{"product_name":"SmartPatch","company_name":"Alio","product_url":"https://alio.ai","company_url":"https://alio.ai","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0376","summary":"Alio's SmartPatch is a non-invasive wearable device that continuously monitors key health metrics, providing real-time data to clinicians for proactive patient care.","description":"Alio's SmartPatch is a wearable device designed for continuous, non-invasive monitoring of vital health metrics, including potassium, hematocrit, hemoglobin, auscultation sounds, heart rate, and skin temperature. It wirelessly transmits data to a clinician-facing portal, enabling real-time insights and timely interventions. The device is particularly beneficial for patients with chronic conditions like end-stage kidney disease (ESKD), offering a less invasive alternative to traditional monitoring methods. Alio has secured FDA clearances for various metrics and has partnered with healthcare providers to enhance patient care through remote monitoring.","categories":["clinical Care","patient Facing","diagnostic Support","remote Monitoring","wearable Health Devices","Clinical","Patient-facing","Diagnostic","Remote Monitoring","Wearable Technology"],"market_segment":["Enterprise","SMB","Consumer"],"target_users":["Clinicians","Patients","Healthcare Providers","Care Teams"],"specialties":["Nephrology","Cardiology","Endocrinology","Pulmonology","General Medicine"],"regions_available":["United States","Saudi Arabia","Gulf Cooperation Council (GCC) countries","Other regions as per partnerships"],"languages_supported":["English","Arabic","Other languages as per regional partnerships"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United States","Saudi Arabia","Other countries as per partnerships"],"company_founding":"2018","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Non-invasive monitoring of potassium, hematocrit, hemoglobin, auscultation, heart rate, and skin temperature","Real-time, 24/7 remote patient monitoring","Clinical-grade data collection and sharing","FDA-cleared for home use settings","Automated notifications for atypical acoustic data from vascular access sites","Integration with healthcare professionals for improved patient care"],"optional_modules":["Data analytics dashboard","Patient engagement tools","Integration with electronic health records (EHR) systems"],"integrations":["Epic","Cerner","PACS","Billing systems"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED","ICD-10"],"api_available":"yes","system_requirements":"Ubuntu 22.04 LTS Server, 4-6 virtual CPUs, 8-32 GB RAM, 300GB - 1.4TB storage, 50 Mbps internet access","compliance":["HIPAA","FDA 510(k) clearance","SOC 2","ISO 27001"],"certifications":["FDA 510(k) clearance","CE/MDR","ONC","ISO 27001"],"security_features":["Encryption","RBAC","SSO/SAML","Audit logs","2FA","DLP"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0376","slug":"smartpatch","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/smartpatch.json"}}