SFDA grants marketing authorization for AI-powered medical app
- The Saudi Food and Drug Authority granted marketing authorization for a digital medical application that measures heart rate, oxygen saturation and blood pressure using smartphone cameras.
- The SFDA is the first regulatory authority globally to grant marketing authorization for this application.
- Approval followed a comprehensive evaluation of technical documentation and clinical evidence; the app uses remote photoplethysmography on a short facial video, requires initial blood pressure calibration with a certified medical device, and is not a standalone diagnostic tool or intended for emergency/critical care use.
- The app’s launch resulted from collaboration between the SFDA and the Ministry of Health (represented by Seha Virtual Hospital); it was tested in the SFDA’s Regulatory Sandbox, moved through the Innovative Medical Devices pathway, and completed a clinical trial in Saudi Arabia.
Arab News · 2026-06-22