{"product_name":"Sonio Suspect","company_name":"Sonio","product_url":"https://www.sonio.com","company_url":"https://www.sonio.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0090","summary":"Sonio Suspect is an AI-powered software that enhances prenatal ultrasound diagnostics by improving the detection of fetal anomalies, enabling earlier and more accurate identification of abnormalities.","description":"Sonio Suspect is a cloud-based AI software designed to assist clinicians during or after fetal ultrasound examinations by automatically detecting and characterizing abnormal fetal findings. It aims to improve diagnostic accuracy and support better patient management decisions. The software underwent extensive verification and testing, demonstrating a sensitivity of 93.2% and specificity of 90.8% in detecting fetal anomalies. A multicenter reader performance study involving 47 sites, including 37 in the USA, showed a statistically significant 22-point improvement in anomaly detection (from 69% to 91% AUC, p<0.001). This improvement was consistent across diverse patient demographics and clinician backgrounds. Sonio Suspect enables early identification of subtle congenital malformations from as early as 11 weeks, providing a broader diagnostic window for early intervention and improved maternal and fetal outcomes. The software is integrated into Sonio's comprehensive reporting and workflow solution, which includes Sonio Detect, a quality assurance algorithm that ensures high-quality image acquisition. By combining real-time quality control with AI-driven anomaly detection, Sonio Suspect bridges the gap between technology and clinical application, empowering providers with consistent, efficient, and accurate prenatal screening across diverse healthcare settings.","categories":["clinical Care","diagnostic Support","patient Facing","ai Clinical Documentation Integrity","clinical Decision Support","imaging Software","reproductive Health","healthcare It","healthcare Software Solutions","healthcare Technology","Clinical","Diagnostic","Patient-facing","Artificial Intelligence","Medical Imaging","Prenatal Care","Ultrasound Imaging","Healthcare It","Medical Software","Healthtech"],"market_segment":["Enterprise","SMB","Consumer"],"target_users":["Clinicians","Obstetricians","Gynecologists","Radiologists","Sonographers","Maternal-Fetal Medicine Specialists","Healthcare Providers","Medical Institutions","Hospitals","Medical Clinics"],"specialties":["Obstetrics","Gynecology","Maternal-fetal Medicine","Radiology","Ultrasound Imaging","Prenatal Care","Fetal Medicine","Medical Imaging","Women's Health","Neonatology"],"regions_available":["United States","Europe","Asia","Africa","Australia","Canada","South America","Middle East","North America","Global"],"languages_supported":["English","French","Spanish","German","Italian","Portuguese","Dutch","Russian","Chinese","Japanese"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["France","United States","Germany","United Kingdom","Italy","Spain","Netherlands","Belgium","Canada","Australia"],"company_founding":"2020","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Digital Workplace","Hybrid Cloud","Data Management","Consulting","Managed Services","Professional Services","Support Services","Workplace as a Service","Managed On-Premises","Managed Hyperscaler","Sonio Cloud","Managed Monitoring","Managed Backup","Managed Antivirus","Managed LAN Service","Managed WLAN Service","Active Line","Advanced Line","IT Expertise on Demand","Rollout Services"],"optional_modules":["Health Check","IT Assessments","CISO as a Service"],"integrations":["Microsoft 365","VMware ESXi","HPE ProLiant DL160 G10","Veeam Backup & Replication","FortiGate Firewall","Windows Active Directory","Windows 11","Windows Server 2022","Microsoft SQL Server 2022","Dell EMC","Cohesity","Pure Storage","NetApp","TeamViewer","HP Hardware","Huawei","Veritas"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED","ICD-10"],"api_available":"unknown","system_requirements":"Windows Server 2022, VMware ESXi 8.0, HPE ProLiant DL160 G10, Veeam Backup & Replication, FortiGate Firewall, Windows Active Directory, Windows 11, Microsoft SQL Server 2022","compliance":["HIPAA","GDPR","HITECH","SOC 2","ISO 27001"],"certifications":["FDA 510(k)","CE/MDR","ONC","ISO 27001"],"security_features":["Encryption","RBAC","SSO/SAML","Audit Logs","2FA","DLP","Firewall","Intrusion Detection System (IDS)","Intrusion Prevention System (IPS)","Security Operation Center (SOC)"],"privacy_features":["BAA available","Consent Management","Anonymization","Data Minimization","Data Residency in Switzerland","Data Residency in EU","Data Residency in US","Data Residency in BYO cloud region","Data Residency in multiple regions","Data Residency in specific regions"],"data_residency":"Switzerland, EU, US, BYO cloud region, multiple regions, specific regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0090","slug":"sonio-suspect","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/sonio-suspect.json"}}