Go ahead,
FACT 1
Not all early risk assessment “solutions” are the same, even though their claims may seem similar.
FACT 2
KidneyIntelXTM has received the first Breakthrough Device Designation from the FDA (publicly announced by any company) for an AI-enabled prognostic for kidney disease.
FACT 3
Renalytix is voluntarily pursuing a rigorous FDA review and marketing authorization process for KidneyIntelX.
For more information about our scientific standards and rigor, click Labs & Quality.