Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies
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 [...]
Sibel Health announced it received new FDA 510(k) clearance for its ANNE One platform on May 10, 2023. The platform has now received clearance as a clinical-grade, continuous wireless monitoring solution for neonates, infants and adults. About ANNE One The ANNE One platform leverages [...]
Cumulus Neuroscience announced on May 4, 2023, that its dry-sensor electroencephalograph (EEG) headset has received FDA 510(k) clearance. The device is FDA-cleared for use in adults and adolescents for the remote acquisition, display and storage of EEG data. About the Cumulus EEG headset [...]
Avadel Pharmaceuticals announced on May 1, 2023 that the FDA granted final approval to Lumryz, an extended-released sodium oxybate medication. It is taken once at bedtime for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy. About Lumryz [...]
The AASM has created a gold standard of sleep records to validate third party automated sleep scoring algorithms for the Autoscoring Certification: Sleep Stage Pilot Program. The goal of this project is to establish objective performance requirements for third party automated sleep scoring [...]
On April 19, 2023, Noctrix Health announced it received FDA De Novo approval for its NTX100 Tonic Motor Activation (TOMAC) System, which is intended to treat symptoms of moderate to severe restless legs syndrome (RLS) and improve sleep quality in patients who are refractory [...]
On April 3, 2023, Happiest Baby announced the FDA granted De Novo approval to its SNOO Smart Sleeper, which keeps sleeping babies safely positioned on their back and uses continuous rhythmic sensations that mimic the experience of being in the womb. About the [...]