Calmark’s product Neo-Bilirubin will obtain CE Mark approval in January 2020

Calmark’s product Neo-Bilirubin will obtain CE Mark approval in January 2020

Pressmeddelanden
Press releases
Calmark’s product for the bilirubin biomarker will obtain its CE conformity marking after the turn of the year. A partial study of the verification and validation process still remains, and the study at Södersjukhuset is not finished.

The majority of verification and validation testing, which is the final stage of the CE conformity marking process, has now been successfully performed. A couple of days of laboratory testing remain, however, and some of the planned children have not yet been included in the Södersjukhuset study.

We are very happy about the results so far. It is unfortunate that we did not manage to complete the entire process for the CE Mark approval before the turn of the year, but this will not affect the market launch of the products,” says Anna Söderlund, CEO.

This information is information that Calmark Sweden AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on 23 December 2019, 16:30 CET.

Every care has been taken in the translation of this document. In the event of discrepancies, the Swedish original will supersede the English translation.