The FDA has clarified that consumer wearable products providing non-medical, wellness-oriented health insights—when appropriately labeled and marketed—generally fall outside the scope of medical device pre-market review. Woori IO believes this regulatory clarity enables the Company to meaningfully accelerate time-to-market by first launching consumer-grade, lifestyle-management wearable solutions, while continuing its longer-term development roadmap toward medical-grade noninvasive continuous glucose monitoring (CGM) systems.

This approach aligns with Woori IO’s previously announced collaboration initiatives involving Samsung Electronics–related smartwatch platforms, where early integration as a consumer wellness feature provides a scalable entry point to market while longer-term medical validation proceeds in parallel.