Athelas Home Secures FDA Clearance to Expand AI Diagnostics Into Point-of-Care Settings

The device delivers clinically validated white blood cell (WBC) and neutrophil percentage (NEUT%) results from a fingerstick sample within minutes. 

Athelas, a Commure company, has received clearance from the U.S. Food and Drug Administration to use its CLIA-waived Athelas Home diagnostic device in point-of-care settings, expanding its AI-powered hematology testing beyond home use.

The device delivers clinically validated white blood cell (WBC) and neutrophil percentage (NEUT%) results from a fingerstick sample within minutes. The clearance enables ambulatory providers and pharmacies to conduct same-visit testing, supporting immediate clinical decision-making without reliance on central laboratories.

According to the company, the clearance follows four years of regulatory engagement with the U.S. Food and Drug Administration to validate AI-native diagnostics for clinical environments. The device uses neural-network-based cell analysis and computer vision to identify and count blood cells, aiming to deliver lab-grade performance in decentralized settings.

The platform is designed for patients requiring frequent monitoring, including those undergoing chemotherapy, receiving immunosuppressive therapies, or at risk of infection. With the expanded authorization, providers can now monitor high-risk patients across both home and clinical settings using the same diagnostic system.

The company stated that the move addresses logistical barriers in high-acuity care, particularly in oncology and clozapine therapy management. Providers can perform Absolute Neutrophil Count (ANC) testing during routine visits, enabling compliance with safety monitoring requirements and reducing treatment delays. Real-time results are intended to streamline workflows by completing testing and clinical evaluation within a single appointment.

“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.”

Nicholas Eisemann-Astone, PMHNP-BC, MSN, BS, RN, CCM, of Cactus Garden Mental Health Services, said the device has enabled in-clinic clozapine monitoring, allowing providers to conduct fingerstick ANC testing alongside routine vitals during a single visit.

Athelas Home is now available for deployment in point-of-care settings nationwide. Financial terms or commercial rollout details were not disclosed.

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