Regulatory Adoption of AI, ML, Computational Modeling & Simulation in In-Silico Clinical Trials for Medical Devices: A Systematic Review

This study explores the revolutionary potential of in-silico clinical trials (ISCTs) in medical device development, emphasizing the integration of computational modeling and simulation (CM&S), artificial intelligence (AI), and machine learning (ML). It evaluates regulatory advancements by the FD...

Full description

Bibliographic Details

Published in:	Therapeutic innovation & regulatory science
Main Authors:	De, Arindam, Lohani, Alka
Format:	Journal Article
Language:	English
Published:	Switzerland 07.10.2025
Subjects:	USFDA EMA Computer modelling and simulation Medical device Artificial intelligence In-silico clinical trials PMDA
ISSN:	2168-4790, 2168-4804, 2168-4804
Online Access:	Get full text
Tags:	Add Tag No Tags, Be the first to tag this record!