The FDA has not authorized, cleared, or approved any smartwatch or smart ring
The U.S. Food and Drug Administration (FDA) has issued a safety communication advising against the use of smartwatches or smart rings that claim to measure blood glucose levels without piercing the skin. This warning is directed at consumers, patients, caregivers, and healthcare providers, emphasizing that the FDA has not authorized, cleared, or approved any such devices for this purpose. The alert distinguishes these products from smartwatch applications that display data from FDA-authorized devices, such as continuous glucose monitoring devices (CGMs), which do require skin piercing. The FDA's concern stems from the potential for inaccurate blood glucose measurements provided by these unauthorized devices, which could lead to serious errors in diabetes management. Such inaccuracies could result in taking incorrect doses of insulin or other medications, leading to dangerously low glucose levels, mental confusion, coma, or even death.
Wired's In-Depth Analysis
Continuous Glucose Monitoring (CGM) devices are advanced tools used primarily by individuals with diabetes to continuously track glucose levels in their body. These devices offer a significant advantage over traditional blood glucose meters by providing real-time data on glucose trends around the clock. A CGM system typically consists of a small sensor, usually placed under the skin, which measures glucose levels in the interstitial fluid. This data is then transmitted to a receiver or a smartphone, allowing users to monitor their glucose levels without the need for frequent finger-prick tests. CGMs can alert users to sudden changes in glucose levels, helping in better diabetes management by enabling timely adjustments in diet, exercise, and medication. This technology not only aids in stabilizing blood sugar levels but also plays a crucial role in reducing the risk of diabetes-related complications.
Blood pressure measurement devices that have been validated for clinical accuracy as determined through an independent review process.
High blood pressure (BP) that is uncontrolled is the major cause of mortality and disability. For the diagnosis and treatment of hypertension, reliable blood pressure measurement is critical. If the BP measurement instrument has been validated for clinical accuracy, that is a crucial aspect of correct measurement.