FDA warns against use of smartwatches to measure blood glucose

The U.S. Food and Drug Administration (FDA) on Wednesday warned health care providers and consumers of risks related to using smartwatches or smart rings that claim to measure blood glucose levels without piercing the skin.

In its safety communication, the health regulator cleared that it has never granted authorization to any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own, nor reviewed their safety or effectiveness.

Such devices are different from smartwatch applications that display data from FDA-authorized blood glucose measuring devices that pierce the skin, like continuous glucose monitoring devices (CGMs), the FDA said.

Companies such as Medtronic (MDT), DexCom (DXCM), and Abbott (ABT) dominate the market for continuous glucose monitoring.

Tech giants, Samsung Electronics (OTCPK:SSNLF) and Apple (AAPL) are among those that are advancing technology for non-invasive blood glucose monitoring.

Inaccurate blood glucose readings can lead to errors in diabetes management, including taking the wrong dose of insulin or other medications that rapidly lower sugar levels.

The agency is working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorized smartwatches or smart rings that claim to measure blood glucose levels “using non-invasive techniques.”