There has been a surge of interest in artificial intelligence and machine learning (AI/ML)-
based medical devices. However, it is poorly understood how and which AI/ML-based …

Summary The US Food and Drug Administration is clearing an increasing number of
artificial intelligence and machine learning (AI/ML)-based medical devices through the 510 …

Background Machine learning (ML), a type of artificial intelligence (AI) technology that uses
a data-driven approach for pattern recognition, has been shown to be beneficial for many …

Concerns have been raised over the quality of evidence on the performance of medical
artificial intelligence devices, including devices that are already on the market in the USA …

Abstract Introduction Artificial Intelligence-based Medical Devices (AI-based MDs) are
experiencing exponential growth in healthcare. This study aimed to investigate whether …

As artificial intelligence (AI) has been highly advancing in the last decade, machine learning
(ML)-enabled medical devices are increasingly used in healthcare. In this study, we …

Importance The marketing of health care devices enabled for use with artificial intelligence
(AI) or machine learning (ML) is regulated in the US by the US Food and Drug …

Introduction Artificial intelligence (AI) encompasses a wide range of algorithms with risks
when used to support decisions about diagnosis or treatment, so professional and …

At the beginning of the artificial intelligence (AI)/machine learning (ML) era, the expectations
are high, and experts foresee that AI/ML shows potential for diagnosing, managing and …

WHO publishes clinical, public health policy, and data recommendations to advise countries
on health interventions and evidence-based practices for improving the health of individuals …