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Huawei has shifted to medical equipment from telecommunication? Huawei has 4 more medical products to enter the priority approval channel in China!
On August 23, China’s Guangdong Provincial Food and Drug Administration announced the review results of the second-class medical device priority approval application.
According to the announcement, Huawei’s four medical device products including wrist ECG blood pressure recorder, ECG analysis system, arrhythmia analysis system, and wrist single-lead ECG collector have entered the priority approval procedure for publicity.
From smart watches to medical devices, this entry into the priority approval indicates that Huawei’s wearable medical products are becoming more and more professional.
However, it is not new for smart watches to obtain medical device certification.
As early as 2018, Apple’s ECG APP and arrhythmia reminder function were approved by the FDA through the De Novo channel.
In October 2020, it obtained the 510(k) Class II medical device certification from the FDA. On June 21 this year, it officially obtained the Medical Device Registration Certificate from some countries Food and Drug Administration.
On October 23, 2020, the wrist single-lead ECG collector applied by Huawei Terminal Co., Ltd. obtained the medical device product registration certificate.
HUAWEI WATCH equipped with this technology was officially released on October 30, becoming Huawei’s first certified smart wearable medical device.
01. Huawei’s first certified smart wearable medical device
On October 30, 2020, Huawei released the WATCH GT 2 PRO ECG. It is Huawei’s first smart wearable medical device to obtain a Class II medical device registration certificate from the China National Medical Products Administration.
Accurately measure ECG
ECG is the abbreviation of electrocardiogram, which means electrocardiogram signal. Each time the human body’s heart beats the contraction and relaxation, it will send out corresponding electrical signals. The electrocardiogram records the electrical signals of the heart through the wires placed at various positions of the body.
Due to the different electrical signal strengths of various parts of the body, usually the more points are placed, the more accurate the measurement will be. When we do a physical examination in a hospital, doctors usually use 10 collection points for 12-lead ECG monitoring, that is, stick electrodes at 6 points on the hands, wrists, ankles, and chest.
When measuring with a Huawei watch, the user only needs to wear the watch correctly and touch the newly added electrode pads on the side of the Huawei Watch GT2 Pro ECG watch with a finger, 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 electric wave signals. In addition to choosing AI algorithms to interpret electrocardiograms, Huawei has joined forces with the “National Telemedicine and Internet”. The medical center is an authoritative national medical center.
Professional doctors from selected tertiary hospitals provide artificial electrocardiogram interpretation services, and provide the signature of the physician. The report gives the results of ECG interpretation, helps users find the high risk of arrhythmia early, and manages heart health independently.
Feedback results can be reported within 1-2 minutes at the earliest in working days.
Cooperate with China 301 Hospital to study atrial fibrillation and premature beat screening
Huawei cooperated with 301 Hospital to launch a heart health research project. Since 2018, the innovative team of Professor Chen Yundai and Guo Yutao of the Department of Cardiology of the 301 Hospital has applied the photoplethysmography (PPG) technology of Huawei’s smart wearable device to atrial fibrillation screening, screening the atrial fibrillation population, and supporting 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 technology (PPG)
Photoplethysmography technology (PPG) detects the heart rate by detecting the amount of visible light, such as the reflection of green light in human tissues.
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, which is processed and calculated by the subsequent processor (low-power MCU) to get accurate Heart rate.
More than 1.43 million Chinese users participated
As of May 31, 2020, a total of more than 1.43 million Chinese users have downloaded the Heart Health Research App on the Huawei App Market, and 3300+ people with suspected atrial fibrillation have been screened out, 2000+ users have been followed up for medical treatment, and 1900+ users have been integrated through atrial fibrillation. The management platform MAFA connects to collaborative hospitals for diagnosis, and the diagnosis rate of atrial fibrillation is 94%;
In October 2019, Huawei GT2 added premature beat screening based on atrial fibrillation screening. 440+ users with high risk of premature beats have been screened, 210+ users have been followed up for medical treatment, and 190+ have been diagnosed with premature beats.
The diagnosis rate of premature beats is as high as 92%;
At present, these users have entered the 301 MAFA platform to obtain integrated management of arrhythmia.
