Abstract In the United States, regulatory oversight of medical devices has evolved with the
changing technology. With the introduction into routine clinical practice software applications …

When the US Food and Drug Administration (FDA) cleared the Apple Watch in 2018 for use
in detecting irregular heart rhythms, many observers were worried that the agency would …

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

Regulation of health technologies must be rigorous, instilling trust among both healthcare
providers and patients. This is especially important for the control and supervision of the …

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 …

Artificial intelligence (AI) and Machine learning (ML) systems in medicine are poised to
significantly improve health care, for example, by offering earlier diagnoses of diseases or …

Artificial Intelligence (AI) is becoming increasingly common in healthcare and has potential
to improve the efficiency and quality of healthcare services. As the utility of AI expands …

In fulfilling their duty to regulate the practice of medicine, state medical boards face complex
regulatory challenges and patient safety concerns in adapting regulations and standards for …

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

Given the shortage of caregivers and the increase in an aging US population, the future of
US healthcare quality does not look promising and definitely is unlikely to be cheaper …