FDA Clears HoneyNaps’ AI-Powered Sleep-Scoring Software
The software leverages deep learning-based AI to perform real-time analysis of vast volumes of multi-channel/time series biosignals to quickly deliver diagnostic information.
The software leverages deep learning-based AI to perform real-time analysis of vast volumes of multi-channel/time series biosignals to quickly deliver diagnostic information.
Nyxoah announced operating results for the second quarter and first half of 2023, emphasizing advances in its investigational device exemption trial designed to support the marketing authorization of the Genio neurostimulator system for the treatment of OSA.
The approval of the extended-release formulation of sodium oxybate allows for uninterrupted sleep and full treatment benefits in a single bedtime dose for people with narcolepsy.
The FDA says current prescribing information for some prescription stimulants does not provide up-to-date warnings about the harms of misuse and abuse.
Read MoreThe device is indicated to reduce symptoms of primary moderate-severe restless legs syndrome and improve sleep quality in adults refractory to medications.
Read MorePhilips provides an update on field action for specific sleep therapy and ventilator devices involved in the company’s ongoing recall.
Read MoreKP1077 is currently being evaluated in a phase 2 clinical trial for the treatment of idiopathic hypersomnia.
Read MoreThe baby bed is designed to keep sleeping babies positioned on the back—a position known to lower the risk of sudden infant death syndrome.
Read MoreThe authorization allows the company to shorten the time to product availability following an anticipated final approval decision from the FDA.
Read MoreIn the wake of an investigation into a dental appliance that multiple lawsuits allege caused grievous harm to patients, the FDA has begun looking into the product, the Anterior Growth Guidance Appliance, according to a former agency official.
Read MoreThe company, which received FDA clearance for its first-generation ring in 2018, says the sleep system could potentially speed up OSA diagnosis for nearly 1 billion people worldwide.
Read MoreIf approved, Avadel expects once-at-bedtime Lumryz to be the treatment of choice for patients with narcolepsy-related excessive daytime sleepiness or cataplexy.
Read MoreThe FDA updated its Philips Respironics recall safety communication this month to provide updated information about medical device reports received from November 1, 2022, to December 31, 2022.
Read MoreThe FDA has cleared a new home sleep test, which uses a novel way to measure sleep—jaw movements—alongside the traditional signals of airflow and oximetry.
Read MoreThe drug developer expects to initiate a phase 2 clinical trial in patients with idiopathic hypersomnia before year-end 2022 and a second trial in patients with narcolepsy in 2023.
Read MoreThe FDA updated its safety communication on the Philips’ recall to include reporting of medical device reports received from August 1 to October 31, 2022.
Read MoreThe FDA announced the recall of certain Philips Respironics CPAP and BiPAP masks due to a safety concern involving magnets.
Read MorePhilips Respironics recalls more devices but the BiPAP recall is unrelated to the PE-PUR foam issue.
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