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Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting
3
Zitationen
6
Autoren
2025
Jahr
Abstract
: While 2024 marked a record year for ML-enabled device approvals and internationalization, uptake of PCCPs and transparent performance and demographic reporting remained limited. Policy efforts to standardize disclosures and strengthen post market oversight are critical for realizing the promises of GMLP.
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