HF Post-Discharge
Prescription
→
Daily Voice
Monitoring
→
Early Detection
of Worsening
→
Early Intervention
(Outpatient)
Approval
- Confirmatory clinical trial with MFDS (8 sites, ~150 patients) from H2 2026
- Market entry via innovative medical device integrated review (Q1 2027)
Distribution
- Partnership with pharma & diagnostics companies (~Q3 2026)
U.S.
- RPM based Digital Medical Device for U.S. Market Entry ('27~'28)