{"product_name":"DeepEcho","company_name":"DeepEcho","product_url":"https://deepecho.io","company_url":"https://deepecho.io","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0015","summary":"DeepEcho is an AI-driven healthtech company specializing in prenatal ultrasound diagnostics, aiming to enhance maternal and fetal health through advanced imaging solutions.","description":"DeepEcho offers an AI-powered fetal ultrasound analysis platform that automates real-time identification of fetal ultrasound views, providing healthcare professionals with enhanced diagnostic accuracy and efficiency. Trained on one of the world's largest fetal ultrasound datasets, the platform improves the efficiency and precision of fetal ultrasound diagnostics. DeepEcho's approach is based on advanced segmentation of structures applied to fetal biometry and amniotic fluid volume assessment, enabling more detailed and standardized analysis of fetal structures supporting healthcare professionals with consistent and standardized imaging assessments. The company has received FDA 510(k) clearance for its platform, marking a significant milestone in its mission to transform prenatal care and democratize access to quality fetal ultrasound. DeepEcho is also collaborating with Butterfly Network to deploy its AI solution on Butterfly's imaging platform, aiming to improve the efficiency and accuracy of fetal ultrasound diagnostics globally.","categories":["clinical Care","diagnostic Support","patient Facing","Clinical","Diagnostic","Patient-facing"],"market_segment":["enterprise","consumer"],"target_users":["clinicians","patients","admins"],"specialties":["Obstetrics","Gynecology"],"regions_available":["United States","Europe","Africa"],"languages_supported":["English","French","Arabic"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["United States","Morocco","Europe"],"company_founding":"2020","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Automated fetal measurements","Computer-assisted ultrasound diagnosis","Teleguidance and remote diagnosis","Fast screening (3 to 5 times faster)","Precise diagnosis (over 95% accuracy)","Scalable solution (mobile and hardware agnostic)"],"optional_modules":["Advanced analytics","Clinical decision support tools","Patient management interfaces","Telehealth integration","Data visualization dashboards"],"integrations":["Epic","Cerner","Meditech","Allscripts","FHIR APIs","HL7","DICOM","Loinc","ICD-10","SNOMED CT","HL7 v2","DICOMweb","FHIR DSTU2","FHIR STU3","FHIR R4","FHIR Bulk Data API","FHIR RESTful API","FHIR SMART on FHIR","FHIR OAuth2 workflows","FHIR data normalization and transformation engines"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED CT","ICD-10","Loinc","HL7 v3","CDA","LOINC","ICD-9"],"api_available":"yes","system_requirements":["Docker","Kubernetes","AWS","Azure","Google Cloud","Linux","Windows","macOS","iOS","Android"],"compliance":["HIPAA","GDPR","HITECH","SOC 2","ISO 27001","ISO 27017","ISO 27018","PCI DSS","PIPEDA","CCPA"],"certifications":["FDA 510(k)","CE/MDR","ONC","ISO 13485","ISO 9001","ISO 14001","ISO 45001","ISO 50001","ISO 22000","ISO 27001","ISO 27017","ISO 27018","ISO 27701","ISO 31000","ISO 37001","ISO 55001","ISO 56002"],"security_features":["Encryption","RBAC","SSO/SAML","Audit logs","2FA","DLP","MFA","TLS 1.2+","AES-256","OAuth2"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization","Data residency controls","Data de-identification","Data access controls","Data retention policies","Data sharing policies","Data breach notification procedures"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2025","integration_partners":["Microsoft","Nvidia","Plug And Play","UM6P","Orange","European Bank"],"id":"SW0015","slug":"deepecho","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/deepecho.json"}}