October 8, Guangdong Provincial Food and Drug Administration issued
Outside arm-less single electrocardiogram collector, early August 23rd, Guangdong Provincial Medical Product Inspection Administration issued "Guangdong Provincial Second Class Medical Instrument Preference Program Results Announcement (49th) 》Indicate that there are three medical equipment entry priority procedures. Separated from Arm electrocardiogram and blood pressure record (MLY-B10, MLY-B11), Electrocardiogram analysis system (ECG-1), Cardiac rate failure analysis system (PPG-1).
Prematurely-related medical examination and distribution office
Early in May 2021, what has been done since the beginning of May 2021, has been opened by the research institute to carry out blood pressure measurement equipment, as well as in Japan A well-known mechanism for high blood pressure management research, exploring new active health management for early dry blood pressure. During the first half of the year, the medical equipment order trial was approved to measure blood pressure, and the first step was to open the order trial.
The end of August, when the singer's organization was under review, in recent years, there are many applications for health concepts and intelligence, and the ability to measure ECG, blood pressure, etc. is constantly appearing. , blood pressure and other functional breakthroughs. Accompanied by technological and application layer breakthroughs, product exploitation patterns and possible development changes, no hard work required, long-term comprehensive service. The singer has a very popular network in this area, a lively meeting place, and a good customer service.
Information on Tengan Research APP, Huawei Ending Co., Ltd., Huawei Technology Co., Ltd., is currently open to the public for a wide variety of medical consultations, such as the 2016 application for "a kind of heart rate testing method and apparatus" and "heart rate testing method and system", etc., at the same time. The company specializes in the design and manufacturing of low-level electrocardiogram measuring equipment, such as "a kind of electrocardiogram measuring equipment", and the high-precision "electrocardiographic measuring equipment, circuit and method", etc. At present, Huawei Technology Co., Ltd. has applied for more than 100 applications for the international category of "medical equipment", and has completed 44 applications.
In February of this year, Huawei Co., Ltd. published information on the use of electrocardiographic measurement equipment and methods, and the implementation of the present invention and the medical equipment technology area, as well as specific areas, and the use of electrocardiographic equipment. sum method.
Hands-on handbook for old people in the world, transfer to the battlefield
Please note, on June 25, the National Medical Examination Administration Bureau issued a medical device ratification document (entry) waiting notice, part 1 One item is Apple Inc.'s mobile electrocardiogram, the order number is "National Machine Injection 20212210223".
Origin: National Licensing Administration Bureau Network Station
Hua Tai Securities analysis name, in recent years, out of the first generation of heart rate monitoring, Apple has added ECG, blood pressure, etc. to the table. This product has a "cardiogram" function in China, and it is also advantageous to use Apple's hand table to increase the amount.
Hua Tai Securities, since September 2014, the first Apple Watch, excluding new products not released in 2015, the company has maintained the lowest level of intelligent performance every year. Coming from the product functionality, Apple Apple Watch functionality has been steadily increasing, and the product sales volume has been steadily increasing. As a result, Apple's intelligent handbook sales volume increased from 14.7 million copies in 2017 to 32.04 million copies in 2020, making it the world's largest intelligent handbook supplier.
If you want to buy medical products from Apple, please explain a problem. .
As an example, in early 2018, the ECG APP's heart rate failure function was passed through De Novo and received FDA approval; October 2020, received FDA 510(k) II medical device approval On June 21, 2021, officially obtained the medical instrument registration certificate from the National Tax Agency.
Domestic Enterprises Never Fall Back，September 24, 2020，OPPO Announced OPPO Watch ECG Global Headquarters，Announced This Equipment ECG Holds Control Functional Intelligent Hand Display Acquired NMPA Medical Instrument Two Labels，This Is The Headquarters Invoice of the Smart Watch; On October 23, 2020, Huawei End Co., Ltd. applied for an arm single electrocardiogram collection device for medical equipment, and on October 30, the technical HUAWEI WATCH was officially released. Ended up becoming the original intelligent medical equipment.
