Aktiia’s Hilo band becomes first cuffless blood pressure monitor cleared by FDA

Hilo Band has received FDA clearance , marking a global first in cuffless blood pressure monitoring for consumer use. This makes it the first cuffless blood pressure monitor authorized for OTC use in the United States.

Already CE-certified and available in Europe under the Hilo brand, the device uses optical sensors to continuously measure blood pressure without the need for a traditional cuff. This marks a paradigm shift in how individuals monitor and manage hypertension, one of the world’s leading health challenges.