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Woori IO, an OSR Company, Highlights FDA Clarification on Non-Medical Wearables as a Catalyst for Accelerated Commercial Launch
Woori IO, an OSR company developing next-generation noninvasive glucose monitoring technologies, today commented on the U.S. Food and Drug Administration's recent clarification regarding non-medical-grade wearable devices, noting that the FDA's position establishes a regulatory framework highly conducive to Woori IO's commercialization strategy.
About this update from Osr Holdings, Inc.
[{"type":"text","content":"BELLEVUE, Wash., Jan. 22, 2026 /PRNewswire/ -- Woori IO, an OSR company developing next-generation noninvasive glucose monitoring technologies, today commented on the U.S. Food and Drug Administration's recent clarification regarding non-medical-grade wearable devices, noting that the FDA's position establishes a regulatory framework highly conducive to Woori IO's commercialization strategy.","length":406,"tagName":"p"},{"type":"image","alt":"OSR Holdings logo (PRNewsfoto/OSR Holdings)","displaySize":"","headline":null,"caption":"OSR Holdings logo (PRNewsfoto/OSR Holdings)","className":"","disableSlideshowImg":false,"size":{"original":{"width":334,"height":277,"url":"https://media.zenfs.com/en/prnewswire.com/d1cf26310f8a0d3a1f4f003318d5e702"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/cTh6l6BCVhUkYFTe3KonaA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTY0MDtoPTUzMTtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/d1cf26310f8a0d3a1f4f003318d5e702","width":334,"height":277}},"href":"https://mma.prnewswire.com/media/2393302/OSR_Holdings_logo_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"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.","length":531,"tagName":"p"},{"type":"text","content":"Phased Commercial Strategy Aligned with Global Platform Partnerships","length":68,"tagName":"p"},{"type":"text","content":"Woori IO is pursuing a two-phase commercialization strategy designed to balance speed, regulatory discipline, and long-term clinical ambition:","length":142,"tagName":"p"},{"type":"text","content":"Phase 1: Consumer-Grade Wellness Wearables","length":42,"tagName":"p"},{"type":"text","content":"Products and software features intended to provide noninvasive, glucose-related insights for lifestyle, nutrition, and activity management. These offerings are positioned as general wellness tools and are not intended for diagnos...