Athelas Home

by Athelas  · Based in United States → — AI to grow your healthcare business
Hematology Infectious Disease Oncology

Variable
Regulatory Status Disclosed

Overview

Athelas Home is an AI-powered, FDA-cleared, and CLIA-waived hematology analyzer designed for rapid white blood cell (WBC) and neutrophil percentage (NEUT%) monitoring. The device utilizes a small capillary fingerstick blood sample, which is processed on-site using automated image analysis and artificial intelligence to deliver quantitative results within minutes.

The system is designed for patients requiring frequent monitoring of immune status, particularly those undergoing immunosuppressive chemotherapy, patients with chronic neutropenia, and individuals on clozapine therapy for behavioral health conditions. It is utilized across oncology, psychiatry, and hematology specialties, as well as in community, mobile, and home care settings.

Athelas Home integrates into clinical workflows by enabling both point-of-care testing during patient visits and remote patient monitoring (RPM). Key capabilities and features include:

  • Rapid Turnaround: Generates quantitative WBC and neutrophil percentage results in minutes, reducing reliance on central laboratories.
  • Remote Data Transmission: Automatically transmits patient-collected test results directly to healthcare providers through secure software, keeping results hidden from the patient to ensure clinical oversight.
  • Abnormal Cell Flagging: Identifies and flags the presence of immature, blast, or other abnormal cell types.
  • REMS Integration: Seamlessly integrates with Clozapine REMS systems to streamline mandatory monitoring and medication dispensing workflows.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered hematology analyzer
  • Quantitative WBC and Neutrophil percentage results
  • Fingerstick sample collection
  • Point-of-care testing
  • Home use for patient self-testing
  • CLIA-waived device
  • Remote monitoring capabilities
  • AI-native diagnostics
  • Neural-network-based cell analysis
  • Computer vision for cell identification

Use Cases

  • High-frequency monitoring for chemotherapy patients
  • Monitoring for immunosuppressive therapies
  • Assessing infection risk
  • Behavioral health and clozapine monitoring
  • Neutropenia management
  • Reducing reliance on central labs for routine blood tests

What Physicians Need to Know

LIS/LIMS Integration
Athelas Home transmits quantitative WBC and Neutrophil percentage results directly to healthcare providers via its software platform. While not explicitly termed 'LIS/LIMS integration' for the device, Athelas, as a Commure company, offers EHR solutions and has demonstrated seamless integration with existing EHR systems for its Revenue Cycle Management (RCM) services, suggesting broader integration capabilities within healthcare IT ecosystems.
Supported Assay Types
Athelas Home is FDA-cleared and CLIA-waived for the quantitative determination of White Blood Cell (WBC) count and Neutrophil percentages (NEUT%) from capillary whole blood (fingerstick) for patient self-testing and in capillary or K2EDTA venous whole blood for point-of-care settings. It also calculates Absolute Neutrophil Count (ANC) to support monitoring workflows.
QC/QA Features
The system incorporates additional software and quality control safeguards specifically for at-home usage. It features Remote Lockout capabilities, allowing a healthcare provider or manufacturer to remotely disable a device for safety. Performance has been clinically validated, demonstrating comparability to traditional laboratory methods.
Result Interpretation AI
Athelas Home utilizes neural-network-based cell analysis and computer vision technology to identify and count cells from blood samples. This AI-powered system delivers clinically validated performance for hematology diagnostics.
Critical Value Alerts
While not explicitly described as 'critical value alerts,' the system provides real-time results directly to healthcare professionals for interpretation and analysis, enabling immediate clinical decisions and timely interventions for conditions like neutropenia. Results are not shown directly to end-patients.
Instrument Interfaces
The Athelas Home analyzer functions with proprietary Athelas Home test strips, which collect capillary whole blood samples via fingerstick. A compatible smartphone or tablet with the Athelas mobile application is required to initiate a test, and images are automatically transmitted to a cloud server for processing.
Reference Range Intelligence
Adult reference intervals for the Athelas One (which shares technology with Athelas Home) were verified against established reference intervals from a Sysmex XE-5000. It is emphasized that results from Athelas Home should not be the sole basis for patient diagnosis, treatment, or management, and all results require evaluation by a healthcare provider.
Turnaround Time Impact
The device delivers quantitative WBC and neutrophil results in minutes from a fingerstick sample, often in less than a minute. This rapid turnaround time supports same-visit clinical decisions, reduces missed monitoring, and minimizes treatment delays by eliminating the need to wait on central labs.
Physician Tip