Second-class medical equipment ordered by the National Pharmaceutical Administration Bureau with certified intelligent medical equipment
Commonly used "skills" for medical products that can be worn
Unfortunately, major commercial institutions have added intelligent hand-to-hand health functions, and the results of the domestic test result have been further reviewed in the direction of medical equipment, but the domestic medicine has just been acquired. There are only four types of instrument-certified ECG functional intelligent handsets, which are divided into four categories: OPPO, apple, Chinese rice. A common medical term used in medical practice, which can be introduced by the instrument family, is also a product of this series.
precise measurement electrocardiogram
ECG is an electrocardiogram copy, intention is an electrocardiogram signal. Each time the human body produces a heartbeat, the corresponding electric signal generated by the city, the correct ECG signal passes through each position of the body, and the electric signal comes from the heart. Due to the difference in the strength of the electric signal in each part of the body, it is usually due to multiple measurements over the points. When we were in the hospital, we used 10 points for the regular meeting of medical doctors, and 12 guided electrocardiograms, immediately for two arms, two arms, and 6 points at the chest. Then pass through the hand display to check the correct hand display, and pass through the hand finger touch display on the Watch GT2 Pro ECG hand surface with new electrical electrodes, 30 seconds as fast as possible to generate result report.
It is very difficult for ordinary people to see the radio waves that are active in the daily life of many people. In addition to the selection of AI calculation method analysis electrocardiogram, Huawei is a combination of "national long-term medical care and mutual communication network", the medical center is a powerful national medical center, and the artificial electrocardiogram analysis service provided by the professional doctors of the selected three top hospitals, and has a famous doctor. Report, predictive electrocardiogram results, help and premature cardiac arrhythmia high fever, self-management mental health. Result within 1-2 minutes of working day.
Photoelectric Power Wave Technology (PPG)
Co-produced by Huawei 301 Hospital, released heart health research items. Originated in 2018, Department of Cardiology, 301 Hospital, Chen Dai, Professor Guo Yutao, a new team borrowed from the new team to use the photovoltaic wave technology (PPG) application for intelligent drilling equipment, a group of people who were sent out, and a multi-disciplinary team support room.颤Management platform (mobile Atrial Fibrillation Application, mAFA) provides coordinated management strategy, first-class practical management, second-class prevention and patient-participating self-management.
Photoelectric Power Wave Technology (PPG) can be measured through the light, and the amount of reflection in human tissue can be measured. Ordinarily, there are two or three green LED hands that emit visible light, and then an intermediate optical sensor is used to process the reflected return light, and the post-processing unit (low-cost MCU) is processed and processed. target rate.
Medical grade blood glucose test
After installing the HUAWEI WATCH connected micro-sensor, you can see the actual blood sugar at the time when the blood sugar level is checked on the table, and you will wake up with a sudden shock. For the time being, we used Biqi Glucose (equipment model number: RGMS-III), which is a single purchase for blood sugar needs, and is related to biqi blood sugar testing. Other equipment support measurement blood fatigue, roll over alarm, sleep monitoring, exercise recording function.
I don't like the equipment,I'm sorryIt's been a long time since I've been awayMedical
I'm borrowing it 5G technology advantage, more than massive research and development investment, the number of sales is the first, the number of acquired medical equipment certification is far away, and the priority is the acquisition of the medical distribution bureau. In the near future, it is possible to insert a device that can be inserted into the machine to kill a doctor, but in the future it will not be possible to meet in other areas. However, the ability to operate other medical equipment in the field of medical equipment is suspected.
Of course, the ambitions of the medical industry are not far from the medical equipment. Early in 2016, "5 G major business application directions for 5G" was released. One of them is 5G medical application, comprehensive long-distance monitoring, medical examination, long-distance surgery, long-distance imaging, long-distance medical care, and five major areas of asset management.
Currently in March 2019, the company's new medical equipment (second-class medical equipment) business. Established on April 1, 2020, Rong Yao End Co., Ltd. has re-opened the medical equipment field, and has recently started a large medical edition. At the end of November 2019, under the banner of Huawei Technology Investment Co., Ltd., the investment deep thinking artificial intelligence machine and human technology (Beijing) Co., Ltd. was redeveloped, and medical equipment I, II, computers, software and control equipment.
Completed the construction of Yotaya large-scale general hospital.
