MOUNTAIN VIEW, Calif., Feb. 12, 2026 (GLOBE NEWSWIRE) — Athelas, a Commure company, today announced that the FDA cleared the CLIA-waived Athelas Home diagnostic device for use in point-of-care settings. The AI-powered hematology analyzer is used by tens of thousands of patients and now enables same-visit testing to support clinical decisions without reliance on central labs.
Ambulatory providers and pharmacies can now deliver clinically validated white blood cell (WBC) and neutrophil percentage (NEUT%) results from a fingerstick in minutes. Care teams can monitor high-risk patients across home and point-of-care settings using a single platform.
Neural-Network Based Cell Analysis
This clearance follows four years of regulatory engagement with the FDA to validate AI-native diagnostics in clinical environments. Athelas Home uses neural-network-based cell analysis and computer vision to identify and count cells, delivering consistent, clinically validated performance.
The platform supports patients who need frequent monitoring for chemotherapy, immunosuppressive therapies, and infection risk. With this clearance, Athelas Home now extends that capability into point-of-care settings.
Operational Impact for High-Risk Care
Expanding into point-of-care settings reduces key logistical barriers to high-stakes medication and disease state management, particularly in oncology and Clozapine therapy:
“We have spent years working through the FDA regulatory process to prove that AI can deliver lab-grade results in any environment,” said Tanay Tandon, CEO of Athelas. “One device now follows the patient from the living room to the clinic, ensuring data is available the moment care happens.”
“The Athelas Home has been transformative for our clinical practice,” said Nicholas Eisemann-Astone, PMHNP-BC, MSN, BS, RN, CCM, of Cactus Garden Mental Health Services. “This technology has enabled clozapine for patients who had no other options. We can run a finger stick ANC right alongside the patient vitals. We can test, decide, and treat in one visit. No outside lab orders or coordinating extra transportation.”
Athelas Home is now available for deployment in point-of-care settings nationwide. To view technical documentation and request a demonstration, visit www.athelas.com/ahome.
About Athelas
Athelas, a Commure company, provides the AI-native infrastructure for modern healthcare. The company specializes in revenue cycle management, ambient AI, and electronic medical record solutions , and diagnostics that streamline healthcare operations and improve patient outcomes.
Media Contact
Dan Warner
daniel.warner@getathelas.com
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