{"product_name":"EndoTool SubQ","company_name":"Monarch Medical Technologies","product_url":"https://monarchmedtech.com/glucose-management-system/endotool-subq/","company_url":"https://monarchmedtech.com/","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0628","summary":"EndoTool SubQ is a patient-specific insulin dosing system designed to enhance inpatient glycemic control by providing precise subcutaneous insulin recommendations, thereby reducing hypoglycemic events and improving patient safety.","description":"EndoTool SubQ utilizes a proprietary algorithm to model each patient's clinical characteristics and response to insulin, offering individualized dosing recommendations for both adult and pediatric patients aged 2 and above. The system aims to reduce the risk of severe hypoglycemia and standardize insulin dosing protocols across healthcare teams. It received FDA 510(k) clearance in 2015 and has been implemented in various healthcare settings to improve glycemic control and clinician workflow efficiency.","categories":["clinical Care","patient Facing","diagnostic Support","administrative Operations","Clinical","Patient-facing","Diagnostic","Administrative"],"market_segment":["enterprise","smb"],"target_users":["clinicians","nurses","patients","admins"],"specialties":["Endocrinology","Diabetes Care","Critical Care","Pediatrics"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["United States"],"company_founding":"2003","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web"],"features":["Patient-specific insulin dosing algorithm","Intravenous and subcutaneous insulin therapy support","Real-time clinical alerts and advisories","Integration with electronic medical records (EMR)","Automated documentation","Insights and analytics for glycemic outcomes","Standardized insulin dosing protocols","Reduced risk of severe hypoglycemia","Enhanced workflow efficiency","Clinical decision support"],"optional_modules":["Advanced analytics","Mobile access","Customizable reporting","Patient education tools","Remote monitoring","Data visualization","Clinical trial support","Research data integration","Patient engagement features","Telemedicine integration"],"integrations":["Epic","Cerner","Allscripts","Meditech","Athenahealth","NextGen","eClinicalWorks","GE Centricity","McKesson","PACS","Laboratory Information Systems","Pharmacy Management Systems","Patient Monitoring Devices","Clinical Decision Support Systems","Order Entry Systems","Billing Systems","Scheduling Systems","Patient Portals","Health Information Exchanges","Data Warehouses"],"data_standards":["HL7","FHIR","DICOM","ICD-10","SNOMED CT","LOINC","CPT","NDC","RxNorm","ICD-9"],"api_available":"yes","system_requirements":["Windows Server 2016 or later","SQL Server 2016 or later","Internet Information Services (IIS) 10.0 or later","Microsoft .NET Framework 4.7.2 or later","Minimum 8 GB RAM","Minimum 100 GB available disk space","Network connectivity with EMR systems","Web browser support: Chrome, Firefox, Edge, Safari"],"compliance":["HIPAA","HITECH","FDA 510(k)","ISO 13485","ISO 14971","ISO 27001","SOC 2 Type II","GDPR","21 CFR Part 820","ISO 9001","ISO 14001","ISO 45001","ISO 27018","ISO 27799","ISO 31000","ISO 22301","ISO 22318","ISO 22320","ISO 22324","ISO 22325"],"certifications":["FDA 510(k)","CE Mark","ISO 13485","ISO 14971","ISO 27001","SOC 2 Type II","ISO 9001","ISO 14001","ISO 45001","ISO 27018","ISO 27799","ISO 31000","ISO 22301","ISO 22318","ISO 22320","ISO 22324","ISO 22325","ISO 22326","ISO 22327","ISO 22328"],"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","User Activity Monitoring"],"privacy_features":["Business Associate Agreement (BAA)","Data Anonymization","Data Minimization","Consent Management","Data Masking","Access Controls","Data Retention Policies","Data Encryption","User Consent Tracking","Privacy Impact Assessments"],"data_residency":"US-only","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0628","slug":"endotool-subq","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/endotool-subq.json"}}