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Proceedings Papers

Burst, Leakage, and Constant Pressure Infusion Testing of a Convection Enhanced Drug Delivery System for Glioblastoma Treatment

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Iman Salafian, Christopher G. Rylander
Proc. ASME. DMD2022, 2022 Design of Medical Devices Conference, V001T10A006, April 11–14, 2022
Publisher: American Society of Mechanical Engineers
Paper No: DMD2022-1060
https://doi.org/10.1115/DMD2022-1060
... (branch-out). We are preparing CETCS for regulatory pathway application to advance it further toward clinical and human trials. In this paper, we performed three performance tests: infusion pressure, leakage, and constant pressure flow rate tests required by the FDA to file a traditional 510(K) based upon...
View Paper titled, Burst, Leakage, and Constant Pressure Infusion Testing of a Convection Enhanced Drug Delivery System for Glioblastoma Treatment
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Topics: Catheters, Convection, Drug delivery systems, Fibers, Flow (Dynamics), Food and Drug Administration, Frequency-domain analysis, Leakage, Microneedles, Pressure
Proceedings Papers

Communicating Cybersecurity and Privacy Design Attributes through Privacy Labeling of Consumer Electronic Medical Devices

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Monroe J. Molesky
Proc. ASME. DMD2022, 2022 Design of Medical Devices Conference, V001T03A001, April 11–14, 2022
Publisher: American Society of Mechanical Engineers
Paper No: DMD2022-1045
https://doi.org/10.1115/DMD2022-1045
... to the healthcare field, this research proposes a unique, standardized consumer privacy label for the FDA to implement, mirroring the design and success of the FDA nutrition label in educating consumers in healthy decision making. Device Cybersecurity FDA Consumers Proceedings of the 2022 Design...
View Paper titled, Communicating Cybersecurity and Privacy Design Attributes through Privacy Labeling of Consumer Electronic Medical Devices
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Topics: Computer security, Design, Food and Drug Administration, Frequency-domain analysis, Medical devices
Proceedings Papers

Cardiovascular Medical Devices: Regulatory Science Research Overview in the Office of Science and Engineering Laboratories (OSEL) at the Food and Drug Administration (FDA)

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Kenneth Aycock, Ksenia Blinova, Maura Casciola, Brent Craven, Matthew Di Prima, Gavin D’Souza, Nandini Duraiswamy, Masoud Farahmand, Prasanna Hariharan, Luke Herbertson, Megan Jamiolkowski, Qijin Lu, Richard Malinauskas, Mehulkumar Patel, Jean Rinaldi, Shiril Sivan, Oleg Vesnovsky, Jason Weaver
Proc. ASME. DMD2021, 2021 Design of Medical Devices Conference, V001T02A011, April 12–15, 2021
Publisher: American Society of Mechanical Engineers
Paper No: DMD2021-1085
https://doi.org/10.1115/DMD2021-1085
... Abstract The Cardiovascular Research Program in OSEL at the FDA consists of a diverse group of engineers and scientists who seek to drive innovation in cardiovascular device technology through development and standardization of pre-clinical test methods using in vitro, in vivo, and in silico...
View Paper titled, Cardiovascular Medical Devices: Regulatory Science Research Overview in the Office of Science and Engineering Laboratories (OSEL) at the Food and Drug Administration (FDA)
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Topics: Cardiovascular system, Engineering laboratories, Food and Drug Administration, Medical devices