Bairitone Health received FDA Breakthrough Device Designation for Somnar, a non-invasive, skin-mounted “sleep sonar” sensor patch paired with an artificial intelligence-driven analysis platform that maps anatomy during sleep to identify the root cause of airway obstruction. About Somnar Somnar is a contact-based system [...]

On Feb. 17, 2026, Harmony Biosciences announced that the U.S. Food and Drug Administration approved a supplemental new drug application for Wakix (pitolisant) tablets to treat cataplexy in children ages 6 years and older with narcolepsy. About Wakix Wakix is a selective histamine-3 [...]

Alkermes announced the FDA granted Breakthrough Therapy designation to alixorexton, a novel, investigational, oral, selective orexin 2 receptor agonist, for the treatment of narcolepsy type 1, based on phase 1 and phase 2 clinical data. About alixorexton Alixorexton, formerly known as ALKS 2680, is a selective orexin 2 receptor [...]

Inogen Inc. has launched a new line of CPAP masks, marking the company’s entry into the sleep apnea market. The company said the Aurora CPAP masks expand its respiratory care portfolio beyond oxygen therapy to include treatment for sleep apnea. About Aurora CPAP [...]

On Dec. 17, SleepRes, Inc. announced it has received FDA 510(k) clearance for its Kricket PAP device, powered by Kairos Positive Airway Pressure (KPAP) for the treatment of obstructive sleep apnea in patients over 66 pounds. About Kricket PAP The Kricket PAP device [...]

On November 6, 2025, AIOMEGA announced it has received FDA 510(k) clearance for its oral appliance, AIO Breathe, in children and adolescents with mild to moderate obstructive sleep apnea (OSA). About AIO Breathe The AIO Breathe is a custom oral appliance designed to [...]

On Oct. 27, 2025, Good Sleep Co announced that the Hushd Pro Z-Link has received FDA 510(k) clearance. It is a precision-engineered mandibular advancement device intended to reduce or alleviate snoring and mild-to-moderate obstructive sleep apnea in adults. About the Hushd Pro Z-Link [...]