The US Food and Drug Administration (FDA) on Wednesday warned healthcare professionals and consumers about the risks of using smartwatches or smart rings that claim to measure blood glucose levels without piercing the skin.
In its communication on safety, health The regulator clarified that it has never granted authorization to smartwatches or smart rings intended to measure or estimate blood sugar values themselves, nor to verify their safety or effectiveness.
Such devices are different from smartwatch applications that display data from FDA-cleared blood glucose monitoring devices that pierce the skin, such as continuous glucose monitoring (CGM) devices, the FDA said.
Companies like Medtronic (MDT), DexCom (DXCM), and Abbott (ABT) dominate the continuous glucose monitoring market.
Tech giants Samsung Electronics (OTCPK:SSNLF) and Apple (AAPL) are among those advancing technology for non-invasive blood glucose monitoring.
Inaccurate blood sugar 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.”