Saudi Arabia has taken a significant step in digital healthcare innovation as the Saudi Food and Drug Authority (SFDA) has granted marketing authorization for an AI-powered medical application that can measure vital signs using a smartphone camera.

The approved application is capable of tracking heart rate, blood oxygen saturation, and blood pressure through advanced facial video analysis, marking a notable advancement in mobile health technology in Saudi Arabia.

According to the SFDA, this is the first time a regulatory authority globally has granted marketing authorization for this specific type of application. The approval followed a comprehensive scientific review process that assessed technical documentation and clinical evidence to ensure both safety and performance standards were met.

The app uses remote photoplethysmography (rPPG) technology, which applies advanced algorithms to analyze subtle changes in facial skin color captured through short video recordings. To ensure accuracy, users must first complete a blood pressure calibration using a certified medical device. The app is not intended to function as a standalone diagnostic tool and is not suitable for emergency or critical care situations.

The project was developed through collaboration between the SFDA and the Ministry of Health, represented by the Seha Virtual Hospital. Developed by a Canadian company, the application underwent rigorous evaluation within the SFDA’s Regulatory Sandbox before advancing to the Innovative Medical Devices pathway, including a clinical trial conducted in Saudi Arabia.

The SFDA said the approval reflects its commitment to supporting digital health innovation while ensuring safe and regulated adoption of advanced technologies. It also aligns with national efforts to accelerate healthcare transformation and promote medical innovation during the Year of Artificial Intelligence 2026.

The milestone further strengthens the SFDA’s role in integrating advanced technologies into the healthcare system under the Health Sector Transformation Program, a key component of Saudi Vision 2030.

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