The article discusses the increasing prevalence of artificial intelligence-based diagnostic tests and the challenges faced in regulating these devices while maintaining a balance between innovation and patient safety. Regulators in the US and Europe are grappling with how to evaluate in vitro diagnostic tests with updating algorithms, emphasizing the need for developers to ensure product safety and prevent algorithm drift.
AI-based tools are being used for various applications such as identifying aberrant cells, biomarker combinations linked to diseases, and analyzing patient-specific risk factors. Companies like Siemens Healthineers, Hologic, and Prenosis are leveraging AI in their diagnostic solutions to improve efficiency and accuracy in areas like cancer screening and sepsis diagnosis. The FDA has approved numerous AI/ML-based medical devices, with a significant focus on radiology applications.
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