Medical device companies Dekang Medical (DexCom) is developing a blood glucose measurement applications, the application can display readings built-in Apple smart watch diabetes blood glucose meter. This app is expected to give Apple smart watches a foothold in the medical field as soon as possible.
Dekang Medical's blood glucose meter continuously monitors the body's blood glucose concentration. Dekang Medical has already displayed a picture of the app, which can be used to make blood glucose concentration data into a simple and clear chart, which is very convenient for smart watch users to view. The company said that the Apple Watch will be released in April, when the application will be developed.
Apple has not commented on this. Apple has not yet accepted any smartwatch apps, but Apple has provided developers with application development guidance and code to enable developers to develop smartwatch apps. The latest iOS system also includes built-in health and fitness apps.
The US Food and Drug Administration (FDA) has been treating such applications with caution. A group of software engineers have developed NightScout, a network system for monitoring blood sugar in diabetic patients. Most of the engineers have children with type 1 diabetes. In January last year, the FDA was forced to relax supervision. Although not licensed by the regulator, the system is still publicly available.
The approval of medical regulatory agencies is slow, medical technology innovation is extremely slow, and the organization has challenged the medical field with practical actions. The move also shows that Silicon Valley companies and software developers are increasingly concerned about medical services.
According to statistics, approximately 29 million Americans have diabetes, and 5% to 10% of them are type 1 diabetes. Type 1 diabetes patients rely on insulin and regular blood glucose testing to ensure that blood sugar levels remain at normal levels.
Dekang Medical Blood Glucose Meter monitors blood glucose levels using a miniature sensor implanted under the skin. This technique measures blood glucose every five minutes.
Previously, the FDA required blood glucose meters and related software to meet Class III medical device standards, which meant that such products were subject to the highest level of regulatory review. However, due to the emergence of NightScout, plus Dekang Medical submitted a separate iPhone application, the FDA revised its regulatory policy last month.
Currently, Dekang Medical Blood Glucose Meters still need to meet Class III medical device standards, but software that displays blood glucose data does not need to be registered with the FDA.
However, Dekang Medical still needs to ensure that its Apple Watch application complies with FDA regulations. However, with the revision of the policy, Dekang Medical can directly launch the application without obtaining the FDA's permission.
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