Navigating regulatory and policy challenges for AI enabled combination devices
In recent years, the Artificial Intelligence (AI) has enabled conventional Combination Devices (CDs) to innovate in healthcare merging with technology sectors. However, the challenges like reliance on predicate devices in US Food and Drug Administration (FDA's 510(k) pathway, especially for per...
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| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2024-11-01
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| Series: | Frontiers in Medical Technology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fmedt.2024.1473350/full |
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