On October 8, the Guangdong Provincial Food and Drug Administration released the “List of Approved Products for the Pilot Program of the Guangdong Medical Device Registrant System (as of 2021-10-8)”, and Huawei’s wrist single-lead ECG collector was officially approved for production. The number is: Guangdong Machinery Note 20202071705, the trustees are Goertek Co., Ltd. and Weifang Jingwei Hi-Tech Electronic Technology Co., Ltd., the approval date is September 10, 2021, and the validity period is October 22, 2025.
In addition to the single-lead ECG collector on the wrist, as early as August 23, the Guangdong Provincial Drug Administration issued the “Announcement of the Application for Priority Approval of Class II Medical Devices in Guangdong Province (Issue 49)”, showing that, Huawei also has three medical devices that have entered the priority approval process. They are wrist ECG blood pressure recorder (MLY-B10, MLY-B11), ECG analysis system (ECG-1), and arrhythmia analysis system (PPG-1).
It has already been deployed on relevant medical testing patents
As early as May 2021, He Gang, president of Huawei’s consumer business mobile phone product line, revealed that Huawei is developing wearable blood pressure measurement devices, and will launch research on hypertension management with well-known domestic institutions to explore blood pressure innovations from screening to early intervention. Active health management. Among them, the first smart watch that can measure blood pressure has passed the medical device registration inspection.
At the end of August, Goertek said in an institutional survey that in recent years, the concept of health has been used more and more on smart watches, and monitoring functions such as ECG and blood oxygen have continued to appear. In the next two or three years, there may be blood sugar, blood pressure, etc. Functional breakthrough. With breakthroughs in technology and applications, product profit models may also change, not only in hardware sales, but also in services. Goertek also has a good layout in this field, and will actively seize opportunities and serve customers well.
The Tianyancha APP shows that Huawei Terminal Co., Ltd. and Huawei Technologies Co., Ltd. have published a number of medical-related patents, such as “a heart rate detection method and device” and “heart rate detection method and system” applied for in 2016. At the same time, Huawei companies such as Patents for “An ECG Detection Device” that can reduce the difficulty of designing and manufacturing ECG detection devices, patents for “ECG Detection Device, Circuit and Method” that can improve the accuracy of ECG detection, etc. At present, Huawei Technologies Co., Ltd. has applied for over 100 trademark registrations under the international classification of “medical devices”, and 44 of them have been registered.
In February of this year, Huawei’s patent information on “device and method for electrocardiographic measurement” was authorized to be disclosed. Embodiments of the present invention relate to the technical field of medical devices, and more particularly, to a device and method for electrocardiographic measurement.
The old rivals in the mobile phone industry, the battlefield has shifted
It is worth noting that on June 25, the website of the State Drug Administration released the information to be received for medical device approval documents (import), the first of which is the mobile electrocardiogram atrial fibrillation reminder software from Apple Inc. The registration certificate number is “National Machinery Injection 20212210223”.
Source: State Drug Administration website
Huatai Securities analyzed that in recent years, in addition to the first-generation heart rate monitoring, Apple has gradually added key physiological data such as electrocardiogram and blood oxygen to the watch. This approval will help the “electrocardiogram” function to be approved in mainland China and help Apple Watch sales increase.
Huatai Securities said that since the release of the first Apple Watch in September 2014, the company has maintained the launch progress of at least one smart watch every year, except for no new products released in 2015. From the product function point of view, the feature richness of Apple Watch has been continuously improved, which has driven the continuous increase in product shipments. Data shows that Apple’s smartwatch shipments have increased from 14.7 million in 2017 to 32.04 million in 2020, making it the world’s largest smartwatch supplier.
Huawei and Apple’s wearable medical products have been approved one after another, which also shows a problem, that is, consumer electronics manufacturers have seen opportunities in medical products and have made great efforts, and obtaining medical device certification is no longer a new thing.
Taking Apple as an example, as early as 2018, its ECG APP and arrhythmia reminder function obtained FDA approval through the De Novo channel; in October 2020, it obtained FDA 510(k) Class II medical device certification; 2021 On June 21, it officially obtained the medical device registration certificate from the my country Food and Drug Administration.
Domestic companies are not behind. On September 24, 2020, OPPO announced the world premiere of OPPO Watch ECG, and announced that this smart watch with ECG continuous monitoring function has obtained the NMPA medical device class II certificate, which is the first certificate in China. Smart watch; On October 23, 2020, the wrist single-lead ECG collector applied by Huawei Terminal Co., Ltd. obtained the medical device product registration certificate. On October 30, the HUAWEI WATCH equipped with this technology was officially released, becoming Huawei’s first certified smart wearable medical device.
