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Why did Huawei choose the most fiercely competitive track for its first Class III medical device?

动脉网2026-11-03 09:16
Huawei has obtained the CGM Class III Medical Device Registration Certificate and entered the fiercely competitive CGM market.

A medical device whose selling price has dropped to around 100 yuan and requires users to continuously purchase consumables has welcomed a heavyweight participant.

On October 30, Huawei's Continuous Glucose Monitoring System (CGM) was approved by the National Medical Products Administration. This is Huawei's first Class III medical device to obtain approval, which also means that Huawei has officially entered the CGM market.

In the past few years, Huawei has continued to make layouts in the fields of smart wearables and health monitoring, and a number of hardware or software products as Class II medical devices have been approved. For the CGM market that has formed a certain competitive pattern, what changes will Huawei's entry bring?

01

Huawei breaks into the crowded CGM market

CGM has become one of the fastest-growing segmented sectors in the medical device industry in recent years.

Different from traditional fingertip blood glucose meters, CGM monitors glucose in interstitial fluid through sensors, which can realize continuous blood glucose tracking, show the trend of blood glucose changes, and give early warning of high and low blood glucose risks. It can provide more complete blood glucose data for diabetic patients and is easy to use in long-term blood glucose management.

Overseas brands such as Abbott and Dexcom have long maintained high market recognition. In recent years, with the continuous iteration of domestic product technology, the advantage of cost performance has gradually become prominent, and the domestic CGM industry has achieved rapid development.

According to public information from the National Medical Products Administration, more than 30 CGM products have been approved for marketing in China so far.

Among them, local enterprises such as Sinocare, Medtrum, MicroTech Medical, and Yuwell Medical have established relatively mature product systems, sales channels and user bases.

The industry growth is directly reflected in the revenue of enterprises, and CGM has become the core growth business of many medical device companies. Taking MicroTech Medical, which separately disclosed its CGM performance, as an example: its CGM revenue exceeded 400 million yuan in 2025, and the growth momentum continued in 2026, with the revenue of the first half of the year alone exceeding 300 million yuan, a year-on-year increase of 118.7%.

As the market continues to expand, the market competition of CGM is also becoming increasingly fierce.

Data from e-commerce platforms shows that when users buy multiple boxes of products at one time, the unit price of CGM can be as low as around 100 yuan. Compared with the price of hundreds of yuan when CGM just started in 2021, the price has dropped significantly. Some enterprises have begun to build AI+CGM continuous services and integrate blood glucose monitoring with other monitoring functions to enhance product competitiveness.

It is not difficult to see that the market environment when Huawei launches CGM this time is completely different from that when it launched the last physical medical device, namely the wrist dynamic blood pressure recorder.

In 2024, Huawei launched the wrist dynamic blood pressure recorder. Although there were many manufacturers in the traditional dynamic blood pressure market, Huawei integrated the monitoring function into smart watches to form a new product form and expanded the usage scenarios. The carrier of this medical device, the smart watch, is essentially a consumer electronic product, and blood pressure monitoring is one of the auxiliary functions.

CGM is different. As an independent medical device not integrated into other devices, it has stronger medical attributes. At the same time, competitors already have mature products with extremely similar functions, and have established stable channels and user groups. Although the industry still has room for growth, there is little room for significant differentiated advantages in the short term.

02

No obvious advantages yet, how to open up the market?

In September 2026, He Gang, CEO of Huawei Terminal BG, publicly stated that Huawei has carried out four years of technical research in the field of blood glucose testing equipment and has come up with an industrializable technical solution, which means that Huawei has made technical preparations for a long time.

According to the laws of the industry, consumer electronics enterprises that deploy Class III active medical devices rarely build a biosensor production line from scratch. A more possible division of labor is that Huawei takes the lead in core algorithms, system design, brands, channels and ecology, while sensor manufacturing or key membrane materials are handed over to professional medical device teams.

However, information about Huawei CCM's sensor technology route, core algorithms, supply chain or partners has not been made public, so it is impossible to accurately analyze how high the independent technical barriers it has established in the core links of CGM are.

In the context of no more product details being disclosed, combined with the current public registration information, the applicable scope and core functions of Huawei CGM are at a similar level to the mainstream products already on the market.

The registration information from the National Medical Products Administration shows that this approved product is oriented to adult diabetic patients over 18 years old, and is used for continuous or regular monitoring of interstitial fluid glucose levels. The device can provide and store real-time blood glucose values for users to track the trend of blood glucose concentration changes. When the blood glucose level is lower or higher than the preset value, the product can send a reminder. The product is for single user use only, no user calibration is required, and the maximum usage time is 16 days.

Continuous monitoring, blood glucose trend reminder and other functions are the standard configurations of CGM. Compared with the 14-day service life of mainstream domestic products, Huawei's 16-day "battery life" is only a small improvement, which alone is not enough to build significant product competitiveness.

