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 c...

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Autores principales:	Stan Benjamens, Pranavsingh Dhunnoo, Bertalan Meskó
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2020
Materias:	Computer applications to medicine. Medical informatics R858-859.7
Acceso en línea:	https://doaj.org/article/57ebc19d581944ad8bbd6b42f5de1019
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spelling	oai:doaj.org-article:57ebc19d581944ad8bbd6b42f5de10192021-12-02T14:58:42ZThe state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database10.1038/s41746-020-00324-02398-6352https://doaj.org/article/57ebc19d581944ad8bbd6b42f5de10192020-09-01T00:00:00Zhttps://doi.org/10.1038/s41746-020-00324-0https://doaj.org/toc/2398-6352Abstract 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 the US Food & Drugs Administration (FDA). We aimed to raise awareness of the importance of regulatory bodies, clearly stating whether a medical device is AI/ML based or not. Cross-checking and validating all approvals, we identified 64 AI/ML based, FDA approved medical devices and algorithms. Out of those, only 29 (45%) mentioned any AI/ML-related expressions in the official FDA announcement. The majority (85.9%) was approved by the FDA with a 510(k) clearance, while 8 (12.5%) received de novo pathway clearance and one (1.6%) premarket approval (PMA) clearance. Most of these technologies, notably 30 (46.9%), 16 (25.0%), and 10 (15.6%) were developed for the fields of Radiology, Cardiology and Internal Medicine/General Practice respectively. We have launched the first comprehensive and open access database of strictly AI/ML-based medical technologies that have been approved by the FDA. The database will be constantly updated.Stan BenjamensPranavsingh DhunnooBertalan MeskóNature PortfolioarticleComputer applications to medicine. Medical informaticsR858-859.7ENnpj Digital Medicine, Vol 3, Iss 1, Pp 1-8 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	Computer applications to medicine. Medical informatics R858-859.7
spellingShingle	Computer applications to medicine. Medical informatics R858-859.7 Stan Benjamens Pranavsingh Dhunnoo Bertalan Meskó The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database
description	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 the US Food & Drugs Administration (FDA). We aimed to raise awareness of the importance of regulatory bodies, clearly stating whether a medical device is AI/ML based or not. Cross-checking and validating all approvals, we identified 64 AI/ML based, FDA approved medical devices and algorithms. Out of those, only 29 (45%) mentioned any AI/ML-related expressions in the official FDA announcement. The majority (85.9%) was approved by the FDA with a 510(k) clearance, while 8 (12.5%) received de novo pathway clearance and one (1.6%) premarket approval (PMA) clearance. Most of these technologies, notably 30 (46.9%), 16 (25.0%), and 10 (15.6%) were developed for the fields of Radiology, Cardiology and Internal Medicine/General Practice respectively. We have launched the first comprehensive and open access database of strictly AI/ML-based medical technologies that have been approved by the FDA. The database will be constantly updated.
format	article
author	Stan Benjamens Pranavsingh Dhunnoo Bertalan Meskó
author_facet	Stan Benjamens Pranavsingh Dhunnoo Bertalan Meskó
author_sort	Stan Benjamens
title	The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database
title_short	The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database
title_full	The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database
title_fullStr	The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database
title_full_unstemmed	The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database
title_sort	state of artificial intelligence-based fda-approved medical devices and algorithms: an online database
publisher	Nature Portfolio
publishDate	2020
url	https://doaj.org/article/57ebc19d581944ad8bbd6b42f5de1019
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The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database

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