Huawei’s first smart wearable medical device to obtain a Class II medical device registration certificate from the State Drug Administration
Common “skills” for wearable medical products
However, although major mobile phone manufacturers have added health functions to smartwatches and are developing towards medical devices with more accurate test results, there are currently only four ECG smartwatches that have obtained the second-class medical device certificate in China, namely Huawei and OPPO. , Apple, Huami. Device House introduced some common medical terms in wearable medicine and Huawei’s layout in the medical industry, and took stock of these products.
Accurate measurement of ECG
ECG is short for electrocardiogram, which means electrocardiogram. Each time the human heart beats, the contraction and relaxation will send out corresponding electrical signals. The electrocardiogram records the electrical signals of the heart through the wires placed in various positions of the body. Due to the different electrical signal strengths of different parts of the body, the more points are usually arranged, the more accurate the measurement will be. When we do a physical examination in the hospital, doctors usually use 12 leads with 10 collection points for ECG monitoring, that is, stick electrodes on 6 points on both wrists, ankles and chest. When measuring with a Huawei watch, users only need to wear the watch correctly and touch the newly added electrode on the side of the Huawei Watch GT2 Pro ECG watch with their fingers, and the result report can be quickly generated in 30 seconds.
Many people often have ECG collection in their daily physical examinations, but it is difficult for ordinary people to understand the complex radio signals. In addition to the choice of AI algorithms to interpret ECGs, Huawei has joined forces with “National Telemedicine and Internet”. The medical center is an authoritative national-level medical center. Professional doctors from selected top three hospitals provide artificial ECG interpretation services, and give out the doctor’s signature. Report, give ECG interpretation results, help users to detect high risk of arrhythmia early, and manage heart health independently. The feedback results can be sent out within 1-2 minutes at the earliest on working days.
Huawei cooperated with 301 Hospital to launch a heart health research project. Since 2018, the innovative team of Professors Chen Yundai and Guo Yutao from the Cardiology Department of 301 Hospital has used the photoplethysmography (PPG) technology of Huawei smart wearable devices to screen for atrial fibrillation. The screened people with atrial fibrillation have supported atrial fibrillation through a multidisciplinary team. The integrated management strategy provided by the management platform (mobile Atrial Fibrillation Application, mAFA) realizes the self-management of primary and secondary prevention of atrial fibrillation management and patient participation.
Photoplethysmography (PPG) detects heart rate by detecting the amount of visible light, such as green light, reflected in human tissue. Usually there are two or three green LEDs that emit visible light to the wrist, and then there is a photoelectric sensor in the middle to receive and process the reflected light. heart rate.
Medical Grade Blood Glucose Monitoring Software
According to Huawei’s official website, after HUAWEI WATCH is connected to the minimally invasive sensor, you can view the current blood sugar in real time on the watch through medical-grade blood sugar monitoring software, and it will vibrate to remind you if there is an abnormality. Currently, it only supports the use of the Miqi blood glucose meter (device Model: RGMS-III). The blood glucose meter needs to be purchased separately by the user, and the user needs to download and configure the relevant Miqi blood glucose monitoring software on the watch. In addition, the device also supports blood oxygen saturation measurement, fall alarm, sleep monitoring, and exercise recording functions.
Not only equipment, Huawei has also deployed telemedicine
With its 5G technology advantages and huge R&D investment, Huawei will not only maintain the top shipments of smartwatches, but also take the lead in the number of medical device certifications, as well as take a lead in medical layout. At present, Huawei’s entry point into medical devices is only wearable devices, but it is difficult to speculate whether it will expand to other fields in the future. However, no one doubts Huawei’s ability to expand into other medical device fields.
Of course, Huawei’s ambitions in the medical industry go far beyond medical devices. As early as 2016, Huawei released the “White Paper on the Application Directions of Five 5G Industries”. One of them is the application of 5G in the medical industry, including remote monitoring of wearable medicine, remote surgery, remote imaging consultation, telemedicine, and asset supervision.
In March 2019, Huawei changed the company’s business scope and added businesses such as the sale of medical devices (Class II medical devices). Glory Terminal Co., Ltd., established on April 1, 2020, is also involved in the field of medical devices again, further expanding the medical field. At the end of November 2019, the business of Shensi Artificial Intelligence Robot Technology (Beijing) Co., Ltd. invested by Hubble Technology Investment Co., Ltd., a wholly-owned subsidiary of Huawei, changed its business and sold medical devices I and II, computers, software and replication equipment.
Relying on related technologies and equipment such as big data and cloud computing technology, Huawei has established cooperation with a number of large general hospitals in the field of digital hospital construction.
