FDA-cleared artificial intelligence and machine learning-based medical devices and their 510(k) predicate networks
Summary: 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 a former cleared device (ie, predicate)....
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2023-09-01
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| Series: | The Lancet: Digital Health |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589750023001267 |