Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies
On Feb. 18, 2025, PranaQ announced it received FDA 510(k) clearance for TipTraQ, a compact home sleep apnea test (HSAT) wearable that uses advanced biosensors and AI algorithms to detect sleep apnea events and analyze sleep architecture with clinical-grade accuracy. About [...]
On Feb. 5, 2025, Huxley Medical announced that the FDA has cleared the SANSA home sleep apnea test to use cellular data upload, eliminating the need for Bluetooth pairing or apps, reducing failed home testing and simplifying the diagnostic process. About [...]
On Dec. 20, Eli Lilly announced the FDA has approved Zepbound (tirzepatide) as the first and only prescription medication for adults with moderate-to-severe obstructive sleep apnea and obesity. Read the FDA press release announcing Zepbound's approval for sleep apnea. The American Academy of Sleep [...]
On Dec. 3, 2024, Beacon Biosignals announced FDA authorization of a predetermined change control plan (PCCP) for the Dreem 3S, a wearable EEG headband designed for sleep monitoring, allowing for continuous sleep staging algorithm enhancements. About the Dreem 3S The Dreem 3S uses integrated machine [...]
On Dec. 2, 2024, Movano Health announced FDA 510(k) clearance for the pulse oximeter in its EvieMED Ring. About the EvieMED Ring The EvieMED Ring is a finger wearable device featuring a small gap in the ring surface and slight flex to accommodate finger swelling. [...]
On Oct. 28, 2024, Neurovalens announced it launched its first product, Modius Sleep, an FDA-cleared, physician-prescribed medical device intended to treat chronic insomnia in adults. About Modius Sleep Modius Sleep is a portable, battery-operated neurostimulation device worn on the head for 30 minutes each [...]
On Oct. 17, 2024, Avadel Pharmaceuticals announced the FDA approved its supplemental new drug application for Lumryz for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. About Lumryz Lumryz is the only FDA-approved once-at-bedtime [...]
On Oct. 8, 2024, Happy Health announced it received FDA clearance for its Happy Ring, which monitors health metrics such as sleep, blood oxygen, heart rate, activity, temperature and brain activity. About Happy Ring Happy Ring is a wearable medical device smart ring [...]
On Oct. 8, 2024, Vivos Therapeutics, Inc. announced the American Medical Association (AMA) has issued new current procedural terminology (CPT) coverage and reimbursement codes applicable to all Vivos CARE oral medical devices, which will become effective Jan. 1, 2025. In a recent press release [...]
On Sept. 18, 2024, Vivos Therapeutics announced it received FDA 510(k) clearance for its oral appliance to treat moderate to severe obstructive sleep apnea (OSA) and snoring in children. About Vivos’ DNA appliance Vivos’ DNA appliance is an intraoral device designed to reduce [...]