen, Debra Lewis, Gayatri Rao
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Expert View
J. Med. Devices. September 2017, 11(3): 034701.
Paper No: MED-16-1350
https://doi.org/10.1115/1.4036333
Published Online: June 27, 2017
View Article titled, Food and Drug Administration's Humanitarian Device Exemption Marketing Approval Pathway: Insights for Developing Devices for Rare Diseases
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Topics: Diseases, Drugs, Food and Drug Administration, Food products, Safety, Medical devices