From the applicable population, monitoring functions to clinical positioning, the existing public information is not enough to show that Huawei CGM has significant advantages or technical highlights compared with its competitors.

In this context, where may the competitiveness of Huawei CGM come from?

The first is brand and channels.

Huawei has accumulated a huge user base in the fields of smartphones, smart watches and sports health, and its brand has high recognition on the consumer side. Relying on existing mobile terminals, Huawei Mall, offline stores and the Sports Health App, Huawei can efficiently reach potential target groups.

Another obvious competitiveness comes from the health data ecology.

For other CGM and health monitoring products, the status quo of data fragmentation has existed for a long time. Even for CGM products of the same manufacturer, different series may require users to switch between different apps, and cross-brand and cross-type health monitoring data are even more scattered.

Huawei smart terminals can previously integrate multiple health data such as dynamic blood pressure, electrocardiogram, and sleep. They can not only connect the data collected by Huawei's own products, but also support the import of data from some third-party devices, including data from third-party CGM.

After Huawei has its own CGM, it will be connected with the previous data system, so that users can view it in familiar devices and applications, lowering the usage threshold for ordinary users, and even obtain personalized health management solutions combined with comprehensive health data.

03

Selling one CGM is only the beginning of the competition

The commercial logic of medical devices is completely different from that of consumer electronics. Even among medical devices, there are significant differences between CGM and the dynamic blood pressure monitoring watches that Huawei has launched.

The special feature of CGM is that after users purchase the product for the first time, they usually have repurchase demands, either for the integrated CGM whole machine or the probe of the split CGM; in this process, a number of personalized services such as wearing operation guidance, blood glucose data interpretation, and patient popular science education are also required.

For enterprises, brand advantages can drive users to make the first purchase, but may not be able to drive users to repurchase and use continuously for a long time. The market position of CGM products is ultimately determined by multi-dimensional comprehensive strength.

Users' daily usage experience directly affects their willingness to repurchase.

The detection accuracy and data stability of the sensor, wearing comfort, effective usage time, as well as the data transmission between the device and the mobile phone and the abnormal reminder capability will directly affect the actual feeling of users.

More critically, beyond the technical parameters of the product, many seemingly trivial experience details may directly affect the user experience. In actual usage scenarios, many users will encounter various practical troubles: the adhesive patch falls off due to sweating and friction, resulting in consumable loss; long-term application causes skin itching, red rashes and allergies; the raised sensor body brings foreign body sensation, and the discomfort is further aggravated during side lying and exercise; some products have insufficient waterproof performance and need to be removed when wading for a long time, resulting in interruption of blood glucose monitoring.

In addition, the inherent problems of interstitial fluid monitoring itself, such as reading delay and occasional false alarms, may affect users' willingness to use. This requires enterprises to attach importance to users' experience in these trivial details while iterating sensor hardware and optimizing algorithms.

Good user retention is also inseparable from the support of supporting professional services. The after-sales service of CGM is not limited to hardware fault handling, but also requires professional medical staff to provide timely guidance and intervention.

The sensor wearing method, alarm parameter setting, blood glucose trend interpretation, and the response plan after abnormal values appear all need a perfect service system as support.

Specifically, this includes the evaluation and screening of applicable groups by medical staff, guiding users to wear the device in a standardized manner and rotate the wearing parts; interpreting the continuous blood glucose curve, identifying imperceptible blood glucose fluctuations, and assisting in adjusting the glucose control plan combined with monitoring data; professionally identifying alarm information, distinguishing false alarms from real high and low blood glucose risks, and giving corresponding disposal suggestions.

When the hardware monitoring capability becomes mature, industry competition will further extend to the competition for the service entrance of diabetes management.

CGM can continuously collect blood glucose data, but the original data itself will not automatically convert into clinical value. How to apply massive monitoring data to the real diabetes diagnosis and treatment process has become the key layout direction of leading enterprises.

At present, many CGM manufacturers are building data platforms for medical institutions and clinicians: connecting patients' dynamic blood glucose data with hospital information systems or Internet medical platforms to support doctors' remote viewing, condition follow-up and medication efficacy evaluation; or connecting the link of dynamic blood glucose meters, insulin pumps and other devices to realize the linkage between monitoring and treatment links, and explore to connect patients, doctors and medical service institutions based on testing equipment and digital platforms.

Therefore, the competition boundary of CGM enterprises is still expanding.

For Huawei, smart terminals, sports health platforms and a huge consumer user base can lay a foundation for CGM to reach potential users, and the health service ecology also provides space for integrating subsequent services. However, the competition of CGM is far more than the competition of terminal advantages. What are the detailed innovations of Huawei's new product? What new changes will it bring to the highly competitive CGM industry? The answer will be given after the product is officially launched.

This article is from the WeChat official account "vcbeat" (ID: vcbeat), written by Zhang Xiaoxu, and published with authorization from 36Kr.