Smart watch as a stepping stone to enter the ECG track
OPPO Watch ECG version The OPPO Watch ECG version adopts a single-lead design, has medical-grade measurement accuracy, and has passed the National Medical Products Administration (NMPA) certification. It is very convenient to use OPPO Watch ECG version to measure ECG: in wearing state, click the “ECG” APP on the watch side, use the finger pulp of the other hand to press and hold the navigation key, keep still and wait for the 30s measurement countdown to complete to obtain the ECG data. The mobile terminal bound to the watch will also receive the synchronous push.
OPPO Watch ECG also provides two ECG analysis methods.
The AI analysis algorithm can produce a complete analysis report within 3 seconds of analysis, and can also output a full range of answers from indicator analysis to health advice. The algorithm itself is supported by the National Center for Telemedicine and Internet Medicine, and has passed more than 100 hospitals across the country. Verified by millions of users. The expert interpretation is to analyze the ECG data online by real doctors. The data submitted from 08:00 to 17:00 every day will be interpreted in about 2 hours, and the data submitted outside the working hours will be submitted at 12:00 the next day. The interpretation is completed around 00, and each interpretation will be charged according to the business level of the selected doctor.
In fact, since the Apple Watch 4, the ECG function has become standard. As early as 2018, Apple launched the ECG electrocardiogram detection function on the Apple Watch Series 4 and obtained FDA approval. However, because this function is a medical device attribute, Apple failed to pass the medical device certification of the Chinese Food and Drug Administration, so Apple Watch Series 4 did not support this function in China at first. On June 21, 2021, it officially obtained the medical device registration certificate of the my country Food and Drug Administration.
According to Apple’s official website, the currently launched Apple Watch Series 6 can monitor the heart. Once the heart rate is found to be too high or too low, the heart rate app will issue an early warning reminder. The ECG electrocardiogram function only takes 30 seconds to distinguish whether the sinus rhythm is normal, irregular or accompanied by sinus atrial fibrillation, and draws a heart rate map with detailed data in the iOS Health APP, which can be saved in PDF format .
Huami AMAZFIT Meter Health Watch
The AMAZFIT health watch adopts the high-precision bio-tracking optical sensor independently developed by Huami Technology – BioTracker? PPG sensor, which can continuously collect heart rate data at a sampling rate of 50 Hz for 24 hours. The detection interval is short, and the monitoring data is accurate. higher.
The AMAZFIT health watch is also equipped with an ECG electrocardiogram sensor. It innovatively adopts a four-sided surrounding push-type design. There are metal sheets around the watch frame. Users can measure with a more free posture, while also increasing the metal contact area. , lower impedance and make ECG signal more accurate.
In a test study conducted by Huami Technology and the Department of Cardiovascular Medicine of Peking University First Hospital on 290 cases, compared with the gold standard 12-lead ECG detection results of medical heart rate measurement, the accuracy rate of ECG atrial fibrillation judgment of RealBeats? AI biological data engine is as high as 97.24% , PPG atrial fibrillation judgment accuracy rate also reached 95.52%.
AMAZFIT is equipped with the “Huangshan No. 1” chip independently developed by Huami Technology. Huangshan No. 1 is based on the RISC-V open source instruction set and has three important features: high performance, AI migration, and scalability. In terms of high performance, its computing efficiency is 38% higher than that of the ARM architecture; AI migration refers to it Integrated AI biological data engine, the monitoring of heart rate, ECG, and arrhythmia can be quickly calculated locally; and scalability means that it can be used as the main processor or work in conjunction with the main chip, such as Huami and The combination of Qualcomm Snapdragon processors makes it capable of local health monitoring.
Smart wearable devices rise as a national strategy
Tech giants have entered this track because China has a large and rapidly growing wearable device market and strong policy support.
According to the “2021 China Smart Wearable Device Industry Research Report”, China’s smart wearable device industry will maintain a rapid growth trend. With the rapid development of smart wearable devices in the domestic and foreign markets, the standardization of the smart wearable device industry has also been included in the policy list. At the same time, the implementation of the “Internet + health care” strategy is also accelerating the development of the industry.
In 2014, the Chinese Academy of Engineering launched the “China National Health and Medical and Health Development Strategy Research” project, and took “Development Strategy Research on Medical Devices and New Wearable Medical Devices” as a key research topic. With the increasingly prominent advantages of smart wearable devices in the medical field, the government has gradually paid more attention to medical-grade smart wearable devices. In 2015, the State Council issued “Made in China 2025”, emphasizing the need to improve the innovation ability and industrialization level of medical devices, promote breakthroughs in the field of intelligent manufacturing in technologies such as mobile Internet, cloud computing, and big data, and focus on the development of mobile wearables, remote diagnosis and treatment, etc. Medical products, smart wearable devices are rising as national strategies.