Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies
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 [...]
SLEEP 2022, the 36th annual meeting of the Associated Professional Sleep Societies LLC (APSS), was held on June 4-8, 2022 in Charlotte, North Carolina. Since its inception in 1986, SLEEP has become the premier forum on sleep medicine. Each year, the APSS is proud [...]
Onera Health announced that its subsidiary in the Netherlands, Onera B.V., received FDA 510(k) clearance for Onera Sleep Test System (STS), a wearable patch-based system for polysomnography studies. About Onera STS Onera STS consists of four sensors applied to the forehead, upper chest [...]
On April 19, 2022, Fisher & Paykel Healthcare announced the U.S. launch of F&P Evora Full, a compact full-face mask for obstructive sleep apnea (OSA) treatment. The mask received FDA 510(k) clearance. About F&P Evora Full According to the company’s press release, the [...]
Google announced April 11, 2022, that Fitbit received FDA clearance for its photoplethysmography (PPG) algorithm to identify atrial fibrillation (A-fib). The algorithm will power Fitbit’s new irregular heart rhythm notification feature. About Fitbit’s PPG algorithm Fitbit’s PPG algorithm passively assesses heart rate while [...]
Wesper announced on Jan. 25, 2022, that it received FDA clearance for its Wesper Lab system, which assists trained personnel in the diagnosis of obstructive sleep apnea (OSA) with data from a wireless patch component. About Wesper Lab Wesper Lab is a digital [...]
On Jan. 10, 2022, Idorsia announced that the FDA approved QUVIVIQ (daridorexant) 25 mg and 50 mg for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. About QUVIVIQ QUVIVIQ is a prescription medication indicated for [...]
On Nov. 30, 2021, Acurable announced it received FDA 510(k) clearance for its AcuPebble SA100, a small wearable device that enables automated, remote home testing to detect obstructive sleep apnea (OSA) in adults. About AcuPebble SA100 AcuPebble SA100 senses, records and interprets a patient’s [...]