{"product_name":"HeartFocus","company_name":"DESKi","product_url":"https://www.heartfocus.ai","company_url":"https://www.heartfocus.ai","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0053","summary":"HeartFocus is an AI-driven cardiac imaging software developed by DESKi, enabling healthcare professionals to perform diagnostic-quality heart ultrasounds with minimal training.","description":"HeartFocus is an FDA-cleared AI-powered cardiac imaging software developed by DESKi, a French medtech company. It integrates with handheld ultrasound devices, allowing healthcare professionals to conduct diagnostic-quality heart ultrasounds after just a few hours of training. The software aims to address the global shortage of trained sonographers and cardiologists by enabling non-specialists to perform comprehensive echocardiographic assessments. It has been validated through international clinical trials, demonstrating that novice users can achieve results comparable to expert sonographers. HeartFocus is now available in the U.S. market through a partnership with Butterfly Network, expanding access to cardiac diagnostics in various healthcare settings, including hospitals, primary care clinics, and educational institutions.","categories":["clinical Care","diagnostic Support","patient Facing","imaging Software","cardiology","Clinical","Diagnostic","Patient-facing","Imaging","Cardiology"],"market_segment":["Enterprise","SMB","Consumer"],"target_users":["Clinicians","Nurses","Patients","Admins","Payers"],"specialties":["Cardiology"],"regions_available":["United States","France","Europe","North America","South America","Asia","Africa","Australia","New Zealand","Middle East"],"languages_supported":["English","French","Spanish","German","Italian","Portuguese","Dutch","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Urdu","Turkish","Vietnamese","Thai","Polish"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["France","United States","Germany","United Kingdom","Canada","Australia","India","China","Japan","Brazil"],"company_founding":"2023","deployment_model":["SaaS"],"os_platforms":["iOS"],"features":["AI-guided cardiac ultrasound imaging","Real-time on-screen prompts for probe positioning","Automatic recording of diagnostic-quality clips","Live feedback on image quality","Support for 10 standard echocardiographic views","DICOM integration with PACS systems","HIPAA-compliant workflows","FDA-cleared for use in the United States","Compatible with Butterfly iQ+ and iQ3 probes","Designed for use in primary care, emergency settings, hospitals, and rural clinics"],"optional_modules":["HeartFocus Education app"],"integrations":["Butterfly iQ+","Butterfly iQ3","PACS systems"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"iOS device with Butterfly iQ+ or iQ3 probe","compliance":["HIPAA"],"certifications":["FDA clearance"],"security_features":["End-to-end encryption","Audit trails","Access controls","Regular security reviews","Penetration testing","Coordinated Vulnerability Disclosure (CVD)"],"privacy_features":["Data anonymization","User data control","Data retention policies"],"data_residency":"Data stored in compliance with U.S. regulations","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0053","slug":"heartfocus","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/heartfocus.json"}}