{"product_name":"AVA","company_name":"See-Mode Technologies","product_url":"https://www.see-mode.com/ava","company_url":"https://www.see-mode.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0496","summary":"AVA is an AI-powered software developed by See-Mode Technologies that automates the analysis and reporting of vascular ultrasound scans, enhancing diagnostic efficiency and accuracy for clinicians.","description":"AVA utilizes deep learning, text recognition, and signal processing technologies to assist clinicians in interpreting and reporting vascular ultrasound studies. With a single click, AVA can analyze a full vascular ultrasound scan in less than a minute, significantly reducing the time taken to generate reports and minimizing manual errors. This automation augments the clinical workflow, leading to improved productivity, accuracy, and patient outcomes. AVA has received regulatory approvals, including FDA 510(k) clearance, CE Mark, and Australian TGA approval, and is commercially available in Singapore, with ongoing pilots in leading hospitals in Singapore and Australia. The product is also pending CE approval in Europe and has been approved by Singapore's Health Sciences Authority as a Class B medical device. See-Mode Technologies is continuously expanding AVA's capabilities to new clinical use cases and is conducting clinical studies with major stroke centers and research institutes worldwide.","categories":["clinical Care","diagnostic Support","administrative Operations","Clinical","Diagnostic","Administrative"],"market_segment":["enterprise","smb"],"target_users":["clinicians","radiologists","sonographers"],"specialties":["Vascular Imaging","Neurology","Cardiology"],"regions_available":["Singapore","Australia","United States","Europe","New Zealand"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["Singapore","Australia"],"company_founding":"2017","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Automated analysis and reporting of vascular ultrasound scans","Deep learning and signal processing technologies","Single-click full scan analysis in under a minute","Minimization of manual drawing requirements","Enhanced clinical workflow productivity","Improved accuracy and patient outcomes"],"optional_modules":["Advanced reporting capabilities","Integration with hospital information systems","Real-time data analytics","Customizable user interface","Multi-language support","Cloud storage integration","Patient data management","Clinical decision support tools","Regulatory compliance tracking","Audit trail generation"],"integrations":["Epic","Cerner","PACS","Billing systems","Hospital information systems","Laboratory information systems","Electronic health records (EHR)","Picture archiving and communication systems (PACS)","Radiology information systems (RIS)","Clinical decision support systems (CDSS)","Laboratory information management systems (LIMS)","Patient management systems","Medical imaging devices","Ultrasound machines","CT scanners","MRI machines","Health information exchanges (HIE)","Telemedicine platforms","Patient portals","Clinical trial management systems (CTMS)"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED CT","ICD-10","LOINC","CPT","ICD-9","HL7 CDA","HL7 CCD"],"api_available":"yes","system_requirements":["Windows Server 2016 or later","Linux (Ubuntu 18.04 or later)","macOS Mojave or later","2 GB RAM","500 MB free disk space","1 GHz processor","Internet connection for cloud features"],"compliance":["HIPAA","GDPR","HITECH","SOC 2","ISO 27001","FDA 510(k)","CE/MDR","ONC","ISO 13485","ISO 14971","IEC 62304","IEC 62366","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8","IEC 60601-1-11","IEC 60601-1-12","IEC 60601-1-15","IEC 60601-1-16"],"certifications":["FDA 510(k)","CE/MDR","ONC","ISO 13485","ISO 14971","IEC 62304","IEC 62366","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8","IEC 60601-1-11","IEC 60601-1-12","IEC 60601-1-15","IEC 60601-1-16","ISO 27001","SOC 2","HIPAA","GDPR","HITECH"],"security_features":["Encryption","RBAC","SSO/SAML","Audit logs","2FA","DLP","Data anonymization","Access controls","Regular security audits","Penetration testing"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization","Data residency options","Data access controls","Data retention policies","Data sharing policies","Data breach notification procedures","Data subject rights management"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0496","slug":"ava","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/ava.json"}}