Leverage Athelas Home's real-time WBC and ANC results for immediate clinical decision-making, particularly for patients undergoing chemotherapy, immunosuppressive therapies, or clozapine treatment, to facilitate timely interventions and dose adjustments. Utilize its point-of-care and home monitoring capabilities to enhance patient adherence to monitoring schedules and reduce the logistical burden of frequent lab visits. Always interpret Athelas Home results in conjunction with the patient's full clinical picture, as they are intended to quantify WBC and NEUT% and should not be the sole basis for diagnosis or treatment decisions. Consider the remote lockout feature for added safety in home-use scenarios, especially for vulnerable patient populations.

Athelas Home integrates with healthcare provider workflows by transmitting results directly to their software platform for review and analysis. The device requires a smartphone or tablet with the Athelas mobile application for operation, which then sends data to a cloud server. As part of Commure, Athelas's broader offerings include EHR solutions, suggesting potential for deeper integration within a comprehensive healthcare IT ecosystem. Their RCM system has demonstrated seamless integration with existing EHR systems, indicating a capability for interoperability.

Details

Category Lab & Diagnostics
Pricing Variable — Variable; depends on practice size, service bundle, and existing platform usage.
DeploymentCloud-based software with a physical diagnostic device for point-of-care and home use.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Athelas Home received FDA clearance (K200828) as a Class II, CLIA-waived automated differential cell counter on March 22, 2022. It is indicated for the quantitative determination of white blood cells (WBC) and Neutrophil percentages (NEUT%) in capillary whole blood for prescription use only.

Integrations
EHR Not specified
Specialties Hematology, Infectious Disease, Oncology

What the Web Says

Athelas Home offers remote patient monitoring and chronic care management, including at-home blood testing and AI-powered analysis for healthcare providers. It aims to streamline financial workflows, automate documentation, and enhance patient care. The system is FDA-cleared and CLIA-waived for white blood cell count and neutrophil percentage. Many users appreciate its ability to provide real-time insights and reduce administrative burdens.

Overall: Mixed

Strengths

  • Excellent benefits and work-life balance for employees.
  • Decent pay and flexible schedules for employees.
  • Friendly work environment with dedicated workers.
  • Potential to disrupt the Revenue Cycle Management (RCM) industry.
  • Seamless transition and immediate results for practices using RCM.
  • Devices are easy to use and provide personalized care for patients.

Limitations

  • Poor and inexperienced management with a lack of career growth opportunities.
  • No job security or longevity, with quick hiring and firing practices.
  • High pressure and expectations, with reports of favoritism.
  • Ethically questionable practices have been mentioned.
  • Sales team can be unresponsive or dishonest.
  • Product has major issues and changes functions without notice.

Based on reviews from: TenereTeam, Athelas.com, Apple App Store, Indeed.com, G2, Reddit, Capterra

