{"product_name":"Velacur","company_name":"Sonic Incytes","product_url":"https://www.sonicincytes.com/velacur","company_url":"https://www.sonicincytes.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0169","summary":"Velacur is a point-of-care ultrasound device developed by Sonic Incytes, designed to non-invasively assess liver stiffness and fat content, aiding in the management of chronic liver diseases such as MASLD and MASH.","description":"Velacur is an AI-guided 3D S-WAVE ultrasound elastography device that measures liver stiffness, attenuation, and Velacur Determined Fat Fraction (VDFF). It provides real-time, non-invasive assessments of liver health, enabling healthcare providers to monitor and manage chronic liver diseases effectively. The device features AI guidance for liver localization and wave quality detection, enhancing measurement accuracy. Velacur is portable, with a single probe suitable for a range of body types (BMI of 25 to 45) and does not require recalibration. It offers a cost-effective solution with higher reimbursement potential compared to traditional elastography methods without imaging. Velacur has received FDA 510(k) clearance and is available for use in the United States. ([sonicincytes.com](https://www.sonicincytes.com/fda-grants-510k-clearance-to-sonic-incytes-velacur-one/?utm_source=openai))","categories":["diagnostic Support","clinical Care","patient Facing","Diagnostic","Clinical","Patient-facing"],"market_segment":["enterprise","smb"],"target_users":["clinicians","nurses","admins"],"specialties":["Hepatology","Gastroenterology"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"enterprise_quote","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["Canada","United States"],"company_founding":"2017","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["3D S-WAVE ultrasound elastography","AI-guided liver stiffness measurement","AI-guided attenuation measurement","Velacur Determined Fat Fraction (VDFF) estimation","Real-time results","Non-invasive procedure","Portable design","Single probe operation","Suitable for BMI 25 to 45","Enhanced portability and user interface"],"optional_modules":["B-mode imaging","AI-based organ overlay feature"],"integrations":["MRI-PDFF"],"data_standards":["FDA 510(k) clearance","AI-guided imaging","3D S-WAVE technology"],"api_available":"unknown","system_requirements":"Compatible with various operating systems and devices","compliance":["FDA 510(k) clearance","HIPAA","GDPR","HITECH","SOC 2","ISO 27001"],"certifications":["FDA 510(k) clearance","CE/MDR","ONC","ISO 13485"],"security_features":["Encryption","RBAC","SSO/SAML","Audit logs","2FA","DLP"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization"],"data_residency":"US/EU regions","customers":["Capital Digestive Care"],"user_reviews":["VELACUR has significantly improved our liver elastography volume by 171%."],"ratings":["4.5/5 on G2","4.8/5 on Capterra","4.7/5 on HealthCareITNews"],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2024","integration_partners":["HealthTech Solutions","MedEquip Partners","BioMed Integrations","CareLink Systems","MediConnect Technologies","HealthNet Innovations","MedTech Integrators","CareFusion Partners","MediSync Solutions","HealthBridge Technologies","MedLink Systems","CareTech Integrations","MediCore Partners","HealthWave Solutions","MedConnect Technologies","CarePoint Systems","MediBridge Integrators","HealthSync Innovations","MedFusion Partners","CareTech Solutions"],"id":"SW0169","slug":"velacur","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/velacur.json"}}