{"product_name":"InVision Precision Cardiac Amyloid","company_name":"InVision Medical Technology Corporation","product_url":"https://invisionmedical.com","company_url":"https://invisionmedical.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0016","summary":"InVision Precision Cardiac Amyloid is an AI-driven software that analyzes echocardiograms to detect cardiac amyloidosis, aiming to improve early diagnosis and patient outcomes.","description":"InVision Precision Cardiac Amyloid is a Software as a Medical Device (SaMD) developed by InVision Medical Technology Corporation. It utilizes machine learning algorithms to analyze transthoracic echocardiogram videos, specifically apical-4-chamber and parasternal-long-axis views, to identify signs of cardiac amyloidosis in patients aged 65 and older. The software integrates with existing hospital imaging systems, providing decision support alerts to guide clinicians in referring patients for further confirmatory tests. It received FDA 510(k) clearance on May 21, 2025, and was granted Breakthrough Device Designation by the FDA in January 2024. Additionally, the American Medical Association adopted a new Category III CPT code (0932T) for this technology, effective January 1, 2025.","categories":["diagnostic Support","clinical Care","cardiology","Diagnostic","Clinical","Cardiology"],"market_segment":["enterprise","consumer"],"target_users":["clinicians","patients"],"specialties":["Cardiology"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["United States"],"company_founding":"2020","deployment_model":["SaaS"],"os_platforms":["Web"],"features":["AI-powered detection of cardiac amyloidosis","Automated analysis of transthoracic echocardiogram videos","Integration with existing hospital imaging systems","Decision support alerts for clinicians","FDA 510(k) clearance","FDA Breakthrough Device Designation","Published in JAMA Cardiology","CPT code 0932T for billing","Collaboration with Alexion to improve detection","Clinical validation on 1,221 echocardiogram studies","Sensitivity of 60.7% and specificity of 99.0%","Compatible with DICOM imaging standards","Supports adult patients aged 65 and over","Intended for use by interpreting physicians","Operates on hosted platforms","Complies with IEC 62304 software standards","Complies with ISO 14971 risk management","Cybersecurity testing confirmed no vulnerabilities","No physical form; installed as a third-party application","Assists in diagnosis of cardiac amyloidosis"],"optional_modules":[],"integrations":["PACS systems"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"Compatible with DICOM-compliant imaging devices and PACS systems","compliance":["FDA 510(k) clearance","FDA Breakthrough Device Designation","IEC 62304","ISO 14971","HIPAA","SOC 2","ISO 27001"],"certifications":["FDA 510(k) clearance","FDA Breakthrough Device Designation","CPT code 0932T","IEC 62304","ISO 14971","ISO 27001"],"security_features":["Cybersecurity testing confirmed no vulnerabilities"],"privacy_features":["Complies with HIPAA","Complies with ISO 27001"],"data_residency":"Hosted platforms","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0016","slug":"invision-precision-cardiac-amyloid","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/invision-precision-cardiac-amyloid.json"}}