How medical AI devices are evaluated: limitations and recommendations from an analysis of
FDA approvals | Nature Medicine Skip to main content Thank you for visiting nature.com. You …

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 US law generally requires testing of high-risk medical devices prior to approval,
as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring …

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 …

Artificial intelligence (AI) systems are increasingly being investigated in clinical trials. Trials
that use AI must be held to the same ethical standards for risk assessment and disclosure as …

Artificial intelligence–and machine learning (AI/ML)–basedtechnologiesaimtoimprovepatientcar…
by an individual patient and by the collective experience ofmanypatients …

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 …

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 …

The European Union has introduced stricter provisions for medical devices under the new
Medical Device Regulation (MDR). The MDR increases requirements for clinical trial testing …

As with new drugs, the US Food and Drug Administration's approval process is intended to
provide consumers with assurance that, once it reaches the market place, a medical device …