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First Patient Implanted in US Post-Approval Study for Genio Sleep Apnea Therapy
The BREATHE study will evaluate the long-term safety and effectiveness of the bilateral hypoglossal nerve stimulation therapy in adults with moderate to severe obstructive sleep apnea. Key takeaways: The multicenter, single-arm study will enroll up to 229
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FDA Clears Intraoral Biosensor for Sleep Apnea Therapy and Monitoring
The newly cleared prescription device combines an oral appliance with a built-in pulse oximeter to treat sleep-disordered breathing while continuously tracking blood oxygen saturation. Key takeaways: The FDA granted 510(k) clearance for a new intraoral bi
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Bedside Stand Aims to Improve CPAP Therapy Experience
An Orlando-based inventor has developed an adjustable bedside solution designed to address common patient frustrations with equipment organization and accessibility. Key takeaways: The newly developed adjustable stand provides a dedicated space for CPAP m
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FDA Classifies Sleep Apnea Device Recall as Class I Due to Firmware Defect
A recent recall of APAP devices has been classified as Class I after a firmware issue was found to cause unexpected shutdowns. Key takeaways: The FDA classified the recall of 20,160 Luna G3 APAP (Model LG3600) APAP devices as Class I due to a firmware def
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First-in-Class Orexin Agonist Secures Global Approvals for Narcolepsy Type 1
A newly approved oral treatment targets the underlying orexin deficiency in narcolepsy type 1, marking a shift from symptom management to mechanism-driven care across multiple international markets. Key takeaways: ORZEYFUL (oveporexton) has secured regula
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