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Siemens Healthineers Gets CE Mark for Point-of-Care High-Sensitivity Cardiac Troponin I Test

NEW YORK — Siemens Healthineers said on Monday that it has received the CE mark for its point-of-care Atellica VTLi Patient-Side Immunoassay Analyzer, a test for high-sensitivity cardiac troponin I (hs-cTnI).

According to the Erlangen, Germany-based company, the handheld test detects hs-cTnI — a protein biomarker of acute myocardial infarction — in fingerstick blood samples within eight minutes.

The technology underlying the test was developed by Dutch firm Minicare, which was acquired by Siemens in 2019.

"We are … the first company to offer a true point-of-care high-sensitivity cardiac troponin I test with results comparable to laboratory performance using just a fingerstick sample," Christoph Pedain, head of point-of-care diagnostics at Siemens, said in a statement. "Healthcare providers have been waiting decades for hs-cTnI at the point of care and now the wait is over."