Glucose– tag –
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Biolinq’s Needle-Free Autonomous Wearable Biosensor, Shine™, Receives FDA De Novo Classification, Establishing New Device Category
EvoNexus USA Overview Biolinq, an EvoNexus graduate company, announced that its Shine™ device, a needle-free autonomous wearable biosensor, has received FDA De Novo classification. This classification creates a new regulatory category fo... -
Eindhoven University of Technology’s GlucoPilot Project Develops AI-Powered Personal Glucose Coach with Smart Ring and Lifestyle Data Integration
Eindhoven University of Technology Netherlands Overview The 'GlucoPilot' project, involving researchers from Eindhoven University of Technology, is developing an AI-powered personal glucose coach. This system integrates continuous glucos... -
UC San Diego Researchers Develop ‘CHARM Ring’ for Non-Invasive Glucose and Lactate Monitoring
AboutRun USA Overview Researchers at the University of California San Diego have developed a prototype 'CHARM Ring' that non-invasively monitors up to four biomarkers, including glucose and lactate, using passive fluid extraction from th... -
FDA Clears Dexcom’s Stelo OTC Continuous Glucose Monitor for Non-Insulin Users Aged Two and Up
Prime Therapeutics - Portal USA Overview The FDA has granted over-the-counter (OTC) marketing authorization for Dexcom's Stelo Glucose Biosensor System, expanding its use to non-insulin users aged two and older. This marks the first OTC ... -
Next-Generation Electrochemical Biosensors Transform Clinical Diagnostics: Driving POCT and Personalized Medicine through Portability and AI Integration
Taylor & Francis Online Unknown Overview Advances in electrochemical biosensing are revolutionizing clinical and biochemical diagnostics, enabling rapid and highly sensitive detection of biomarkers for infectious diseases, metabolic diso... -
FDA Selects Dexcom as Inaugural Participant in Digital Health Pilot to Accelerate AI-Integrated Glucose Management
Healthcare Dive USA Overview The U.S. FDA has named Dexcom as the first participant in its new digital health pilot program, designed to streamline regulatory pathways for innovative devices. This initiative will exempt certain Dexcom di... -
UC San Diego Unveils World’s First Fully Integrated Smart Ring for Simultaneous, Continuous Sweat-Based Tracking of Multiple Biomarkers Including Glucose, Ketones, and Vitamin C
UC San Diego Today USA Overview Engineers at UC San Diego have unveiled the world's first fully integrated smart ring capable of simultaneously and continuously tracking multiple biomarkers from sweat, including glucose, ketones, vitamin... -
Trinity Biotech and Latch Medical Forge Alliance for AI-Powered Precision Intradermal Drug Delivery in Metabolic Disorders
GlobeNewswire (via Trinity Biotech plc) Ireland Overview Trinity Biotech has announced a strategic partnership with Latch Medical, integrating Trinity's AI-native CGM+ wearable biosensor platform with Latch Medical's innovative intraderm... -
Dexcom Selected as First Participant in FDA’s TEMPO Pilot Program to Advance AI-Powered Glucose Health for Early Prediabetes & T2D Intervention
Business Wire (via Dexcom Investor Relations) USA Overview Dexcom has been selected as the inaugural participant in the FDA's TEMPO (Technology-Enabled Meaningful Patient Outcomes) digital health devices pilot program, aiming to accelera... -
FDA Selects Dexcom as First Participant in ‘TEMPO’ Digital Health Pilot Program
MedTech Dive USA Overview The FDA has selected Dexcom as the first participant in its new Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot Program. This pilot will enable Dexcom to implement an AI-enabled glucose health progr...
