Athelas One
Overview
Athelas One is a compact, FDA-cleared, AI-powered blood diagnostics tool designed for point-of-care and clinical laboratory settings. It performs quantitative determination of white blood cell (WBC) counts and neutrophil percentages (NEUT%) from a single drop of capillary or venous whole blood in approximately 3 minutes. The device utilizes machine learning and computer vision to analyze high-resolution images of blood samples, delivering results comparable to traditional laboratory equipment. Intended for in vitro diagnostic use in adult populations (aged 21 and older) and available by prescription only, Athelas One is used to monitor patient blood composition for diagnosis and treatment direction, particularly in specialties like oncology and psychiatry. It is a foundational device that supports Athelas’ broader mission of bringing advanced healthcare diagnostics to accessible settings.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered blood diagnostics
- Rapid 3-minute results for WBC and NEUT%
- Requires only a single drop of capillary or venous blood
- Portable and compact design
- Machine learning and computer vision for cell analysis
- Comparable accuracy to traditional lab analyzers
- Suitable for point-of-care and clinical laboratory settings
- Mobile application for operation and result viewing
- Automated calibration
- Prescription use only
Use Cases
- Monitoring blood composition for diagnosis and treatment direction
- Oncology and infusion care (chemotherapy monitoring)
- Immunosuppressive therapy monitoring
- Clozapine monitoring in behavioral health
- Early detection of conditions like leukemia and infections
- Reducing missed monitoring and treatment delays
What Physicians Need to Know
Athelas One offers rapid, point-of-care (POC) hematology analysis, particularly for WBC and neutrophil counts, which is invaluable for managing high-risk patients (e.g., oncology, immunosuppression, clozapine therapy). The ability to perform fingerstick tests at the POC or even at home (with Athelas Home) significantly reduces patient burden, logistical challenges, and enables immediate treatment decisions. Physicians can leverage the quick results for same-visit care adjustments and to improve patient adherence to monitoring protocols.
Athelas One operates within a connected ecosystem. The device transmits data to a HIPAA-compliant cloud dashboard for physician access. Athelas also provides broader healthcare IT solutions, including Revenue Cycle Management (RCM) and Electronic Health Record (EHR) systems, with its RCM system designed to integrate with existing EHRs. The device itself interfaces with a mobile application for operation and result display, indicating a robust digital integration strategy.
Details
| Category | Lab & Diagnostics |
| Pricing | Contact vendor for pricing — Not publicly disclosed |
| Deployment | On-premise device with cloud-based data transmission |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
Yes AI-estimated Athelas One received 510(k) Class II clearance (K181288) on November 5, 2018. It is indicated for quantitative determination of white blood cells (WBC) and neutrophil percentages (NEUT%) in capillary or K2EDTA venous whole blood for in vitro diagnostic use in clinical laboratories and point-of-care settings for adult populations (aged 21 and older). |
| Integrations | |
| EHR | Not specified |
| Specialties | Hematology, Laboratory Medicine, Oncology |
What the Web Says
Athelas One is a 3-minute blood diagnostics tool that analyzes a single drop of blood to determine the concentration of different white blood cells (WBCs), including neutrophils, lymphocytes, and platelets, and can also measure hemoglobin. It aims to make bloodwork more comfortable for patients and more accessible for doctors, particularly for monitoring chronic conditions and chemotherapy patients. While praised for its innovative approach to in-home blood testing and remote patient monitoring, some users have raised concerns about the accuracy of its AI functions, the efficiency of its RCM services, and overall company management.
Overall: MixedStrengths
- Provides rapid WBC and neutrophil results from a fingerstick, making it convenient for patients and doctors.
- Clinically validated and received 510(k) Class II clearance, indicating accuracy comparable to traditional lab equipment.
- Enables real-time treatment decisions and reduces the burden of frequent lab visits for patients, especially those undergoing chemotherapy.
- Offers automated documentation and workflows with AI Healthcare Scribe, potentially decreasing charting time.
- Strong RCM (Revenue Cycle Management) team noted for professionalism and efficient launch processes, leading to quicker payments and fewer denials.
- HIPAA compliant for patient data storage and privacy.
Limitations
- AI function for notes and documentation can have errors, requiring significant editing.
- Transitioning to Athelas can be problematic, with issues like patient records not transferring correctly.
- Changes in the notes section occur without notice, which can be frustrating for users.
- The measures section is often disorganized and takes up too much space, leading some users to avoid it.
- Sales and support experiences have been described as poor, with unresponsiveness and a lack of transparency.
- Concerns about inaccurate results for abnormal cell detection and comparisons to past controversial blood testing companies like Theranos have been raised by medical professionals.
Based on reviews from: G2, Reddit, Capterra, Athelas.com, Birdeye, Indeed.com, YouTube, CCN Health
Last updated: 2026-07-18
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Athelas One - Test Strip Demo
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