What are wearable medical devices introduced by glove manufacturers

What is wearable medical device

Develop medical imaging equipment, medical robots, new implant devices, new biomedical materials, in vitro diagnostic technology and products, home medical monitoring and health equipment, wearable devices, traditional Chinese medicine medical equipment, suitable primary diagnosis and treatment equipment, mobile healthcare and other products. It can be seen that wearable medical devices will be a popular industry for future development. In addition, in the research and development of health monitoring products, the combination of wearable medical devices and mobile communication enables people to remotely monitor health data. This Internet plus medical model brings new opportunities for the development of wearable devices.

In the field of medical devices, wearable medical devices usually refer to portable devices that can be worn on the body or integrated into the user's clothing or accessories. They usually have the characteristics of miniaturization, low power consumption, and connectivity, and are commonly used for the collection, processing, and analysis of human and situational data, and are loaded with standard communication modules. Wearable devices have the ability to flexibly collect data according to different needs, as well as the characteristics of easy use and portability, breaking through the limitations of time and space, making it possible for users and patients to access medical services anytime and anywhere. These large, continuous, and contextualized medical data provide a basis for various medical decisions, promote the development of healthy lifestyles, and improve disease monitoring, diagnosis, and treatment.

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It should be noted that when the data from wearable devices is used as an important basis for diagnosing, treating, and other aspects of patients, the device belongs to a type of medical device, which requires CFDA certification and application for a medical device registration certificate before it can be applied in the corresponding market.

Wearable medical devices come in various forms and functions, from sci-fi helmets to skin patches, and even sensors on clothing. Different forms of wearable medical devices have entered the consumer market at a speed beyond our imagination.

Wearable products are diverse and constantly evolving. Taking therapeutic medical devices as an example, from traditional electric heat therapy for the waist, hearing aids, sleep caps, waist straps, synthetic resin eye implants, wearable heart rate defibrillators, pain relief therapy devices, etc., to back treatment equipment (back sensors monitor back movement to relieve pain, data is used for treating and managing chronic kidney disease and spinal cord injury), artificial pancreas systems (including blood glucose monitors, insulin pumps, safety controllers, automatic insulin injection), and rewalk (helping spinal cord injury patients walk again), it can be seen that therapeutic wearable medical device products are constantly innovating and developing towards smarter and more functional directions.

At the same time, in the field of wearable medical devices, the development is more rapid, and the monitoring category of wearable medical devices cannot be ignored, which can be roughly divided into sports and health categories and patient monitoring categories. For sports and health products, it is common to monitor human body data such as exercise volume, calorie consumption, heart rate, respiration, etc., such as Xiaomi wristbands, LeXin wristbands, etc. Whether such products belong to medical devices still needs further judgment. Patient monitoring products usually obtain data such as patient temperature, blood pressure, blood glucose, blood oxygen, electrocardiogram, etc. There are also some special products, such as smart underwear that can monitor breast health and smart vests that can monitor changes in lung fluid accumulation in heart failure patients.

Undoubtedly, although there are still many problems, the market for wearable medical devices has flourished.

At present, CFDA does not have a targeted definition and classification for wearable medical devices. Relevant products need to refer to relevant regulations based on their working principles and expected uses when registering. However, due to their special usage methods and environments, there are many differences and areas that need to be noted when registering compared to traditional products.

Next, we will analyze and introduce wearable medical devices in terms of registration process, clinical evaluation, and system establishment.