Making a clinical diagnosis without a definitive blood draw or tissue sample sounds like science fiction but current trends in AI/ML (artificial intelligence and machine learning)and their utilization in In Vitro Diagnostics are changing the interface of science and bedside medicine. Modern medical devices incorporate image recognition, robotics, deep learning algorithms and gesture recognition classifying them as “smart diagnostics”. In vitro diagnostic laboratory results pad data for software systems used in pattern recognition modeling but also are open to review by a myriad of stakeholders. To obtain a CE mark for a smart IVD device, medical device manufacturers must meet both performance and ethical use standards as outlined by In Vitro Diagnostic Devices Regulation (EU) 2017/746.
This article takes a closer look at the use of AI and ML in complying with the new IVDR requirements. You can access the article here.
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