Intelligent hand display progress entryECG pathSteps
OPPO Watch ECG version OPPO Watch ECG version recruitment single guide Coordinated design, complete medical grade measurement accuracy, passed the National Pharmaceutical Administration (NMPA) certification, must be domestically approved two types of medical equipment order certification and official market intelligence chart. Very convenient to use OPPO Watch ECG version of ECG measurement: Under normal conditions, use the "ECG" APP, just put your finger on the belly of your hand, hold the key, wait for 30 seconds, and you can get the ECG immediately after counting. Definitive hand-me-downs are delivered together.
OPPO Watch ECG provides two types of electrocardiographic analysis methods.
AI analysis calculation analysis complete analysis report within 3 seconds, ability to export from index analysis to health construction omnidirectional answer, the calculation method is based on national distance medicine and mutual network medical center support, over 100 nationwide Multi-family hospital million bills exam. The explanation is due to the fact that Masato is on-line for ECG analysis, every day from 08:00 to 17:00. 00 Left and right completed explanations, each time the explanation meeting will be different depending on the selection of the medical profession.
Apple Watch
In effect, after Apple Watch 4, the ECG function has been completed. Early in 2018, the Apple Watch Series 4 was launched with ECG and electrocardiogram detection, and was approved by the FDA. However, due to the fact that this function is attributed to medical equipment, Apple has not been able to pass through my country's medical equipment certification. On June 21, 2021, the official license for medical equipment was obtained from the National Tax Agency.
The imminent Apple Watch Series 6 can be monitored, once the heart rate is too high or too low, the heart rate app has been released. ECG electrocardiogram function only requires 30 seconds or less to distinguish whether the heart rhythm is normal, whether it is normal or not, and there is a heart rate chart available in the iOS health APP. .
Huami AMAZFIT US health chart
AMAZFIT US-based health hand-held self-developed high-precision bio-tracking optical sensor --- BioTracker™ PPG sensor, capable of 24-hour non-stop 50 Hz detection rate, short measurement interval, Higher accuracy of counting.
AMAZFIT US motion health hand-mounted ECG electrocardiogram sensor, four-sided pressure-applied design with innovative location, four-sided metal piece around the hand-panel, free-to-use, free-to-use posture progress measurement, at the same time increased Metallic contact surface, low resistance, and ECG signal refinement.
Department of Cardiovascular Medicine, Peking University First Hospital. Achieved 97.24%, PPG room judgment approval rate reached 95.52%.
AMAZFIT is equipped with Huangshan No. 1 core piece, which is self-developed by Huangshan Technology. Huangshan No. 1 "Based on RISC-V development command collection, high efficiency, AI transfer, expandability three important special campaigns. High efficiency, relative ARM architecture, its operation efficiency high 38%; AI transfer instruction Comprehensive AI biological number calculation, heart rate, electrocardiogram, heart rhythm can be measured locally and quickly; Combined with high-tech dragon treatment equipment, it has the ability to monitor local health.
Intelligent drilling equipment rises to become a national strategy
Science and technology giants have entered this path, because China has a large and rapidly growing drilling equipment market, and so on. Powerful policy support.
[2021 China Intelligent Wearable Equipment Industry Research Report], China Intelligent Wearable Equipment Industry Maintains Fast Growth, Projected 2020-2025 Market Growth Rate of 20%, By 2025 Market Expected to Break through 1500 million yuan. Accompanying intelligent wearable equipment in the domestic and foreign markets is developing rapidly, intelligent wearable equipment operation standardization construction and non-repeating policy, at the same time promoting the strategy of "mutual network + health care" strategy and constant acceleration of the development.
In 2014, the Chinese Academy of Engineering Research, “Strategic Research on the Development of China's National Health and Medical Care Business,” and General Manager, "Strategic Research on the Development of Medical Equipment and New Types of Medical Equipment," a key research project. Accompanying intelligence-enabled equipment in the medical field has been prioritized, and the government has increased the importance of medical-grade intelligence-enabled equipment. In 2015, the National Academy of Science and Technology announced "Made in China 2025", the new capacity and industrialization level of high-end medical equipment production, the breakthrough in technology-based and intelligent manufacturing areas such as dynamics, communication, computing, and large numbers, key development, long-distance research, etc. Medical products, intelligent wearable equipment rise as a national strategy.
Luffy Liu
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