SFDA Rejects AI-Powered Diabetes Prediction Device for Failing Safety and Efficacy Standards
2025-07-02
The Saudi Food and Drug Authority (SFDA) has rejected a marketing authorization application in the Kingdom of Saudi Arabia for a software medical device designed to predict the likelihood of developing Type 2 diabetes within the next four years in adults over 18. This AI and machine learning-powered device, despite being marketed in some European countries, failed to meet the Kingdom's safety and efficacy requirements.