Many AI-enabled medtech products leverage machine learning or deep learning. In order to address the opaque decision-making processes, explainability is essential to enhance trust, safety, and ...
Image credit: Ross Law For healthcare firms involved in the spaces of software-as-a-medical-device (SaMD), or digital devices and artificial intelligence (AI) devices, compliance with the European ...
with almost 1,000 AI-enabled medical devices approved as of 2024, ranging from predictive glucose monitors to smartwatches capable of predicting atrial fibrillations. They also pose genuine harm ...