Recently, home medical device leader Yuyue Medical (002223. SZ) announced that its non-invasive ventilator has obtained FDA approval and is suitable for the treatment of adult patients with obstructive sleep apnea.

Just before that, Yuyue Medical had just submitted a quarterly report on its probation. In the third quarter of 2026, the company's revenue was 2.042 billion yuan, a year-on-year increase of 8.28%; The net profit attributable to the parent company was 288 million yuan, a year-on-year increase of 9.55%.

The growth rates of 8% and 9% in a single season are not impressive compared to the historical growth rate of Fish Leap. But before that, this leading medical device manufacturer has been under pressure for several consecutive quarters. In the first half of the year, the company's revenue was 4.569 billion yuan, a slight decrease of 1.92% year-on-year; The net profit attributable to the parent company was 843 million yuan, a year-on-year decrease of 29.92%.

The turning point appeared in the third quarter. The respiratory therapy sector has resumed year-on-year growth, with continuous blood glucose monitoring (CGM) and emergency services continuing to increase in volume. The proportion of overseas revenue has been rising quarter by quarter, and there is a clear signal of improvement in operating margins. The "globalization, digitization, and wearability" strategy of Yuyue Medical is moving from planning to implementation.

New Market

OSA， Obstructive sleep apnea, also known as obstructive sleep apnea, is a disease that has been underestimated for a long time. Patients repeatedly experience respiratory pauses during sleep, which not only leads to extreme drowsiness and difficulty concentrating in daily life, but may also cause serious damage to the heart, brain, metabolic system, and other organs in the long run.

Non invasive ventilators are the first-line standard treatment for obstructive sleep apnea, and the United States, with its large patient base, mature sleep diagnosis and treatment system, and commercial insurance payment ability, is the world's largest single market for non-invasive ventilators.

Yuyue Medical had a business layout in the United States before, but the core category of ventilators has always lacked an admission qualification certificate.

BreathCare PAP III has obtained FDA approval, which means that Yuyue's non-invasive ventilator has obtained its first pass for sale in the United States. This not only adds a key link to Yuyue's respiratory therapy product matrix in the United States, but also qualifies it to be sold in combination with existing sleep breathing masks and enter the OSA treatment scene.

This is an important breakthrough in the certification of the company's ventilator products in the US market, "Yuyue Medical said in the announcement. Respiratory therapy solutions are listed as a key development area under its globalization strategy, and the US market is an indispensable stop in this strategy.

The earlier groundwork occurred on the channel side. Yuyue Medical has partnered with Inogen, a US listed company, to promote respiratory therapy products to the US market through Inogen's channels, while also strengthening supply chain cooperation. Inogen has a mature distribution network for home respiratory therapy in the United States, with Yuyue providing products and Inogen providing entry points.

At present, the company's business scale in the US market is in its infancy, with relatively fast growth rate, "Yuyue Medical said in a recent investor exchange. The initial stage means a small base, but also means a large space.

Obtaining an FDA certificate is not an isolated action. The positioning of Yuyue Medical's overseas business is: "In the future, the export business will continue to release development momentum and become one of the important engines for the company's development

In the first half of 2026, Yuyue Medical's export revenue was 824 million yuan, a year-on-year increase of 35.76%, accounting for 18.03% of the total revenue. In the third quarter report, the company confirmed that the proportion of export revenue to total revenue has been increasing quarter by quarter.

Behind the growth rate is a structural change. The business in Europe and America continues to break through, while traditional advantageous regions such as Southeast Asia and South America maintain steady growth. Yuyue Medical has completed its subsidiary layout in multiple countries, gradually equipping localized marketing, registration, and user service teams. The main structure of the respiratory therapy team has been established, and the localization structure of other departments is being promoted.

The registration pace on the product side is also accelerating. The Anytime4 and Anytime5 series of continuous blood glucose monitoring products obtained EU certification in early 2026, and their overseas sales layout is gradually expanding. AED products in the emergency department have obtained registration certificates in multiple domestic and international locations, and the penetration of the Pumeikang brand in overseas channels is deepening.

New Product

If oxygen concentrators and ventilators are like fish leaping now, wearing and metabolic management point to another possibility.

Since 2026, Yuyue Medical has launched the Smart Health Ring R3 and the Smart Blood Pressure Watch A1. Both products are not isolated new products, they each carry the genes of Yuyue's original business: R3 is implanted with algorithm capabilities accumulated in the field of sleep ventilators, and Watch A1 integrates core measurement technology of blood pressure monitors for nearly 20 years. Its blood pressure monitoring function has obtained the "Medical Device Registration Certificate" in July 2026.

The answer to how to interpret data collected through smart wearable hardware is AI. In the future, we plan to promote the development of AI applications related to wearable products, metabolic management products, etc., collect and manage health data, and provide personalized health education, indicator interpretation, and lifestyle recommendations for users based on clinical guidelines. ”

In addition to interpreting sleep and blood pressure data, AI is also applied in the metabolic management system of Fish Leap. The 'Annai Sugar' application is an AI intelligent platform for fish leaping metabolism management, and also the core gateway connecting users and hardware. In the investor exchange in August, Yuyue Medical introduced its metabolic management architecture as follows: starting from continuous blood glucose monitoring, gradually expanding to multiple monitoring dimensions such as blood glucose, uric acid, and lactate, and building an ecosystem based on biosensors and wearable devices.

Continuous blood glucose monitoring is rapidly emerging at a speed far exceeding the overall market, and dynamic blood glucose meters have become the choice of many middle-aged and young people. It can continuously monitor glucose concentration 24 hours a day, which not only helps to adjust medication more accurately to improve blood sugar levels, but also has significant advantages in comfort and convenience compared to traditional fingertip blood glucose meters.

Yuyue Medical is a leading enterprise in the field of continuous blood glucose monitoring. In the first half of 2026, its business revenue will more than double, and its market share will rank among the top in the market. The AnNai Tang APP will also be among the top downloads of similar applications for a long time.

For the future key research and development areas, in addition to metabolic management, respiratory therapy remains the focus of Yuyue Medical. In this mature sector, Yuyue hopes to deeply explore the value of its existing channels and user base.

Yuyue's existing sleep ventilators are capable of learning user breathing patterns and automatically adjusting parameters. The next generation of intelligent ventilators will be equipped with AI agents, which will stack intelligent treatment support capabilities on top of the existing product matrix.

The treatment of OSA requires patients to have good compliance. Whether patients can persist in wearing it and whether the parameters can keep up with the changes in airway status every night will affect the treatment effect. AI solves the problem of 'persistence' by making machines adapt to humans, rather than making humans adapt to machines.

Whether it's smart rings, blood pressure watches, dynamic blood glucose meters, or smart ventilators, what Yuyue is doing is making the body readable. How to breathe at night, how blood pressure fluctuates during the day, how blood sugar fluctuates after eating - fragments scattered in hospital reports and vague sensations in the past can all be collected together and translated into language that humans can understand by AI. For Yuyue, selling a machine is no longer the end of the business, but the starting point for the flow of data and the cultivation of user inertia.