2 results
Approved WMOCompleted
The objective of this study is the determination of the diagnostic quality (sensitivity, specificity, positive predictive value, negative predictive value) for the detection of malignant or pre-malignant tumor with the DELSENI in comparison with…
Approved WMOPending
The primary objective is to obtain post-market clinical data according to the requirements of the MEDDEV 2.21/2 in order to fulfil 18 post-market surveillance (PMS) obligations according to Section 3.1 of Annex II, 19 Section 3 of Annex IV, Section…