Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies
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 [...]
On Nov. 12, the Food and Drug Administration issued a news release with updated findings related to the June recall of certain Philips Respironics ventilators and positive airway pressure machines due to potential health risks related to polyester-based polyurethane sound abatement foam used in [...]
On Oct. 12, 2021, Withings announced its ScanWatch received FDA clearance to record electrocardiogram (ECG) and oxygen saturation (Sp02) measurements for atrial fibrillation detection. It also provides sleep tracking and analysis of sleep patterns. About ScanWatch ScanWatch is a wearable, Bluetooth-connected wrist-worn watch. [...]
Nyxoah announced Sep. 14, 2021, that the FDA granted breakthrough device designation to its Genio bilateral hypoglossal nerve stimulation system, which is intended to treat adult patients with moderate to severe obstructive sleep apnea (OSA) and complete concentric collapse of the soft palate. About [...]
On Sept. 1, Philips announced that it has received authorization from the Food and Drug Administration to “rework” the recalled first-generation DreamStation devices by replacing the sound abatement foam with a new material. Philips anticipates that the repair program will begin this month. The [...]