Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies
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 [...]
On March 21, 2023, Inspire Medical Systems, Inc. announced it received FDA approval to offer Inspire therapy to pediatric patients with Down syndrome. About Inspire therapy Inspire upper airway stimulation is used to treat patients with moderate to severe obstructive sleep apnea (OSA) [...]
Belun Technology announced it received FDA 510(k) clearance for its Belun Sleep System on Feb. 28, 2023. The Belun Sleep System comprises a wearable ring and proprietary deep-learning algorithms that aid in evaluating moderate to severe sleep-related breathing disorders in adult patients with suspected [...]
On Feb. 13, 2023, Sunrise announced it received FDA clearance for its second-generation home sleep apnea test (HSAT) device. The device uses artificial intelligence (AI) to aid in the diagnosis of obstructive sleep apnea and sleep-related breathing disorders. About the Sunrise HSAT device [...]
Prosomnus announced Nov. 2, 2022, that it received FDA 510(k) clearance for its ProSomnus EVO [PH] sleep and snore device, a precision oral appliance therapy (OAT) device. About ProSomnus EVO [PH] The ProSomnus EVO [PH] sleep and snore device is intended to reduce [...]