Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies
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 [...]
The modern sleep disorders center is seeing a shift in how day-to-day tasks are being performed. Artificial intelligence technology has opened the door for highly accurate auto-scoring solutions that will likely play a bigger role in AASM-accredited facilities in the future. While the [...]
On July 6, 2022, ResApp Health Limited announced that SleepCheckRx received FDA 510(k) clearance as prescription-only software as a medical device. It is intended to record respiratory patterns during sleep to pre-screen patients for obstructive sleep apnea (OSA). About SleepCheckRx SleepCheckRx is an at-home [...]
On July 7, 2022, Cerebra Medical announced it received FDA 510(k) clearance for its Cerebra Sleep System, a lab-quality in-home polysomnography (PSG) that is fully self-applied by the patient, without the presence of a technician. About Cerebra Sleep System The Cerebra Sleep System [...]
On June 28, 2022, Apnimed announced that the FDA has granted Fast Track designation to AD109, its novel oral pharmalogic for the treatment of obstructive sleep apnea (OSA). About AD109 AD109 is a novel investigational combination dosed once daily at bedtime and is [...]