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.