Digital Health: QA, RA & CA Forum

Its not a diagnostic if it only categories the risks......could this be a new category? On Thursday, the FDA granted marketing authorization of Renalytix AI, Inc.’s KidneyIntelX.dkd, an in vitro diagnostic intended to aid in the assessment of risk of progressive kidney function decline in adult patients with Type 2 diabetes and existing chronic kidney disease. KidneyIntelX.dkd works by measuring three analyte components associated with kidney function decline from a patient’s plasma sample. The results of the three measured analytes are combined with three data inputs from the patient’s medical record provided by the ordering physician, and a machine-learning algorithm provides a risk category of low, moderate, or high. KidneyIntelX.dkd is not intended for screening or as a stand-alone diagnostic test. https://www.medicaldevice-network.com/news/renalytix-de-novo-authorisation-kidneyintelx-dkd-test/