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BriefMEDTECH

Nanosensor Real-Time Blood Glucose Monitoring System GlucoNano Receives FDA Approval: Single Implant Lasts 90 Days

Israeli company GlucoNano's subcutaneously implanted nanosensor received FDA approval, using graphene quantum dots for continuous 90-day real-time blood glucose monitoring with accuracy matching venous blood draws, requiring no fingerstick calibration.

Israeli nanomedicine company GlucoNano announced on April 3 that its subcutaneously implanted nano blood glucose sensor received FDA approval. The sensor, grain-of-rice sized (3mm x 1mm), is implanted in the upper arm subcutaneously via minimally invasive injection, using graphene quantum dot fluorescence properties to continuously detect glucose concentration in interstitial fluid, transmitting data via Bluetooth to a smartphone app. The sensor's designed operational life is 90 days, with simple outpatient replacement upon expiration.

In the pivotal clinical trial, GlucoNano achieved a Mean Absolute Relative Difference (MARD) of 7.2%, approaching the gold standard of venous blood draws and outperforming current market-leading continuous glucose monitoring (CGM) products (which typically have MARDs of 9-12%). The greatest advantage is requiring no fingerstick calibration — traditional CGM products typically need at least one daily fingerstick for sensor calibration, while GlucoNano requires zero calibration throughout its entire usage period.

GucoNano plans to price each sensor at $299 in the US market (90-day supply), lower than current mainstream CGM products' monthly costs. The company has completed $150 million in funding and plans to enter European and Asian markets by the end of 2028.