The FDA has given 510(k) clearance to health tech company Aktiia for over-the-counter use of its G0 Blood Pressure Monitoring system.
According to the FDA website, the device received clearance July 2.
The system, already available in Europe, is the first cuffless blood pressure monitor to be cleared by the FDA for over-the-counter use, according to a July 9 news release from Akitiia.
The device will be available to U.S. consumers in 2026, the release said.
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