FDA clearance and CE marking are both essential for market access and regulatory compliance of AI radiology tools. These evaluations confirm that a device is safe, performs as intended, and complies with required quality standards. Yet, in practice, these approvals tell only half the story. That’s because they don’t guarantee that the AI tool will fit into your workflow, be used by your radiologists, and give you a good ROI. So the real question is no longer “Is it cleared?” but “Does it work in my practice, for my patients, with my team?” In this blog, we’ll cover what these approvals mean and five things to consider when evaluating FDA or CE-marked AI tools. We’ll also highlight how tools within the Rayvolve® AI Suite meet these expectations while also making sure they perform well in real-world settings.
