ISO 13485:2016 certification

September 14, 2023

We are excited to share that SpinChip Diagnostics has successfully obtained ISO 13485:2016 certification for our Quality Management System. In the Medical Device Industry, safety and quality are non-negotiables. At SpinChip, we strive to meet the highest standards across our QMS. This certification demonstrates our commitment to developing a safe, high-quality point-of-care platform that delivers highly…

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PRESS RELEASE – SpinChip Diagnostics’ Point-of-Care platform demonstrates diagnostic performance on par with state-of-the-art clinically validated laboratory analyzers

June 8, 2023

Oslo, (8 June 2023) — SpinChip Diagnostics AS (SpinChip), a pioneering diagnostics company developing a next-generation point-of-care (POC) platform for in vitro diagnostics, today announced positive results from a diagnostic study using biobank samples from the prospective international APACE (Advantageous Predictors of Acute Coronary Syndrome Evaluation) study.   The study aimed to evaluate the diagnostic accuracy…

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PRESS RELEASE – SpinChip Secures NOK 65.4 million in Financing Round

April 26, 2023

The financing round finances the design verification and sample comparison study as well as a retrospective study with 3,600 frozen patient samples. The proceeds will also finance further development of new assays as well as the start of clinical trials, ISO 13485 certification and other operating expenses. Oslo, Norway, 25 April 2023 — SpinChip Diagnostics…

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Welcome Glenn Gundersen

November 16, 2022

We are excited to welcome Glenn Gundersen to the SpinChip team as our new Head of Clinical and Medical Affairs. He will be responsible for leading our clinical programs for the validation of our Point of Care biomarker assays. Glenn brings more than 25 years of experience from the MedTech and pharmaceutical industry, ranging from small and…

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