Working with the FDA from Day One
Athelas has collected large amounts of clinical data about device performance. The system is now FDA Cleared for point-of-care indications in the evaluation of WBC and NEUT%.
FDA
Cleared
Athelas has conducted clinical studies meant to show equivalence to predicate devices for the WBC and Neut% parameters in the point-of-care. The system is now FDA Cleared.
Externally Validated
Precision and Accuracy
We take accuracy and transparency seriously. Read our third-party clinical white paper on the accuracy of our capillary WBC and Neutrophil results versus venous blood samples on the Sysmex XE-5000.
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