Calmark Neo-Bilirubin receives UNICEF’s quality seal "NEST360 Qualified"
Calmark Sweden AB announced today that the company's diagnostics for jaundice, Neo-Bilirubin, meets the characteristics for products in low-income countries, developed by the organization NEST360 in collaboration with UNICEF. The award shows that Calmark's product is efficient, affordable, robust and easy to use.
Newborn Essential Solutions and Technologies (NEST360) is an international alliance of clinical, technical, and public health experts from 16 leading institutions, governments, and organizations. NEST360s is financed through support from e.g. Bill & Melinda Gates Foundation, CIFF, ELMA and MacArthur Foundation and the goal is to reduce infant mortality in African hospitals by 50%. The Alliance collaborates with the African governments to strengthen health systems with innovative technology, education, and policy resources.
NEST360 publishes i.a. the report “Newborn Technology Landscape” which contains a compilation of healthcare technologies suitable for low-income countries. The seventh edition was published on June 15, where Calmark Neo-Bilirubin receives the quality stamp "NEST360 Qualified".
To evaluate MedTech products for newborn care in low-resource settings, a five-step process with rigorous performance and usability testing is conducted. Only devices that are available for purchase and have regulatory approval are evaluated. The products that receive the quality seal "NEST360 Qualified" meet pre-defined performance metrics based on the Target Product Profiles developed in collaboration with UNICEF.
The 20 characteristics developed for bilirubinometers include e.g. Linear Range, Accuracy, Results Formats, Result Units, Precision, Sample, Calibration, Equipment Required, Stability & Storage, Pricing. The evaluation of Calmark Neo-Bilirubin has been performed by the Rice360 Institute for Global Health Technologies.
“We have worked really hard to develop a product that is feasible worldwide. Both in highly developed healthcare systems and in low-income countries ", says Anna Söderlund, CEO of Calmark. "The fact that we are now getting noticed and receive the quality seal "NEST360 Qualified" is a big and important milestone for us and a proof that we have succeeded!"
Every care has been taken in the translation of this document. In the event of discrepancies, the Swedish original will supersede the English translation.
For more information about Calmark Sweden AB, please contact:
Anna Söderlund, CEO
Telefon: +46 70 214 98 93
E-post: anna.soderlund@calmark.se
www.calmark.se
Calmark Sweden AB is a medical technology company that develops and markets a point-of-care (POC) analysis method with easier and faster diagnostics of medical conditions in newborns. The unique test platform consists of a portable instrument and test cassettes for various biomarkers. The first test, Neo-Bilirubin, was launched to the market in 2020. In the Western world, the introduction of POC diagnostics is resulting in huge savings and shorter care chains. In less developed healthcare systems, the product will offer a decision support which is currently lacking, since the access to hospital laboratories often is limited. Calmark aims to become the global leader in POC diagnostics for newborns and, in the long term, to offer all relevant tests for the first period of life. In addition to products for newborns, Calmark sells a POC test for assessment of COVID-19 disease severity. The B share is listed on the Spotlight Stock Market and is traded under the CALMA B ticker. Read more at www.calmark.se/eng/home.
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