Onera Health, a leader in transforming sleep medicine and remote monitoring, announced today that its wholly-owned subsidiary in the Netherlands, Onera B.V., has received 510(k) market clearance from the U.S. Food & Drug Administration (FDA) for its ground-breaking system for Polysomnography (PSG) studies, Onera STS, paving the way for widespread deployment of the patch-based technology across healthcare systems in the U.S.
April 28, 2022
· 4 min read