"AI-Powered Hemodialysis Auxiliary Monitoring Software" — world＇s first Hemodialysis SaMD integrating Explainable AI (SHAP) with HL7 FHIR R4 standards. Three modules — heart failure (AUC 0.95, 2-4hr early warning), intradialytic hypotension, and hemoglobin/EPO precision dosing — provide transparent vendor-neutral clinical decision support. Multi-center IRB-approved prospective trial completed; technology transferred to Musheng Technology; TFDA Class II certification targeted for Q3 2026.

World＇s first Hemodialysis platform integrating Explainable AI (SHAP) with HL7 FHIR R4 open architecture. Heart failure AUC 0.95 with 2-4 hour lead time — 300-400% gain over international benchmarks (15-75 min). Three-module integration (heart failure, IDH, HGB/EPO) breaks the single-target paradigm of Fresenius and Dosis. Cross-vendor FHIR R4 dissolves closed-system barriers. IRB-approved prospective multi-center trial (50 patients) under way; TFDA Class II SaMD submission in progress.

Addresses 366 dialysis centers and 96,000 patients in Taiwan, saving NT$6 B in annual healthcare costs. Technology transferred to Musheng Technology (Dec 2024) for SaaS commercialization at NT$10,000/bed/month with edge hardware bundles. TFDA Class II SaMD certification targeted Q3 2026—Taiwan＇s first dialysis AI SaMD license; US FDA 510(k) and CE-MDR pathways by 2028. 2030 revenue target NT$3 B; Musheng IPO positioned as global leader in Explainable Hemodialysis AI.