Calmark Sweden AB

Calmark Sweden AB
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Calmark is a medical technology company that manufactures 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, is CE marked and measures the bilirubin level in whole blood for jaundice detection in newborns. 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 offers 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. 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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In every aspect, this was an amazing journey, Getting such broad feedback from end users was invaluable, both for us and our distributor.

Magdalena Tharaldsen, Director International Business Development.

I very much look forward to being involved in the management and development of Calmark, a company with thrilling times ahead

Madeleine Skoglund, CFO

Calmark's products are suitable for all markets worldwide. However, we choose to prioritize the markets where we already have good collaborations and see that launch and sales can take place in the near future.

Anna Söderlund, CEO Calmark

Getting such positive feedback directly from end users in hospitals has been priceless, everyone truly appreciates the value of the product.

Magdalena Tharaldsen, Calmark’s Director International Business Development

The products will be delivered to end customers in the Northern regions, according to the roll-out plan.

Magdalena Tharaldsen, Director International Business Development at Calmark

We have worked really hard to develop a product that is feasible worldwide. Both in highly developed healthcare systems and in low-income countries. 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!

Anna Söderlund, CEO

It is with deep satisfaction that we announce the CE conformity marking of our product COVID19-LDH

Anna Söderlund, CEO

It is truly inspiring and heartening to join the Calmark team and be able to make use of my experience in a new context

Magdalena Tharaldsen, Director of International Business Development

We are very pleased with the collaboration with Triolab and it feels great that we can now reach more markets together.

Marianne Alksnis, International Sales Director of Calmark

It is with heartfelt satisfaction that we announce the CE conformity marking of our first product

Anna Söderlund, CEO

I am very proud to have been proposed to chair the Board of Directors of Calmark Sweden AB in this pivotal stage of the Company's development. I see tremendous potential in the company and its products; POC diagnostics is a rapidly growing area and Calmark's offering is strong. It is also good to know that Mathias will remain on the board so that he can continue to share his knowledge.

Kjersti Berg Marthinsen

We have held meetings with more than 50 actors and been given unique opportunities to demonstrate our platform and discuss partnerships around sales.

Marianne Alksnis, International Sales Director

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Calmark's LDH test for assessment of COVID-19 enters the verification and validation phase of the CE marking process – analytical results are within the expected range

Thu, Feb 18, 2021 16:31 CET

Calmark Sweden AB (publ) announces today that the development project for the Company's product COVID19-LDH now moves to verification and validation. This phase is one of last steps in the process, with an estimated duration of approximately five weeks. Thereafter, the product will move into production, and CE mark certification can take place.CE conformity marking and the development of medical devices follows a seven-step process, where the first three steps involve requirements capture and development. The product is then verified against the prescribed requirements and validated by

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Calmark's LDH test for assessment of COVID-19 enters the verification and validation phase of the CE marking process – analytical results are within the expected range

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Calmark's LDH test for assessment of COVID-19 enters the verification and validation phase of the CE marking process – analytical results are within the expected range

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