All Insights Report FDA-Approved Artificial Intelligence and Machine Learning-Enabled Medical Devices: An Updated Landscape From 1995 to 2023

    FDA-Approved Artificial Intelligence and Machine Learning-Enabled Medical Devices: An Updated Landscape From 1995 to 2023

    RWE, HEOR & Evidence Synthesis

    FDA-Approved Artificial Intelligence and Machine Learning-Enabled Medical Devices: An Updated Landscape From 1995 to 2023

    This study explores the landscape of USFDA-approved AI/ML-enabled medical devices, spanning from initial approvals in 1995 to recent breakthroughs in 2023, elucidating their impact on diagnostic accuracy, treatment efficiency, and patient outcomes while addressing regulatory nuances and data gaps.

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    FDA-Approved Artificial Intelligence and Machine Learning-Enabled Medical Devices: An Updated Landscape From 1995 to 2023

    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.

    Contact us at connect@axtria.com with any questions.

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