Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies
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 [...]
On Sept. 9, 2024, Apple unveiled Apple Watch Series 10, a smartwatch featuring new obstructive sleep apnea (OSA) notifications. About Apple Watch Series 10 Apple Watch Series 10 offers advanced capabilities, a thinner profile and larger display screen than previous models. Building [...]
On Sept. 9, 2024, Withings announced that it received FDA 510(k) clearance for its Sleep Rx mat, a contactless device for diagnosing obstructive sleep apnea (OSA). About Sleep Rx Sleep Rx is an under-the-mattress device intended to aid in the diagnosis of OSA [...]
On Aug. 28, 2024, OxiWear announced it received FDA 510(k) clearance for its oxygen data collection device, an ear pulse oximeter designed for continuous, real-time measurement of blood oxygen saturation (SpO2) and pulse rate. About the OxiWear System The OxiWear System is a [...]