Press Release

Berlin, 9 September 2020

With the submission of the pre-submissionapplication to the US Food and Drug Administration (FDA), the company has initiated the approval process of its product D-Base as a medical device in the US.

D-Base uses the innovative DiaMonTech technology for non-invasive, precise,and painless measurement of blood glucose levels and it is optimized for use in professional environments such as diabetes centers.

For diabetes patients and prediabetics, DiaMonTech is developing the smaller D-Pocket, which builds on the same laser technology.

In the next step of the approval process, DiaMonTech will align with the FDA on the regulatory approval path for the US.

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Project: non-invasive blood glucose monitor "DMT-Pocket". The goal of the project is the implementation of the scientific method of photothermal spectroscopy into a mobile medical product for non-invasive blood glucose measurement for the end customer. The focus is on measurement accuracy, miniaturization and the successful certification of the device. The measuring device to be developed (DMT Pocket) has the shape and size of a common smartphone. The measurement for the end customer is fast, very easy to perform and without further interference. The end customer places a finger on the sensor field, waits about 10-15 seconds and the device shows the blood glucose value directly on the display. The actual measuring process is absolutely painless and without any risk.The procedure will be very similar to unlocking a mobile phone with a fingerprint sensor.

DiaMonTech submits to FDA pre-submission application for non-invasive blood glucose meter D-Base

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