Research results are internationally recognized
Professor Chen Yundai said, “This study shows that continuing to wear smart devices at home is a feasible strategy for screening people with atrial fibrillation, which will help improve the early diagnosis and early intervention of atrial fibrillation.”
This research has been published in the world’s top journal “Journal of the American College of Cardiology” (JACC) and the international top medical journal “European Journal of Cardiology” (EHJ) in April and May 2020 in the field of the global heart and cardiovascular system. .
Medical class blood glucose monitoring software
After HUAWEI WATCH is connected to the minimally invasive sensor, you can view the current blood glucose in real time on the watch through medical-grade blood glucose monitoring software. If abnormal blood sugar occurs, it will vibrate to remind you.
Currently, only the matching Miqi blood glucose meter (device model: RGMS-III) is supported. The blood glucose meter needs to be purchased separately by the user. The user needs to download and configure the related Miqi blood glucose monitoring software on the watch.
In addition, the device also supports measurement of blood oxygen saturation, fall alarm, sleep monitoring, and exercise recording functions.
02. Huawei’s layout in the medical industry
Relying on its 5G technology advantages and huge R&D investment, Huawei will not only maintain the number one shipment of smart watches, but also lead the way in the number of medical device certifications it has obtained. It also has a leading edge in the medical layout.
At present, the entry point for Huawei to enter medical devices is only wearable devices, but it is difficult to guess whether it will expand into other fields in the future. However, no one doubts Huawei’s ability to expand into other medical device fields.
Huawei’s ambitions in the medical industry go far beyond medical devices.
As early as 2016, Huawei released the “White Paper on 5G Application Directions in 5 Major Industries”. One of them is the application of 5G in the medical industry, including remote monitoring of wearable medical care, remote surgery, remote imaging consultation, telemedicine, and asset supervision.
Huawei changed the company’s business scope in March 2019, adding new businesses such as the sales of medical devices (type 2 medical devices).
Glory Terminal Co., Ltd., established on April 1, 2020, also once again involved in the field of medical devices, further expanding the medical territory. At the end of November 2019, the business of Deep Thinking Artificial Intelligence Robot Technology (Beijing) Co., Ltd. invested by Hubble Technology Investment Co., Ltd., a wholly-owned subsidiary of Huawei, changed its business, selling medical devices Class I and II, computers, software, and copying equipment.
Relying on big data, cloud computing technology and other related technologies and equipment, Huawei has established cooperation with a number of large general hospitals in the field of digital hospital construction.
03. ECG devices
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 Apple Watch Series 4, which was approved by the FDA.
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. The ECG electrocardiogram function can distinguish whether the sinus rhythm is normal, irregular or accompanied by sinus atrial fibrillation in only 30 seconds, and draw a heart rate chart with detailed data in the iOS health APP, which can be saved in PDF format .
Huawei (Huami) AMAZFIT Mi Dong Health Watch
AMAZFIT Midong health watch adopts the high-precision biological tracking optical sensor independently developed by Huami Technology-BioTracker™ PPG sensor, which can collect heart rate data at a sampling rate of 50 Hz for 24 hours without interruption. The detection interval is short and the monitoring data is accurate. higher.
The AMAZFIT Midong Health Watch is also equipped with an ECG sensor. It innovatively adopts a four-sided surround press design. There are metal sheets around the watch frame. Users can measure with a more free posture and increase the metal contact area. , Reduce the impedance, make the 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, comparing the results of 12-lead ECG, the gold standard for medical heart rate measurement, the accuracy of ECG atrial fibrillation judgment by RealBeats™ AI biological data engine is as high as 97.24%. , The accuracy rate of PPG atrial fibrillation judgment has 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, compared to the ARM architecture, its computing efficiency is 38% higher; AI migration refers to it Integrated AI biological data engine, heart rate, ECG, and arrhythmia monitoring can be quickly calculated locally; and scalability means that it can be used as the main processor or work with the main chip, such as Huami and The combination of Qualcomm Snapdragon processors gives it the ability to monitor local health.
(source:internet, reference only)