Core Viewpoint - 康泰医学 faces regulatory scrutiny from the FDA regarding compliance with medical device quality system regulations, which may impact its operations in the U.S. market [1][3] Group 1: Regulatory Issues - 康泰医学 received a warning from the FDA regarding non-compliance with 21 CFR Part 820 regulations during an inspection scheduled for June 2025 [1] - The FDA has indicated that it will refuse the company's products entry into the U.S. until the identified issues are resolved [1][3] - The company plans to submit a response report to the FDA within the stipulated time to address the concerns raised [3] Group 2: Financial Performance - In 2024, 康泰医学 reported U.S. sales revenue of 114 million yuan, accounting for 23.84% of total revenue, and in the first half of 2025, revenue was 41.89 million yuan, making up 19.26% of total revenue [1] - The company experienced a significant decline in performance post-COVID-19, with 2024 marking its first loss since going public, reporting revenues of 480 million yuan and a net loss of 77.9 million yuan [5][7] - However, in the first half of 2025, 康泰医学 saw a recovery with revenues of 218 million yuan and a net profit of 16.94 million yuan, reflecting a year-on-year growth of 2.72% and 107.39% respectively [7] Group 3: Market Strategy - 康泰医学 has been expanding its market presence, having sold products to over 140 countries and regions, and holds 24 FDA medical device registrations [3] - The company is adjusting its global market strategy due to fluctuating U.S. tariff policies, increasing costs for customers, and is focusing on expanding into Africa, Europe, Southeast Asia, and South America [7]