The device delivers white blood cell counts from fingerstick samples in minutes, expanding monitoring capabilities for high-risk patients.
The US Food and Drug Administration (FDA) has cleared Athelas’ CLIA-waived Athelas Home AI-powered hematology analyzer for point-of-care use, enabling ambulatory providers and pharmacies to perform white blood cell testing without sending samples to central laboratories.
The device uses neural-network-based cell analysis and computer vision to deliver white blood cell and neutrophil percentage results from fingerstick samples in minutes. The clearance follows four years of regulatory engagement to validate AI-native diagnostics in clinical environments.
“We have spent years working through the FDA regulatory process to prove that AI can deliver lab-grade results in any environment,” says Tanay Tandon, CEO of Athelas, in a release. “One device now follows the patient from the living room to the clinic, ensuring data is available the moment care happens.”
The device was already in use by tens of thousands of patients in home settings, according to a release from the company. The point-of-care clearance extends its reach to clinical environments where same-visit testing can support immediate clinical decisions.
Supporting High-Risk Patient Monitoring
The platform targets patients requiring frequent monitoring for chemotherapy, immunosuppressive therapies, and infection risk management. Care teams can now monitor these high-risk patients across both home and point-of-care settings using a single platform.
The technology addresses logistical barriers in high-stakes medication and disease state management, particularly in oncology and clozapine therapy, where regular blood monitoring is required for patient safety.
“The Athelas Home has been transformative for our clinical practice,” says Nicholas Eisemann-Astone, PMHNP-BC, MSN, BS, RN, CCM, of Cactus Garden Mental Health Services, in a release. “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.”
AI-Native Diagnostic Technology
The device represents a shift toward AI-native diagnostics that can function consistently across different environments. The neural-network-based analysis system identifies and counts cells using computer vision technology, delivering what the company describes as clinically validated performance comparable to traditional laboratory methods.
Athelas Home is now available for deployment in point-of-care settings nationwide. The company, which operates as part of Commure, provides AI infrastructure for healthcare including revenue cycle management, ambient AI, electronic medical record solutions, and diagnostics.
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