{"product_name":"DeepRhythmAI","company_name":"Medicalgorithmics","product_url":"https://www.medicalgorithmics.com/products/drai-old/","company_url":"https://www.medicalgorithmics.com/","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0011","summary":"DeepRhythmAI (DRAI) is an FDA-cleared AI-powered solution by Medicalgorithmics for rapid and accurate ECG analysis, enhancing arrhythmia detection and diagnosis efficiency.","description":"DeepRhythmAI (DRAI) is a cloud-based artificial intelligence algorithm developed by Medicalgorithmics for autonomous ECG analysis. It processes multichannel Holter, Event, and Mobile Cardiac Telemetry data to detect and classify a wide range of cardiac arrhythmias, including atrial fibrillation and ventricular tachycardia. DRAI integrates seamlessly into existing healthcare workflows and devices, providing results within minutes, thereby improving operational efficiency and patient care. It has received FDA clearance under 510(k) number K210822, marking it as one of the few AI-enabled medical devices approved for cardiac rhythm analysis. ([www-next.medicalgorithmics.com](https://www-next.medicalgorithmics.com/products/drai/?utm_source=openai))","categories":["clinical Care","diagnostic Support","cardiology","ai Clinical Documentation Integrity","clinical Decision Support","medical Device","cardiac Monitoring","regulatory Compliance","cloud-based Solutions","data Integration","cardiac Monitoring","clinical Decision Support","Clinical","Diagnostic","Cardiology","Artificial Intelligence","Medical Device","Ecg Analysis","Fda Cleared","Cloud-based","Healthcare Integration","Arrhythmia Detection"],"market_segment":["Enterprise","SMB","Consumer"],"target_users":["Clinicians","Cardiologists","Healthcare Professionals","Medical Technicians","Patients"],"specialties":["Cardiology","Electrocardiography","Arrhythmia Detection","Cardiac Monitoring","Telemedicine","Medical Imaging","Artificial Intelligence In Healthcare","Medical Device Integration","Fda Cleared Medical Devices","Cloud-based Healthcare Solutions"],"regions_available":["United States","European Union","Poland","Global"],"languages_supported":["English","Polish","Other European Languages"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["Poland","United States","European Union","Other Global Locations"],"company_founding":"2005","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Cloud-based ECG data analysis","AI-powered arrhythmia detection","Automated ECG interpretation","High diagnostic precision","Scalability for various healthcare organizations","Intuitive user interface","Remote monitoring capabilities","Data security with ISO/IEC 27001 certification","Workflow automation to minimize manual reviews","Integration with various ECG recorders"],"optional_modules":["Advanced reporting tools","Customizable alert systems","Patient data analytics","Integration with hospital information systems","Telemedicine support","Mobile health applications","Clinical decision support","Patient engagement tools","Data visualization dashboards","Predictive analytics for arrhythmia risk assessment"],"integrations":["Holter monitors","Event recorders","Outpatient telemetry systems","Hospital information systems","Telemedicine platforms","Mobile health applications","Clinical decision support systems","Patient engagement tools","Data visualization dashboards","Predictive analytics platforms"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED","ICD-10"],"api_available":"yes","system_requirements":"Major OS/DB/hardware needs, or empty if SaaS-only","compliance":["HIPAA","GDPR","HITECH","SOC 2","ISO 27001"],"certifications":["FDA 510(k)","CE/MDR","ONC","ISO"],"security_features":["Encryption","RBAC","SSO/SAML","audit logs","2FA","DLP"],"privacy_features":["BAA available","consent mgmt","anonymization","data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0011","slug":"deeprhythmai","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/deeprhythmai.json"}}