Objective The objective of this study is to examine the current landscape of FDA-approved AI
medical imaging devices and identify trends in clinical validation strategy. Materials and …

AIM To examine the current landscape of US Food and Drug Administration (FDA)-approved
artificial intelligence (AI) medical imaging devices and identify trends in clinical validation …

Rationale and Objectives To assess key trends, strengths, and gaps in validation studies of
the Food and Drug Administration (FDA)-regulated imaging-based artificial …

As applications of AI in medicine continue to expand, there is an increasing focus on
integration into clinical practice. An underappreciated aspect of this clinical translation is …

Abstract Background Intended use statements (IUSs) are mandatory to obtain regulatory
clearance for artificial intelligence (AI)-based medical devices in the European Union. In …

The investigation explores discrepancies in how vendors represent artificial intelligence or
machine learning (AI/ML) capabilities of FDA-cleared products by comparing marketing …

There has been an exponential increase in the number of publications and work pertaining
to applications of artificial intelligence (AI) and machine learning (ML) in medicine and in …

The potential applications of artificial intelligence and machine learning (AI/ML) in medicine
are progressing rapidly. AI is a broad term that refers to the intelligence of computer and …

Purpose To introduce developers to medical device regulatory processes and data
considerations in artificial intelligence and machine learning (AI/ML) device submissions …

Purpose Despite tremendous gains from deep learning and the promise of artificial
intelligence (AI) in medicine to improve diagnosis and save costs, there exists a large …