The reimbursement of artificial intelligence (AI)–based medical devices (MDs) is a complex
and challenging issue, depending on national market access pathways. We aim to analyze …

Objectives The reimbursement of artificial intelligence-based medical devices is a complex
and challenging issue depending on national market access pathways. We aim to analyze …

Objectives Understanding country-specific reimbursement processes and the evidence
requirements of payers and stakeholders is essential for the success of new medical devices …

There are now over 500 medical artificial intelligence (AI) devices that are approved by the
US Food and Drug Administration. However, little is known about where and how often …

With the increasing number of FDA-approved artificial intelligence (AI) systems, the
financing of these technologies has become a primary gatekeeper to mass clinical adoption …

Despite the widespread enthusiasm for artificial intelligence (AI) in health care, adoption of
AI-enabled clinical-decision support software (CDS) that supports the detection, diagnosis …

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 …

Artificial intelligence (AI) is seen as a strategic lever to improve access, quality, and
efficiency of care and services and to build learning and value-based health systems. Many …

Background Several studies highlight the effects of artificial intelligence (AI) systems on
healthcare delivery. AI-based tools may improve prognosis, diagnostics, and care planning …

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 …