A Comprehensive Guide to Clinical Investigations: Content and Modifications in the EU – MDCG Guidance

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Know Labs is seeking approval for the first non-invasive glucose monitor.

Know Labs, a technology company based in Seattle, is seeking approval from the U.S. Food and Drug Administration (FDA) for the first non-invasive glucose monitor. This device, called the Bio-RFID™ glucose monitoring system, uses radio frequency identification (RFID) technology to measure glucose levels without the need for a blood sample.

Currently, people with diabetes must prick their fingers multiple times a day to check their blood sugar levels. This process can be painful, inconvenient, and can lead to infections or other complications. The Bio-RFID™ glucose monitoring system aims to eliminate these issues by providing a non-invasive alternative.

The device works by using a small sensor that is placed on the skin. The sensor emits radio waves that penetrate the skin and interact with glucose molecules in the interstitial fluid (the fluid that surrounds cells). The device then measures the changes in the radio waves caused by the glucose molecules and calculates the glucose level in the blood.

The Bio-RFID™ glucose monitoring system has been in development for several years and has undergone multiple clinical trials. In a recent study, the device was found to be accurate within 10% of laboratory reference values 95% of the time. This level of accuracy is comparable to traditional blood glucose monitors.

If approved by the FDA, the Bio-RFID™ glucose monitoring system could revolutionize diabetes management. It would provide a painless and convenient way for people with diabetes to monitor their glucose levels, leading to better control of their condition and potentially reducing the risk of complications.

In addition to diabetes management, the Bio-RFID™ technology has potential applications in other areas of healthcare. For example, it could be used to monitor other biomarkers in the body, such as cholesterol or electrolytes.

Know Labs is currently working with the FDA to gain approval for the Bio-RFID™ glucose monitoring system. If approved, the device could be available to consumers within the next few years. This would be a significant step forward in the field of non-invasive glucose monitoring and could improve the lives of millions of people with diabetes.

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