The Saudi Food and Drug Authority (SFDA) has granted marketing authorization for an artificial intelligence-powered digital medical application that measures heart rate, blood oxygen saturation, and blood pressure using a smartphone camera.
The approval makes the SFDA the first regulatory authority in the world to authorize the application.
The authorization followed a comprehensive evaluation of the application’s technical documentation and clinical evidence to verify its safety and performance before its introduction to the Saudi market.
The application uses remote photoplethysmography (rPPG) technology, which combines advanced algorithms with facial video captured through a smartphone camera to measure vital signs.
According to the SFDA, users are required to complete an initial blood pressure calibration using a certified medical device to ensure measurement accuracy.
The authority said the application is not intended to function as a standalone diagnostic tool and should not be used for emergency or critical care situations.
The application was developed by a specialized Canadian company and was evaluated through the SFDA’s Regulatory Sandbox before progressing to the authority’s Innovative Medical Devices pathway.
The evaluation process included a review of technical documentation, clinical evidence, and a dedicated clinical trial conducted in Saudi Arabia to assess the application’s safety and performance.
The project was carried out in collaboration with the Ministry of Health, represented by Seha Virtual Hospital.
Supporting digital health innovation
The SFDA stated that the approval reflects its efforts to facilitate the introduction of digital health technologies while ensuring they meet regulatory requirements for safety and effectiveness.
The authority added that the authorization supports innovation in the healthcare sector by providing a regulatory pathway for advanced medical technologies.
The approval also aligns with activities under the Year of Artificial Intelligence 2026 and supports the Health Sector Transformation Program, one of the key initiatives under Saudi Vision 2030 aimed at advancing healthcare services and digital innovation in the Kingdom.
