Saudi regulator clears AI app that measures vital signs from a smartphone camera

Saudi Arabia’s food and drug regulator has granted marketing authorization to an AI-powered medical app that measures heart rate, oxygen saturation and blood pressure from a phone camera. The decision makes SFDA the first regulator worldwide to approve the application and could broaden access to remote vital-sign monitoring under the Kingdom’s digital health push.

Why it matters: - The approval could expand access to basic vital-sign checks through a smartphone, without needing a traditional medical device at the point of care. - The decision positions the Saudi Food and Drug Authority as the first regulatory authority globally to grant marketing authorization for this application. - The authorization supports Saudi Arabia’s broader health transformation agenda during the Year of AI 2026 and under Saudi Vision 2030.

What happened: - The Saudi Food and Drug Authority granted marketing authorization for an AI-powered digital medical application that measures heart rate, oxygen saturation and blood pressure using smartphone cameras. - The decision followed a review of technical documentation and clinical evidence to assess safety and performance. - The application was submitted by a specialized Canadian company. - The approval was announced in Riyadh on June 22, 2026.

The details: - The application uses remote photoplethysmography, or rPPG, to analyze a short facial video and estimate vital signs. - The application requires an initial blood pressure calibration with a certified medical device to improve accuracy. - The application is not a standalone diagnostic tool. - The application is not intended for emergency or critical care use. - The project advanced through the Saudi Food and Drug Authority’s Regulatory Sandbox before moving to the Innovative Medical Devices pathway. - The application completed all evaluation requirements, including a dedicated clinical trial conducted in Saudi Arabia. - The development involved collaboration between the Saudi Food and Drug Authority and the Ministry of Health, represented by the Seha Virtual Hospital.

Between the lines: - The authorization signals a more structured path for digital health tools in Saudi Arabia, where regulators are pairing innovation with clinical validation. - The clinical-trial requirement in Saudi Arabia suggests the authority wanted local evidence before allowing market access. - The use of a sandbox and a dedicated approval pathway points to a regulatory model designed to test emerging technologies before wider rollout.

What's next: - The approval may encourage more digital health developers to seek Saudi market access through the same regulatory channels. - The SFDA’s decision could serve as a reference point for future reviews of AI-enabled medical devices in the region. - Broader use of the app will likely depend on how providers and patients adopt the tool within approved use cases.

The bottom line: - Saudi Arabia has opened the door to a new class of AI-enabled medical apps, but the approval is tightly framed around safety, calibration and non-emergency use.