Medical Devices

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.

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.

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.

The FDA is exploring how to regulate medical devices that incorporate artificial intelligence (AI) and machine learning (ML), acknowledging that their traditional regulatory framework is not fully equipped for the adaptive nature of these technologies. Traditionally, the FDA regulates medical devices through pathways like premarket clearance (510(k)), De Novo classification, or premarket approval, and also reviews significant modifications to existing devices. However, AI and ML-driven software changes often necessitate a premarket review due to their dynamic nature.

Blood pressure readings taken in a physician's office can vary due to timing, equipment, and biological factors. Studies have linked variability between visits to an increased risk of cardiovascular disease and death, but little was known about its real-world implications. A retrospective cohort study of over 500,000 adults with more than 7.7 million blood pressure measurements found that visit-to-visit variability in blood pressure was associated with an increased risk of cardiovascular events and all-cause mortality. The study's findings suggest that blood pressure management needs to be reassessed to better account for visit-to-visit variability in real-world practice.