Recent advancements in artificial intelligence (AI) and machine learning (ML) have transformed medical devices, leading to a surge in U.S. Food and Drug Administration (USFDA) approvals for AI/ML-enabled technologies. This rise is driven by AI/ML's ability to improve diagnostic accuracy, treatment efficiency, and patient outcomes, supported by technological advancements, regulatory support, and growing patient acceptance. The USFDA maintains an updated list of these devices for public access. Understanding the evolution, regulatory landscape, and data gaps of AI/ML-enabled medical device approvals is vital for healthcare professionals, regulatory bodies, and industry stakeholders.
This study analyzes the landscape of USFDA-approved AI/ML-enabled medical devices, tracing their development from early approvals in 1995 to recent breakthroughs in 2023.Data on all AI/ML-enabled devices approved from 1995 to July 2023 were extracted from the USFDA database, including information on approval dates, indication types, approval types, device classes, intended uses, algorithm types, and mobile applications. Descriptive statistics were used to analyze the data, offering insights into approval trends and practical applicability in healthcare.
This report is a poster presentation of Axtria from ISPOR 2024.
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