| Summary |
CardioMirror: world's only dual FDA-cleared rPPG (K223622 HR; K243966 RR). 40-second scan: HF screening AUC 0.90, 89.71% accuracy (Journal of Cardiology 2025, n=68) and world-first NT-proBNP biochemical prediction (AUC 0.90, n=246, R2->0.743). Multi-site validated: Taipei Veterans, Pingtung rural care, Chang Gung (NDA). Azure FHIR, HIPAA/GDPR. SNQ, NHQA, National Innovation Award, Forbes Asia 100. TRL 7. |
| Scientific Breakthrough |
World's only dual FDA-cleared rPPG (K223622/K243966), outperforming Philips (+-2 vs +-3 bpm) across 10 disease groups. World-first FDA-validated rPPG predicting NT-proBNP elevation (AUC 0.90, n=246, R2->0.743)—from physiological monitoring to biochemical prediction. HF AI screening AUC 0.90, 89.71% accuracy (Journal of Cardiology 2025, n=68, 5 devices). Five-module multimodal platform: HR, RR, AF, HF, NT-proBNP. TRL 7, SNQ, NHQA, Forbes Asia 100. |
| Industrial Applicability |
Multi-site validated: Taipei Veterans (300 AF/HF enrolled), Pingtung veterans home rural validation complete, Chang Gung Hospital NDA signed for TFDA clinical pathway. Azure FHIR B2B platform for enterprise health management and insurtech underwriting. TFDA clearance targeted FY116. International expansion to the worldwide via dual FDA clearances through Microsoft Azure partner ecosystem, addressing aging-society cardiovascular screening gaps at scale. |