On Jan. 7, 2026, the U.S. Food and Drug Administration (FDA) said that it will limit regulation of wearable devices and software designed to support healthy lifestyles, issuing new guidance to clarify its regulatory approach.

The guidance, along with comments from FDA Commissioner Marty Makary, adds to existing policy that classifies low-risk wellness tools, such as fitness apps and activity trackers that encourage exercise, as non-medical devices exempt from stringent regulation, provided they do not make claims related to disease diagnosis or treatment.

Shares of continuous glucose monitor manufacturers Abbott, Medtronic, and Dexcom closed between 1% and 4% higher. U.S.-listed shares of fitness smartwatch maker Garmin ended nearly 3% higher.

Last year, the FDA issued a warning letter to fitness band maker WHOOP, saying its blood-pressure insights feature blurred the line between wellness and medical devices by estimating systolic and diastolic values used to diagnose hypertension.

The agency also sent out a broader warning to consumers about the risks posed by unauthorized devices.