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Med."],"abstract":"<jats:title>Abstract<\/jats:title><jats:p>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 &amp; 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.<\/jats:p>","DOI":"10.1038\/s41746-020-00324-0","type":"journal-article","created":{"date-parts":[[2020,9,11]],"date-time":"2020-09-11T10:09:21Z","timestamp":1599818961000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":951,"title":["The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database"],"prefix":"10.1038","volume":"3","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3266-9246","authenticated-orcid":false,"given":"Stan","family":"Benjamens","sequence":"first","affiliation":[]},{"given":"Pranavsingh","family":"Dhunnoo","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7005-7083","authenticated-orcid":false,"given":"Bertalan","family":"Mesk\u00f3","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2020,9,11]]},"reference":[{"key":"324_CR1","doi-asserted-by":"publisher","first-page":"509","DOI":"10.1001\/jama.2019.21579","volume":"323","author":"ME Matheny","year":"2020","unstructured":"Matheny, M. 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