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.
Founded in Berlin, Germany, in 2015, DiaMonTech is a medical technology company committed to improving health outcomes for people with diabetes and empowering them to take control of their lifelong health. Its pioneered and patented non-invasive “no prick” photothermal detection technology is fast and painless and doesn’t require needles or test strips. An industry first, DiaMonTech monitors the actual glucose molecules in skin, providing users with a more comprehensive and accurate reading comparable to invasive commercial devices. DiaMonTech achieved 99.1% accuracy in a test study with 100 people studied, received the CE mark as a medical device in April 2019 and is currently under FDA review. To support its mission, DiaMonTech is led by a world-class team of scientists, researchers and healthcare experts.
More information about DiaMonTech can be found at www.diamontech.de.