FDA Cleared

We pride ourselves in working with the FDA to ensure safety and reliability for end customers.

Athelas was granted a FDA 510K Class 2 clearance for the Athelas One device. The system is cleared for point-of-care indications in the evaluation of WBC and NEUT%.

PUBLICATIONS

Clinically Validated

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.

Blood: Clinical Third Party Validation of the Athelas Device

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November 29, 2018

Ann. Clinical Psychiatry - Athelas and Clozapine

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May 1, 2021

FDA 510K Clearance Studies

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November 5, 2018

Athelas One Clozapine Cost Savings

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June 6, 2020

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