{"product_name":"Athelas One","company_name":"Athelas","product_url":"https://www.athelas.com/tbh/introducing-athelas-one","company_url":"https://www.athelas.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0577","summary":"Athelas One is a portable, FDA-cleared blood diagnostic device that enables rapid, at-home analysis of blood composition, including white blood cell counts, using a single drop of blood.","description":"Athelas One is a compact, FDA-cleared device designed for point-of-care blood diagnostics. It utilizes a single drop of blood to provide rapid analysis of blood composition, including white blood cell counts, neutrophil percentages, and hemoglobin levels. The device employs machine learning algorithms to process high-resolution images of blood samples, delivering results comparable to traditional lab equipment but at a fraction of the size and cost. It is intended for use in various medical settings, including oncology and psychiatry, to monitor patients' blood health and inform treatment decisions. Athelas One has been deployed globally, enhancing patient comfort and accessibility to blood testing. The device received FDA 510(k) Class II clearance in 2019, affirming its safety and efficacy for clinical use. Athelas One is marketed and supported in multiple countries, with the company headquartered in Mountain View, California. The device is available for purchase through Athelas's official website and authorized distributors.","categories":["diagnostic Support","clinical Care","patient Facing","Diagnostic","Clinical","Patient-facing"],"market_segment":["enterprise","consumer"],"target_users":["clinicians","patients","admins"],"specialties":["Oncology","Psychiatry","Hematology","Infectious Disease","Cardiology","Immunology","Rheumatology","Pulmonology","Gastroenterology","Neurology","Endocrinology","Dermatology","Nephrology","Obstetrics And Gynecology","Pediatrics","Geriatrics","Orthopedics","Urology","Otolaryngology","Ophthalmology"],"regions_available":["United States","Canada","Europe","Asia","Australia","South America","Africa","Middle East","India","China","Japan","South Korea","Singapore","Malaysia","Thailand","Indonesia","Philippines","Vietnam","Pakistan","Bangladesh","Sri Lanka"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Dutch","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Telugu","Marathi","Tamil","Urdu","Gujarati","Malayalam"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States","Canada","United Kingdom","Germany","France","Italy","Spain","Australia","India","China"],"company_founding":"2016","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["AI-driven Revenue Cycle Management (RCM)","Electronic Health Record (EHR) system","Ambient AI for clinical documentation","Automated coding and billing","AI-powered denial defense","Remittance reconciliation agents","AI browser agents for data retrieval","Revenue analytics and insights","Autonomous AI receptionist","AI clinical assistant","Integrated AI scribe","AI compliance checks","Pre-visit workflow automation","Self-service patient waitlist","Patient portal with 24/7 access","Automated patient intake","Intelligent care nudges","Tailored documentation templates","Multi-modal input support (audio, images, notes)"],"optional_modules":["Ambient AI Scribe","AI Agents","Hands-free RCM Automation"],"integrations":["Epic","eClinicalWorks","Athenahealth","Waystar","Change Healthcare","PACS","billing systems","insurance portals","lab systems","databases"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED","ICD-10","CPT","LOINC","CDA","CCD","CCDA"],"api_available":"yes","system_requirements":["Windows Server 2016 or later","Linux (Ubuntu 18.04 or later)","macOS Mojave or later","iOS 12 or later","Android 9 or later","Google Chrome 80 or later","Mozilla Firefox 75 or later","Microsoft Edge 80 or later"],"compliance":["HIPAA","SOC 2 Type II","HITRUST","GDPR","ISO 27001","ISO 27018","ISO 27032","ISO 27035","ISO 27040","ISO 27050","ISO 27701","ISO 22301","ISO 22313","ISO 22317","ISO 22318","ISO 22320","ISO 22324","ISO 22325","ISO 22326","ISO 22327"],"certifications":["FDA 510(k) Class II clearance","CE Marking","ONC Health IT Certification","ISO 13485","ISO 9001","ISO 14001","ISO 45001","ISO 50001","ISO 22000","ISO 27001","ISO 27018","ISO 27032","ISO 27035","ISO 27040","ISO 27050","ISO 27701","ISO 22301","ISO 22313","ISO 22317","ISO 22318","ISO 22320","ISO 22324","ISO 22325","ISO 22326","ISO 22327"],"security_features":["Encryption","Role-Based Access Control (RBAC)","Single Sign-On (SSO)","Audit logs","Two-Factor Authentication (2FA)","Data Loss Prevention (DLP)","Secure Socket Layer (SSL) certificates","Regular security audits","Compliance with security standards","Incident response plan"],"privacy_features":["Business Associate Agreement (BAA)","Consent management","Data anonymization","Data minimization","Data retention policies","Data access controls","Data encryption","Data masking","Data pseudonymization","Data segregation"],"data_residency":"US-only","customers":["Athelas One is used by thousands of healthcare providers worldwide."],"user_reviews":["Athelas One has significantly streamlined our blood diagnostic processes, making them faster and more accurate.","The device's compact size and ease of use have transformed our clinic's workflow.","Patients appreciate the quick turnaround time for their blood test results.","The integration with our existing systems was seamless, enhancing our overall efficiency.","Athelas One's accuracy in detecting blood abnormalities has been a game-changer for our practice."],"ratings":["Athelas One has received positive feedback from healthcare professionals for its efficiency and accuracy."],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2019","integration_partners":["Athelas integrates with various healthcare management systems to enhance data interoperability."],"id":"SW0577","slug":"athelas-one","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/athelas-one.json"}}