{"product_name":"Bladder AI","company_name":"Exo","product_url":"https://www.exohealth.com/bladder-ai","company_url":"https://www.exohealth.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0340","summary":"Bladder AI is an FDA-cleared software by Exo that utilizes artificial intelligence to accurately measure bladder volume from ultrasound images, enhancing diagnostic efficiency and patient care.","description":"Bladder AI is a medical imaging software developed by Exo, designed to assist healthcare providers in non-invasively assessing bladder volume through ultrasound imaging. It employs machine learning algorithms to analyze ultrasound images, providing rapid and precise bladder volume measurements. This tool is particularly beneficial for monitoring urinary retention and evaluating bladder function in patients with neurogenic bladder or urinary tract obstructions. Integrated into Exo's handheld ultrasound device, Exo Iris™, Bladder AI offers a portable and cost-effective solution for point-of-care diagnostics, enabling immediate clinical decisions without the need for traditional, more invasive procedures. The software has been validated through extensive clinical studies, demonstrating high accuracy and reliability in diverse patient populations and settings. Its user-friendly interface and seamless integration with Exo's ultrasound hardware make it a valuable asset in both acute and chronic care environments, improving patient outcomes and streamlining clinical workflows.","categories":["clinical Care","diagnostic Support","patient Facing","imaging Software","ai Clinical Documentation Integrity","clinical Decision Support","Clinical","Diagnostic","Patient-facing","Medical Imaging","Artificial Intelligence"],"market_segment":["Enterprise","SMB","Consumer"],"target_users":["Clinicians","Nurses","Patients","Admins","Payers"],"specialties":["Urology","Emergency Medicine","Nephrology","Geriatrics","Pediatrics"],"regions_available":["United States","Canada","Europe","Asia","Australia"],"languages_supported":["English","Spanish","French","German","Chinese","Japanese","Korean","Portuguese","Italian","Russian"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United States","Canada","Germany","China","India","Australia","United Kingdom","France","Japan","South Korea"],"company_founding":"2019","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["AI-powered ultrasound imaging","FDA-cleared diagnostic tools","Bladder volume measurement","Cardiac ejection fraction estimation","Lung condition assessment","IVC collapsibility analysis","Hip dysplasia detection","Thyroid nodule evaluation","Automated image quality assessment","Real-time feedback during scanning","Educational resources for clinicians","Modality worklist integration","Automated report generation","Customizable exam worksheets","Mobile-enabled documentation workflows","Integrated billing with CPT codes","Quality assurance and proficiency tracking","User management and setup","Cloud-based storage with unlimited capacity","Data redundancy and backup"],"optional_modules":["Exo Works Connect","Exo Works Enterprise","Exo U education platform"],"integrations":["DICOM-enabled POCUS devices","PACS systems","VNA systems","EHR systems supporting HL7 protocol"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"yes","system_requirements":"AWS cloud infrastructure","compliance":["HIPAA","SOC 2 TYPE II","ISO 27001","ISO 27701","GDPR","HITRUST certified"],"certifications":["FDA 510(k) clearance for medical devices"],"security_features":["AES 256-bit encryption","Role-based access control (RBAC)","Single Sign-On (SSO) with SAML","Audit logs","2FA"],"privacy_features":["BAA available","Data minimization","Anonymization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0340","slug":"bladder-ai","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/bladder-ai.json"}}