FDA Signs Off Nyxoah's Genio Trial In Complete Concentric Collapse Patients

The FDA has approved  Nyxoah SA's  (NASDAQ: NYXH ) Investigational Device Exemption (IDE) to initiate a trial, called ACCCESS, to evaluate the Genio system for moderate-to-severe Obstructive Sleep Apnea (OSA) and Complete Concentric Collapse (CCC) of the soft palate.  The FDA had previously granted Breakthrough Device Designation to Genio to ... Full story available on Benzinga.com