LivaNova PLC 宣布，美國食品藥物管理局（FDA）已核准 aura6000™ 系統用於治療中度至重度阻塞性睡眠呼吸中止症（OSA）的成人患者，並授予上市前核准（PMA）。 該系統採用近端舌下神經刺激（p-HGNS）——一種獨特的神經刺激療法——來治療患有 […] 的 OSA 患者。
Tag: hgns
Nyxoah Boosts Manufacturing Investment in Belgium to Fuel International Expansion
Nyxoah SA has announced an important investment in Belgium to further scale its manufacturing capacity to support its continued growth in the United States and international markets. In addition to its existing contract manufacturing operations in the United States, the Company will expand its manufacturing footprint in Wallonia, reflecting Nyxoah’s […]
舌下神經刺激治療患者指南
治療睡眠呼吸中止症並無萬能的解決方案。持續氣道正壓通氣（CPAP）在過去近 40 年間一直是首選治療方式，但醫師們已意識到，部分患者無法耐受 CPAP 面罩，或無法長期持續進行 CPAP 治療。 如果您患有中度 […]
Nyxoah DREAM U.S. Pivotal Study Meets Primary Endpoints
Nyxoah SA has announced the DREAM U.S. pivotal study achieved a statistically significant reduction in the co-primary endpoints of 12-month AHI responder rate, per the Sher criteria, and ODI responder rate, both on an ITT basis. The DREAM study is a pivotal trial being conducted under an investigational device exemption […]
