RIYADH — The Saudi Food and Drug Authority (SFDA) has granted marketing authorization for an innovative medical device that uses next-generation biosensor technology to continuously monitor blood glucose and ketone levels in real time.

The device is designed to provide accurate, around-the-clock monitoring of both glucose and ketones, supporting better diabetes management and helping healthcare professionals respond more quickly to critical changes in a patient’s condition.

The approval was granted through the SFDA’s Innovative Medical Devices pathway, which is designed to facilitate the introduction of innovative medical technologies into the Saudi market while maintaining high standards of safety, effectiveness, and quality. The SFDA is among the first regulatory authorities worldwide to authorize the device, which is also the first of its kind approved for use in Saudi Arabia.

Before receiving authorization, the device underwent a comprehensive scientific and regulatory assessment. The evaluation included a review of technical and clinical documentation, safety and performance data, and clinical trial results to ensure that the device met applicable regulatory requirements.

The technology is particularly significant for monitoring patients at risk of diabetic ketoacidosis (DKA), a serious acute complication of diabetes. By simultaneously tracking glucose and ketone levels in real time, the device can help detect physiological changes at an early stage and support timely clinical decisions.

The SFDA said the technology can also help patients and healthcare providers manage potential complications more proactively, contributing to improved healthcare quality and patient safety.

The authorization reflects the SFDA’s continued efforts to create an environment that supports innovation in the medical devices sector and encourages the adoption of advanced healthcare technologies. The initiative also supports the objectives of Saudi Arabia’s National Biotechnology Strategy and the Health Sector Transformation Program, a key component of Saudi Vision 2030.

Source:Saudi Gazette