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

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Know Labs seeks approval for first non-invasive glucose monitor.

Know Labs, a technology company based in Washington, has recently submitted an application to the US Food and Drug Administration (FDA) seeking approval for its non-invasive glucose monitor. If approved, this device would be the first of its kind to allow people with diabetes to monitor their blood sugar levels without the need for painful finger pricks.

Diabetes is a chronic condition that affects millions of people worldwide. It occurs when the body is unable to produce or properly use insulin, a hormone that regulates blood sugar levels. People with diabetes must monitor their blood sugar levels regularly to avoid complications such as nerve damage, kidney disease, and blindness. Traditionally, this has been done through finger pricks, which can be painful and inconvenient.

Know Labs’ non-invasive glucose monitor uses a technology called Bio-RFID, which stands for biological radio frequency identification. This technology uses radio waves to detect glucose levels in the body without the need for a blood sample. The device is worn on the wrist like a watch and sends data to a smartphone app, allowing users to track their glucose levels in real-time.

The Bio-RFID technology works by emitting radio waves that interact with the glucose molecules in the body. These interactions create a unique signal that can be detected by the device and translated into a glucose reading. The device is also able to distinguish between glucose and other molecules in the body, ensuring accurate readings.

Know Labs’ non-invasive glucose monitor has the potential to revolutionize diabetes management by making it easier and less painful for people to monitor their blood sugar levels. It could also improve compliance with monitoring regimens, as people may be more likely to use a non-invasive device than one that requires finger pricks.

However, before the device can be made available to the public, it must first receive FDA approval. This process can take several months or even years, as the FDA must ensure that the device is safe and effective for its intended use. Know Labs is currently awaiting a response from the FDA regarding its application.

In conclusion, Know Labs’ non-invasive glucose monitor has the potential to be a game-changer for people with diabetes. By eliminating the need for painful finger pricks, it could make diabetes management easier and more convenient. However, it remains to be seen whether the device will receive FDA approval and become available to the public.

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