{
  "id": 2189342,
  "title": "SFDA grants marketing authorization for innovative dual glucose and ketone monitoring device",
  "url": "https://urgent.news/2026/08/20/sfda-grants-marketing-authorization-for-innovative-dual-glucose-and",
  "topic": "world",
  "section": "World",
  "published": "2026-08-20T16:35:54.000Z",
  "source": {
    "name": "Saudi Gazette",
    "slug": "saudi-gazette",
    "url": "https://saudigazette.com.sa/article/663911/saudi-arabia/sfda-grants-marketing-authorization-for-innovative-dual-glucose-and-ketone-monitoring-device"
  },
  "original_language": "en",
  "account": "Riyadh - The Saudi Food and Drug Authority (SFDA) has granted marketing authorization for a groundbreaking medical device that combines glucose and ketone monitoring capabilities. This innovative technology uses next-generation biosensor technology to provide continuous, real-time, and accurate measurement of blood glucose and ketone levels, enabling improved diabetes management and faster clinical responses.\n\nThe SFDA's approval was achieved through its Innovative Medical Devices pathway, a program aimed at swiftly bringing advanced health technologies to the Saudi market while maintaining stringent safety, efficacy, and quality standards. This device is the first of its kind to receive regulatory clearance in Saudi Arabia, marking a significant global milestone.\n\nThe device underwent rigorous scientific and regulatory scrutiny, involving a thorough review of technical and clinical documentation, safety and performance assessments, and verification of clinical trial results. By offering simultaneous, real-time monitoring of glucose and ketone levels, the device can detect early signs of diabetic ketoacidosis (DKA), a critical complication of diabetes, allowing for timely medical intervention and proactive patient management.\n\nThis achievement underscores the SFDA's dedication to fostering an innovation-friendly regulatory landscape for medical devices and promoting the use of cutting-edge health technologies. The approval aligns with the goals of the National Biotechnology Strategy and the Health Sector Transformation Program, key components of Saudi Vision 2030, which aim to enhance healthcare quality and expedite the integration of innovative medical solutions in the country.",
  "summary": "RIYADH —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…",
  "key_points": [],
  "editors_take": null,
  "illustration": null,
  "coverage": {
    "outlets": 1,
    "also_reported_by": []
  },
  "ai_generated": true,
  "disclaimer": "Summaries, key points and the editor’s take are written by software from other outlets’ reporting and may contain errors — always check the linked original."
}