Noninvasive Blood Glucose Monitoring Receives FDA Breakthrough Device Designation: Apple, Samsung Race Ahead
A noninvasive blood glucose monitoring device based on spectral analysis receives FDA Breakthrough Device Designation, as tech giants accelerate health monitoring wearable development.
Noninvasive blood glucose monitoring technology has finally achieved a major breakthrough. SenseGlucose announced this week that its near-infrared spectroscopy-based noninvasive blood glucose monitoring device received FDA Breakthrough Device Designation, with market entry expected within 18 months. The news has triggered a race among tech giants.
Technical Principles
The SenseGlucose device emits near-infrared light through the skin, measures glucose molecules' absorption of specific wavelength light, and uses AI algorithms to estimate blood glucose concentration in real time. Users simply wear a smartwatch-like device for continuous glucose monitoring without finger pricks.
Clinical trial data shows the device's Mean Absolute Relative Difference (MARD) is 9.2%, meeting the International Diabetes Federation's diagnostic-grade accuracy standard.
Tech Giants Follow Suit
Apple revealed in its latest earnings report that Apple Watch's noninvasive blood glucose monitoring feature has entered clinical validation, expected to launch in 2028. Samsung announced the acquisition of two noninvasive sensor startups, with Galaxy Watch's noninvasive blood glucose feature expected next year.
Market Impact
With approximately 550 million diabetes patients globally, traditional blood glucose monitoring requires frequent finger pricks, causing pain and economic burden. Analysts predict the noninvasive blood glucose monitoring device market will exceed $20 billion by 2030.
Disclaimer
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