Among the First Worldwide: SFDA Grants Marketing Authorization for Innovative Dual Glucose and Ketone Monitoring Device

The Saudi Food and Drug Authority (SFDA) has granted marketing authorization for an innovative medical device utilizing next-generation biosensor technology. The device enables continuous, real-time, and accurate monitoring of blood glucose and ketone levels around the clock, supporting improved diabetes management and accelerating clinical response times for critical cases.

Regulatory approval was facilitated through the SFDA’s Innovative Medical Devices Pathway, designed to accelerate the entry of innovative health technologies into the Saudi market while ensuring adherence to the highest standards of safety, efficacy, and quality.

Scientific Evaluation and Regulatory Leadership

The SFDA is among the first regulatory authorities globally to grant marketing authorization for this innovative medical device, which is also the first of its kind authorized for use in Saudi Arabia. The device underwent a comprehensive scientific and regulatory evaluation, including a review of technical and clinical documentation, assessment of safety and performance data, and verification of clinical trial results to ensure compliance with applicable regulatory requirements.

Advancing Clinical Outcomes and Patient Safety

This device represents a significant advancement in monitoring patients at risk of diabetic ketoacidosis (DKA)—one of the most severe acute complications of diabetes—by providing simultaneous, real-time monitoring of glucose and ketone levels. The technology enables early detection of physiological changes, supports timely clinical decision-making, and empowers both patients and healthcare providers to manage the condition proactively, contributing to improved healthcare quality and patient safety.

Driving Innovation and Vision 2030 Objectives

This milestone reflects the SFDA’s ongoing commitment to fostering an innovative-enabling regulatory environment for the medical devices sector and supporting the adoption of innovative health technologies. It directly supports the objectives of the National Biotechnology Strategy and contributes to the Health Sector Transformation Program, a key pillar of Saudi Vision 2030 aimed at elevating the quality of healthcare services and accelerating the adoption of innovative medical solutions in line with global best practices.