Aktiia’s Hilo Band Becomes First Cuffless Blood Pressure Monitor Cleared by FDA for Over-the-Counter Use

The FDA has cleared Aktiia’s G0 Blood Pressure Monitoring System, known as Hilo Band, for over-the-counter use in the U.S. This marks the first FDA clearance for a cuffless blood pressure monitor for OTC use in the country. The Hilo Band, already available in Europe, will be accessible to U.S. consumers in 2026. This milestone is seen as a paradigm shift in hypertension management.

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