DiagnOptics receives CE mark approval for Diab-spot.
December 21, 2011
DiagnOptics receives CE mark approval for their latest product, Diab-spot. Diab spot is a non-invasive test to identify people at risk for diabetes or pre-diabetes . The CE mark allows DiagnOptics to market Diab-spot in the European Union.
DiagnOptics was the first company worldwide to introduce a technology to noninvasively measure the tissue accumulation of AGEs by means of fluorescence techniques (AGE Reader). Diab-spot features this AGE measurement and combines this with a small number of patient characteristics to calculate the Diab-spot test result. These simple characteristics include questions about other well-known diabetes risk factors , which can be easily answered on the touch screen. Diab-spot yields an immediate screening result on the spot.
The detection of (pre-)diabetes patients by Diab-spot is superior to the two most common diabetes screening tests, FPG (Fasting Plasma Glucose) and HbA1c (glycated hemoglobin). In a multi-center clinical study in the Netherlands, both sensitivity and specificity of Diab-spot were significantly better than FPG and at least as good as HbA1c.
Meest actuele nieuwsberichten
- DiagnOptics and PATH partner on project on diabetes screening in India 2012
- DiagnOptics receives CE mark approval for Diab-spot. 2011
- DiagnOptics receives Health Canada approval for the AGE Reader. 2011
- New product for diabetes detection, Diab-spot, introduced in Madrid. 2011
- DiagnOptics receives ISO 13485 certification. 2010
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