2020
DOI: 10.1038/s41746-020-00324-0
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The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database

Abstract: 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 treating a wide variety of medical conditions. However, the obstacles for implementation of AI/ML in daily clinical practice are numerous, especially regarding the regulation of these technologies. Therefore, we provide an insight into the currently available AI/ML-based medical devices and algorithms that have been approved by th… Show more

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Cited by 697 publications
(471 citation statements)
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References 22 publications
(16 reference statements)
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“…Dozens of companies have obtained US FDA and European CE approval for medical imaging AI 37 , and commercial markets have begun to form as sustainable business models are created. For instance, regions of high-throughput healthcare, such as India and Thailand, have welcomed the deployment of technologies such as diabetic retinopathy screening systems 38 .…”
Section: Medical Imagingmentioning
confidence: 99%
“…Dozens of companies have obtained US FDA and European CE approval for medical imaging AI 37 , and commercial markets have begun to form as sustainable business models are created. For instance, regions of high-throughput healthcare, such as India and Thailand, have welcomed the deployment of technologies such as diabetic retinopathy screening systems 38 .…”
Section: Medical Imagingmentioning
confidence: 99%
“…Artificial intelligence-based technologies are rapidly evolving into applicable medical solutions and are actually revolutionizing the field (11). However, only few studies have been put effort to fulfill rigorous regulation standards to be approved by regulatory institutions such as the FDA (12). Most of these approved technologies were developed for the fields of radiology, cardiology and internal medicine.…”
Section: Introductionmentioning
confidence: 99%
“…One day, the use of AI may help to diagnose and even predict the occurrence of sport related injuries [ 26 ]. However, as of today, AI-based chatbots still appear to lag behind other algorithms using machine learning since natural language processing is still a complicated issue and most FDA approved AI-based medical technologies do not use it [ 27 ].…”
Section: Discussionmentioning
confidence: 99%