Core Points - The company received a warning letter from the FDA on October 2, 2025, regarding non-compliance with medical device quality system regulations during an inspection conducted from June 9 to June 12, 2025 [1] - The company generated sales revenue of 114 million yuan from the U.S. market in 2024, accounting for 23.84% of total revenue, and 41.89 million yuan in the first half of 2025, representing 19.26% of total revenue [1] - The company plans to respond to the FDA's concerns and implement corrective measures to resolve the issues raised [1] Company Background - The company operates in the medical device industry, focusing on the research, development, production, and sales of medical diagnostic and monitoring equipment [3] - In July 2024, the company faced regulatory scrutiny when its infusion pump was found to be non-compliant during a quality inspection, leading to the confiscation of three defective units and a fine of 30,000 yuan [3] - The company's 2024 annual report inaccurately stated that there were no penalties or corrective actions during the reporting period, despite the regulatory action taken against it [3] Financial Performance - The company's 2024 annual report indicated a revenue of 480 million yuan, a year-on-year decline of 35.8%, and a net loss attributable to shareholders of 77.9 million yuan, a decline of 147.0% [3] - In contrast, the company's 2025 semi-annual report showed a revenue of 218 million yuan, an increase of 2.7%, and a net profit of 16.94 million yuan, a rise of 107.4% [4] - The company achieved a turnaround in its non-recurring net profit, reporting 12.45 million yuan in the first half of 2025, compared to a loss of 3.85 million yuan in the same period of the previous year [4]