Trends in Wearable Medical Devices
01 In September 2020, Fitbit’s ECG application obtained FDA approval and CE mark. The app allows users to spot check signs of atrial fibrillation by themselves. This regulatory milestone appeared about two years after IWatch launched the ECG application. Just a few days ago, Apple announced that the sixth generation of IWatch will be equipped with blood oxygen function. Fitness trackers, etc., originally used as health wearable devices, are evolving into wearable medical devices. Companies such as Apple and Fitbit are seeking FDA approval to put these products on the market as wearable medical devices. Apple launched the IWatch series in September 2018, equipped with ECG applications and applications designed to analyze the pulse rate of users, shocking the medical device industry. Not long ago, Apple once again launched the sixth generation of IWatch, which is equipped with blood oxygen function, users can use this to further understand their overall health. Fitbit also announced that its ECG application has been approved by the FDA and will be listed as soon as possible. It’s as if Apple said to Fitbit: “We saw your ECG application, and give you a blood oxygen tracker.” 02 Since the proliferation of fitness trackers such as Fibit and mobile health apps, the FDA’s regulatory guidelines have undergone significant changes, making the field grow faster than ever. For example, in 2016, the FDA announced an enforcement policy for “general health” products, which are consumer products that are designed to maintain or encourage a healthy lifestyle and are less risky to users. Earlier last year, the agency issued two draft guidance documents outlining the FDA’s current thinking on low-risk health devices, enabling manufacturers to bring these products to the market faster and at lower prices. At the same time, as pointed out in the previous slide, consumer technology giants such as Apple and Fitbit still believe that in order to more directly compete with wearable medical devices such as AliveCor’s KardiaMobile ECG, they should invest more time and money in products. valuable. Last year, AliveCor obtained the FDA’s permission for KardiaMobile ECG testing BradyCardia and TachyCardia. 03 The new crown pneumonia has further consolidated the market’s demand for wearable medical devices and also validated this technology. Apple Watch blood oxygen trackers are an example of these devices helping consumers track potential symptoms of COVID-19. Another example is the new coronary pneumonia study released by FitBit in May last year. The goal of this research is to help build an algorithm that can detect new coronary pneumonia before symptoms appear. The company said that so far, more than 100,000 Fitbit users have registered in the United States and Canada, and more than 1,000 positive cases of the virus have been reported. Fitbit said that early results of the study show that it can detect nearly 50% of new coronary pneumonia cases the day before participants develop symptoms, with a specificity of 70%. 04 “The sixth-generation IWatch completely redefines the functionality of the watch. With powerful new features, including blood oxygen sensors and apps, IWatch becomes even more indispensable by providing further insight into overall health. Wearable medical device manufacturers are increasingly involved in data collection to support product development and application. In this regard, they are cooperating with medical institutions, researchers and even traditional medical device companies. For example, when Apple released the Apple Watch Series 6 last month, the company also announced three new health studies to explore how blood oxygen levels can be used for health applications in the future. 05 Despite the economic downturn caused by the new crown pneumonia, the digital health market still broke records in the first half of 2020. According to a research report by Research and Markets, between 2020 and 2027, the global wearable medical device market is expected to grow at a compound annual growth rate of 25.78%. In the United States, the market is expected to reach approximately $60 billion in revenue by 2027. As shown in the figure above, Mercom Capital Group reported that in the first half of 2020, Digital Health received $6.3 billion in funding, an increase of 24% over 2019. Among them, 794 million US dollars flowed into the mHealth application, and 321 million US dollars flowed into wearable sensors.
Health equipment & wearable medical equipment
The wearable health device of the past is the wearable medical device of the future
Continuous improvement of supervision and management
FDA guidelines further clarify the supervision of wearable medical devices
COVID-19
New crown promotes the development of new technologies for wearable medical devices
data:
Wearable device manufacturers use partnerships to build data
–Jeff Williams, Chief Operating Officer of Apple
market:
Record market size
