Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies
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 [...]
On Aug. 12, 2021, Jazz Pharmaceuticals announced the FDA approved a new indication for Xywav for idiopathic hypersomnia (IH) in adults. About Xywav Xywav, also known as JZP258, is a lower-sodium oxybate treatment taken at night to help treat multiple symptoms of IH, [...]
On July 28, 2021, Takeda Pharmaceutical Company announced the FDA granted Breakthrough Therapy designation to TAK-994, which may provide a future treatment option targeting the orexin deficiency underlying narcolepsy type 1. About TAK-994 TAK-994 is a Phase 2 investigational oral orexin agonist designed to [...]
On July 14, 2021, EnsoData announced its FDA 510(k) clearance of new capabilities and enhancements to EnsoSleep, an artificial intelligence (AI)-assisted sleep scoring solution that automates event detection in polysomnography (PSG) and home sleep apnea tests (HSAT). About EnsoSleep EnsoSleep is software-only medical device [...]
On June 30 the U.S. Food and Drug Administration (FDA) issued a safety communication in response to the voluntary recall by Philips of certain Philips Respironics bi-level positive airway pressure (BPAP), continuous positive airway pressure (CPAP), and mechanical ventilator devices due to potential health [...]
On June 14, Philips issued a recall notification for specific Philips bi-level positive airway pressure (bi-level PAP), continuous positive airway pressure (CPAP), and mechanical ventilator devices. The recall is in response to potential health risks related to the sound abatement foam component in [...]