{"product_name":"Biovitals Analytics Engine","company_name":"Biofourmis","product_url":"https://www.biofourmis.com/biovitals-analytics-engine","company_url":"https://www.biofourmis.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0546","summary":"Biovitals Analytics Engine is an AI-powered platform by Biofourmis that analyzes physiological data to predict health events, enabling proactive patient care.","description":"Biovitals Analytics Engine is a machine-learning and AI-driven platform that processes real-time physiological data, such as heart rate, respiratory rate, and activity, to build individualized biometric signatures. It computes a Biovitals Index to alert healthcare providers to changes in patients' vital signs, potentially weeks before adverse events occur, facilitating early intervention and improved patient outcomes. The platform is FDA-cleared for ambulatory physiological monitoring and is integrated into Biofourmis' digital therapeutics ecosystem, supporting chronic condition management and clinical research.","categories":["clinical Care","diagnostic Support","patient Facing","predictive Analytics","remote Monitoring","Clinical","Diagnostic","Patient-facing","Predictive Analytics","Remote Monitoring"],"market_segment":["Enterprise","SMB","Consumer"],"target_users":["Clinicians","Patients","Researchers","Pharmaceutical Companies","Payers"],"specialties":["Cardiology","Pulmonology","Oncology","Neurology","Endocrinology","Rheumatology","Geriatrics","Pediatrics","Obstetrics","Gynecology","Orthopedics","Gastroenterology","Hematology","Infectious Diseases","Nephrology","Urology","Dermatology","Ophthalmology","Psychiatry","Emergency Medicine"],"regions_available":["United States","Europe","Asia","Australia","Canada","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"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United States","Singapore","India","China","Japan","South Korea","Germany","United Kingdom","France","Australia"],"company_founding":"2015","deployment_model":["SaaS"],"os_platforms":["Web","iOS","Android"],"features":["Cloud-based configurable care-delivery platform","Cellular-enabled continuous and episodic device integrations","FDA-cleared AI-enabled analytics for digital biomarkers","In-home services coordination (diagnostics, DME, medications, transport, tech support)","User-facing dashboard and communication interface for patients and providers","Remote patient management and monitoring","Pre-built and disease-specific care pathways (70+)","Programs for Hospital-at-Home, SNF-at-Home, Timely Discharge"],"optional_modules":["Hospital-at-Home program","SNF-at-Home program","Transitional/Timely Discharge program","Remote Patient Management programs","Disease-specific care pathway packages"],"integrations":["EMR/EHR integration","Device/sensor ecosystem (cellular-enabled devices, medical-grade sensors)"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED","ICD-10"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA","GDPR","CCPA/CPRA","ISO 27001","SOC 2 Type II"],"certifications":["FDA 510(k)"],"security_features":["Encryption in transit and at rest","Role-based access controls","Audit logging","Two-factor authentication (2FA)"],"privacy_features":["PHI handling under HIPAA Notice of Privacy Practices","GDPR representative and EU data subject rights support","CCPA/CPRA consumer data rights support"],"data_residency":"Cloud-hosted with servers in multiple jurisdictions; multi-region/cloud options","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0546","slug":"biovitals-analytics-engine","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/biovitals-analytics-engine.json"}}