AI App That Measures Vital Signs via Smartphone Camera Cleared by SFDA
The authority said it is the first regulator worldwide to authorise a digital medical app of its kind.
Marketing authorization has been granted by the Saudi Food and Drug Authority (SFDA) for an artificial intelligence-powered medical application that uses a smartphone camera to measure heart rate, oxygen saturation and blood pressure.
According to the authority, it is the first regulator worldwide to approve a digital medical application of this kind, following a review of technical documentation and clinical evidence to verify its safety and performance.
The application uses remote photoplethysmography technology, which analyses a short facial video and applies advanced algorithms to extract signals related to heart rate, oxygen saturation and blood pressure.
For blood pressure measurements, users are required to complete an initial calibration using a certified medical device.
The SFDA noted that the app is not intended to function as a standalone diagnostic tool and should not be used in emergency or critical care situations.
The authorization followed collaboration between the SFDA and the Ministry of Health, represented by Seha Virtual Hospital, with the application submitted by a specialised Canadian company.
Before receiving approval, the technology was tested within the authority's regulatory sandbox and later advanced through the Innovative Medical Devices pathway.
The evaluation process included a clinical trial conducted in the Kingdom and the completion of all regulatory requirements.
