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Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation
0
Zitationen
5
Autoren
2025
Jahr
Abstract
As the level of patient risk under the current regulatory pathways remains uncertain, future research should compare AI/ML-enabled device recall rates across jurisdictions to assess whether AI-specific regulatory frameworks improve patient safety and device reliability.
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