Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies
On Aug. 5, 2026, Takeda announced that the U.S. Food and Drug Administration approved Orzeyful (oveporexton) tablets for the treatment of narcolepsy type 1 in adults. Orzeyful is the first medicine approved to treat narcolepsy type 1 as a complete disorder, addressing the [...]
On July 16, HoneyNaps announced that Somnum v3.0, its artificial intelligence-based software for polysomnography analysis, received U.S. Food and Drug Administration 510(k) clearance under clearance number K253390. The FDA clearance expands the software's capabilities for automated analysis of sleep-disordered breathing. About Somnum v3.0 [...]
Attendees at SLEEP 2026 in Baltimore can connect with industry representatives in the exhibit hall, where companies will showcase the latest products, technologies, and services shaping sleep medicine. The exhibit hall offers an opportunity to explore new solutions, ask questions, and interact directly [...]
On May 19, Sunrise Group announced that the latest generation of its home sleep test, Sunrise Air, received FDA clearance. The device aids in the evaluation of obstructive sleep apnea in adults with suspected sleep-disordered breathing and expands on the capabilities of the earlier Sunrise system. About Sunrise Air Sunrise Air is a [...]
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 [...]
DARIEN, IL – The American Academy of Sleep Medicine congratulates Bairitone Health and Noctrix Health, whose innovations were selected as the people’s choice winners of the first AASM Sleep Medicine Disruptors Innovation Award. The votes were cast by attendees of Sleep Medicine Disruptors 2025, [...]