Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies
On Nov. 29, 2023, Vivos Therapeutics announced it received FDA 510(k) clearance for its line of Complete Airway Repositioning and/or Expansion (CARE) oral appliances for the treatment of severe obstructive sleep apnea (OSA). About Vivos CARE oral appliances Vivos’ removable CARE oral appliances represent [...]
On Nov. 9, 2023, Owlet announced it received De Novo clearance from the FDA for its Dream Sock, an over-the-counter medical pulse oximetry solution for infants. The device provides infants’ real-time health information to parents and caregivers. About the Owlet Dream Sock According [...]
Neurovalens announced Oct. 31 it has received FDA 510(k) clearance for its Modius Sleep device intended to treat chronic insomnia. By delivering a small and safe electrical pulse to the head for 30 minutes before bed, Modius Sleep is designed to improve insomnia. [...]
Sleepiz received FDA Class II 510(k) clearance for Sleepiz One+, a contactless device intended to measure heart rate and respiration rate in adult patients at rest or during sleep. About Sleepiz One+ Sleepiz One+ uses Doppler radar technology to provide passive vital signals. [...]
Honeynaps announced Sep. 25, 2023, that its SOMNUM artificial intelligence (AI) sleep disease analysis algorithm received FDA approval. The software leverages deep learning-based AI to perform real-time analysis of vast volumes of biosignals. About SOMNUM SOMNUM is software intended to aid in the diagnosis [...]
Beacon Biosignals announced in a press release on Sep. 13, 2023 that it received FDA 510(k) clearance for the Dreem 3S, an artificial intelligence (AI)-assisted wearable headband for sleep monitoring. The device allows patients to participate in home-based electroencephalogram (EEG) data collection. About the [...]
On Sep. 7, 2023, BodiMetrics announced that its circul pro Ring has received FDA 510(k) clearance as a pulse oximeter. According to the company, the device’s form factor and LED technology make it uniquely designed to accurately measure blood oxygen level on people with any skin [...]
On Sep. 7, 2023, Harmony Biosciences announced that the FDA granted orphan drug designation to pitolisant for the treatment of idiopathic hypersomnia (IH). The FDA’s orphan drug designation provides incentives for drugs and biologics for the treatment of rare diseases. About pitolisant Pitolisant is [...]
SLEEP 2023, the 37th annual meeting of the Associated Professional Sleep Societies LLC (APSS), was held on June 3-7, 2023 in Indianapolis, Indiana. Since its inception in 1986, SLEEP has become the premier forum on sleep medicine. Each year, the APSS is proud to [...]
On May 24, 2023, Zoll announced the FDA has approved the remedē System for conditional use with magnetic resonance imaging (MRI). The implantable transvenous phrenic nerve stimulation therapy is a treatment for adults with moderate to severe central sleep apnea (CSA). About the [...]