{"product_name":"Caption Guidance","company_name":"Caption Health","product_url":"https://www.captionhealth.com/user-documents","company_url":"https://www.captionhealth.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0495","summary":"Caption Guidance is an AI-powered software that enables healthcare providers, even without prior ultrasound experience, to perform diagnostic-quality cardiac ultrasound exams by providing real-time guidance and automated interpretation.","description":"Caption Guidance, developed by Caption Health, is the first FDA-authorized AI-guided image acquisition system for cardiac ultrasound. It assists healthcare professionals in capturing high-quality ultrasound images by offering real-time guidance and automated quality assessments, making ultrasound accessible to a broader range of clinicians and improving patient care.","categories":["clinical Care","imaging Software","cardiology","clinical Decision Support","Clinical","Diagnostic Imaging","Cardiology","Medical Ai"],"market_segment":["Enterprise","SMB","Consumer"],"target_users":["Clinicians","Nurses","Physicians","Healthcare Providers"],"specialties":["Cardiology","Emergency Medicine","Anesthesiology","Critical Care"],"regions_available":["United States","Europe","Asia","Australia","Canada","South America","Africa","Middle East","India","China"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Dutch","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Urdu","Tamil","Telugu","Marathi","Gujarati"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United States","United Kingdom","Germany","France","India","China","Japan","Australia","Canada","Brazil"],"company_founding":"2016","deployment_model":["SaaS"],"os_platforms":["Web"],"features":["AI-guided ultrasound image acquisition","Diagnostic-quality cardiac ultrasound imaging","FDA-cleared medical device software","Breakthrough Device designation from FDA","NTAP authorization from CMS for Medicare patients","Integration with GE Healthcare Venue Family ultrasound devices","Integration with Butterfly iQ+ ultrasound devices","Integration with Terason uSmart 3200T ultrasound devices","Supports multiple ultrasound devices","Real-time image guidance for healthcare providers","Improves access to ultrasound diagnostics","Enhances clinical decision-making","Facilitates point-of-care ultrasound imaging","Supports heart failure diagnosis","Supports stroke diagnosis","Supports pericardial effusion detection","Supports left ventricular size assessment","Supports left ventricular function assessment","Supports right ventricular size assessment","Supports pericardial effusion assessment"],"optional_modules":["Advanced image analysis tools","Cloud-based data storage","Remote image review capabilities","Patient data management features","Clinical workflow integration tools","Telemedicine support","Automated reporting features","Training and education resources","Clinical decision support tools","Patient monitoring integration"],"integrations":["GE Healthcare Venue Family ultrasound devices","Butterfly iQ+ ultrasound devices","Terason uSmart 3200T ultrasound devices"],"data_standards":["DICOM","HL7","ICD-10","SNOMED CT","LOINC","CPT","ICD-9","HL7 CDA","HL7 CCD","HL7 FHIR"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA","FDA 21 CFR Part 820","FDA 21 CFR Part 11","ISO 13485","ISO 14971","IEC 62304","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8"],"certifications":["FDA 510(k)","CE Marking","ISO 13485","ISO 14971","IEC 62304","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8","IEC 60601-1-11"],"security_features":["Data encryption","Access control","Audit trails","User authentication","Data integrity checks","Secure data transmission","Regular security assessments","Compliance with security standards","Incident response plan","Data backup and recovery"],"privacy_features":["Data anonymization","Data minimization","User consent management","Data access controls","Data retention policies","Compliance with privacy regulations","Patient data confidentiality","Data sharing agreements","Data breach notification procedures","Third-party risk assessments"],"data_residency":"US and EU data centers","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0495","slug":"caption-guidance","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/caption-guidance.json"}}