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BioWorld - Friday, July 18, 2025
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Home » FDA clears new biomarker test from Astute Medical for acute kidney injury
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FDA clears new biomarker test from Astute Medical for acute kidney injury

Sep. 10, 2014
By Amanda Pedersen
A new test used to assess risk for acute kidney injury (AKI) could help doctors significantly improve management of ICU patients and reduce costs to the healthcare system. Astute Medical (San Diego) said it has received FDA 510(k) clearance for its first biomarker-based immunoassay, the NephroCheck test system, designed to assess risk for AKI. Astute has designated Ortho-Clinical Diagnostics (Raritan, New Jersey) as the exclusive sales agent for the NephroCheck test.
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