Last updated: 2026-07-20

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Press & Coverage

Athelas Insights
Athelas Home Expands AI Diagnostics to the Point of Care with FDA Clearance
Athelas, a Commure company, announced FDA clearance for its CLIA-waived Athelas Home diagnostic device for point-of-care use, enabling AI-powered hematology analysis from a fingerstick in minutes. This expands its use beyond home settings to support immediate clinical decisions for high-risk patients.
2026-02
Clinical Lab Products
FDA Clears Athelas Home AI Blood Test for Point-of-Care Settings | Clinical Lab Products
The FDA has cleared Athelas' CLIA-waived Athelas Home AI-powered hematology analyzer for point-of-care use, allowing providers and pharmacies to perform white blood cell testing from fingerstick samples without central labs. The device uses neural-network-based cell analysis and computer vision.
2026-02
Global Digital Health News
Athelas Home Secures FDA Clearance to Expand AI Diagnostics Into Point-of-Care Settings
Athelas, a Commure company, received FDA clearance for its Athelas Home diagnostic device for point-of-care settings, expanding its AI-powered hematology testing beyond home use. This enables same-visit testing for white blood cell and neutrophil percentage results from a fingerstick.
2026-02
360Dx
Athelas Nabs FDA Clearance for Point-of-Care Hematology Analyzer - 360Dx
AI firm Athelas announced FDA clearance for its Athelas Home hematology analyzer for use in point-of-care settings. The device utilizes neural network-based cell analysis and computer vision to identify and count cells.
2026-02
Innolitics (FDA 510(k) Database)
Athelas Home (K243348) u2014 FDA 510(k) - Innolitics
This FDA 510(k) summary details the clearance for Athelas Home, expanding its use to point-of-care settings and adding K2EDTA venous whole blood as a sample type. It is indicated for quantitative determination of WBC and Neutrophil percentages.
2026-02
ASH Publications (Blood)
Home monitoring of neutrophil counts by patients with cyclic and congenital neutropenia | Blood | American Society of Hematology - ASH Publications
This article discusses a study on the Athelas Home device for monitoring neutrophil counts in patients with cyclic and congenital neutropenia. The device allows patients to perform home monitoring with fingerstick blood, providing convenience and rapid results.
2025-11
Medium (Sequenex)
Advancements In Sensors for Remote Patient Monitoring | by Sequenex | Medium
Athelas Home is highlighted as a connected blood diagnostics device that reads neutrophil and white blood cell levels from a few drops of blood, with results transferred to EHRs. It helps patients on Clozapine or chemotherapy track blood counts from home.
2023-11
Athelas Blog
Announcing the landmark FDA Clearance of the Athelas Home.
Athelas announced FDA clearance for its Athelas Home device for home-use indication in April 2022. The device measures White Blood Cells and Neutrophil percentages remotely and can flag abnormal cell types, aiding in the management of chronically ill patients.
2022-04

Videos

Product demos, reviews, and walkthroughs for Athelas Home.

View all on YouTube

Frequently Asked Questions

Athelas Home employs neural-network-based cell analysis and computer vision to identify and count cells from a fingerstick blood sample. This AI-powered hematology analyzer provides rapid, clinically validated white blood cell (WBC) and neutrophil percentage (NEUT%) results in minutes, enabling timely clinical decisions at the point of care or in a patient's home.
Athelas Home is particularly beneficial for high-risk patients requiring frequent monitoring, such as those undergoing chemotherapy, receiving immunosuppressive therapies, or at risk of infection. It is also a key tool for managing patients on clozapine therapy, where regular Absolute Neutrophil Count (ANC) testing is crucial for safety.
Athelas explicitly states that its entire ecosystem, including Athelas Home, is HIPAA compliant, committing to protecting patient data. Their privacy practices are intended to comply with HIPAA and relevant state laws, collecting health and device data solely for providing services and medical treatment.
While Athelas Home specifically focuses on AI-powered hematology analysis from fingerstick samples, general remote patient monitoring (RPM) alternatives include companies like HealthSnap, Optimize Health, Cadence, and Teladoc Health, which offer broader vital sign monitoring. Athelas Home differentiates itself by providing rapid, lab-grade blood count results directly at the point of care or home, reducing reliance on central labs for specific diagnostic needs.
Athelas Home is indicated for quantitative determination of WBC and NEUT% in capillary whole blood for adult populations (aged 21 and older) and is for prescription use only. Results should not be the sole basis for patient diagnosis, treatment, or management of leukopenia and neutropenia, and all results require evaluation by a healthcare provider.
Athelas Home has received FDA clearance for its AI-native diagnostic device after four years of regulatory engagement to validate its performance in clinical environments. It uses neural-network-based cell analysis and computer vision to deliver consistent, clinically validated results comparable to traditional laboratory methods.
While specific pricing details for physician practices are not publicly available in the search results, Athelas Home is positioned to help practices generate new revenue streams through remote patient monitoring. The service is often covered by Medicare, Medicare Advantage, most PPOs, and some HMOs, with Athelas performing eligibility checks for patients.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20

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