The test Neo-Bilirubin was CE-marked on 21 April 2020 after satisfactory results were obtained in the research study carried out at Södersjukhuset. However, the study had to be closed prematurely due to reprioritisations of resources at Södersjukhuset as a result of the covid-19 pandemic, which meant that the study could not proceed as planned. As announced in April 2021, the situation was still the same.
"We are very happy to get started again with our collaboration with Sachsska Children's Hospital", says Anna Söderlund, CEO of Calmark. "The product is already CE-marked, but we still think it is worthwhile to conduct a new study with the customer to verify product improvements and get updated data.".
Every care has been taken in the translation of this document. In the event of discrepancies, the Swedish original will supersede the English translation.