Artificial intelligence (AI) and machine learning (ML) represent significant advancements in computing, building on technologies that humanity has developed over millions of years-from the abacus to quantum computers. These tools have reached a pivot...
The regulatory environment in the United States has not kept pace with the rapidly developing market for artificial intelligence (AI)-enabled devices. The number of AI-enabled devices has increased year after year. All of these devices are registered...
Over the past decade, machine learning (ML) and artificial intelligence (AI) have become increasingly prevalent in the medical field. In the United States, the Food and Drug Administration (FDA) is responsible for regulating AI algorithms as "medical...
The US Food and Drug Administration (FDA) regulatory process often involves several reviewers who focus on sets of information related to their respective areas of review. Accordingly, manufacturers that provide submission packages to regulatory agen...
Journal of biomolecular structure & dynamics
Aug 1, 2024
The latest variant of coronavirus is omicron. The World Health Organization (WHO) designated variation 'B.1.1.529' named omicron as a variant of concern (VOC) on 26 November 2021. By September 2020, it will have infected over 16 million patients and ...
Animal testing is required in drug development research and is crucial for assessing the efficacy and safety of medications before they are commercialized. However, the newly furnished Food and Drug Administration Modernization Act 2.0 has given new ...
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(k) pathway. This pathway allows clearance if the device is substantially equivalent to ...
Artificial intelligence (AI) techniques are currently harnessed to revolutionize the domain of medical imaging. This review investigates 3 major AI-driven approaches for contrast agent management: new frontiers in contrast agent dose reduction, the c...
A Food and Drug Administration (FDA)-cleared artificial intelligence (AI) algorithm misdiagnosed a finding as an intracranial hemorrhage in a patient, who was finally diagnosed with an ischemic stroke. This scenario highlights a notable failure mode ...