The Magazine for Sleep Professionals
Thursday, November 12, 2026
Vitacore announced that it has received a Medical Device Licence (MDL) from Health Canada for FormFit™, the world’s first fully custom-fit medical-grade silicone CPAP mask. With regulatory approval secured, Vitacore is officially launching FormFit™ across Canada, direct-to-consumer at vitacore.com/formfit and through participating sleep clinics and healthcare providers nationwide. The proprietary […]
Philips announced that Philips Respironics DreamStation BiPAP AVAPS devices, which include S, T, S/T, and PC modes with AVAPS, are available for sale in the United States for new set-ups for patients with obstructive sleep apnea (OSA) and respiratory impairment, who are both >7 years of age and weighing 40-66lbs. The […]
Nihon Kohden announced it is expanding the reach of NomadAir® with Connect — its established at-home sleep apnea diagnostic system — into dental sleep medicine. The company will feature the solution at the American Academy of Dental Sleep Medicine (AADSM) Annual Meeting, taking place May 1–3 in Chicago (Booth 408). The expansion […]
ProSomnus Sleep Technologies announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision […]
LivaNova PLC announced the U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) for the aura6000™ System for the treatment of adult patients with moderate to severe Obstructive Sleep Apnea (OSA). The System utilizes proximal hypoglossal nerve stimulation (p-HGNS), a differentiated neurostimulation modality, to treat OSA in patients with […]
Wearable devices and digital apps that are available to consumers are emerging as potential tools in neurological care. These include smart watches and fitness trackers to monitor heart rate, physical activity, sleep and other health factors. To provide neurologists with guidance on the use, limitations and evidence on non-U.S. Food […]
REMSleep Holdings, Inc., developer of the FDA-cleared DeltaWave(TM) nasal pillow system, announced the full commercial launch of the DeltaWave product portfolio across all U.S. distribution channels, including durable medical equipment (DME) companies and institutional sales. With expanded FDA 510(k) clearance secured on January 15 and Medicare PDAC coding approved for every product […]
Resmed, announced the launch of the AirTouch™ F30i Comfort mask in the United States, a new CPAP (continuous positive airway pressure) full face mask. With a soft, breathable1 fabric, the AirTouch F30i Comfort is designed to help more people start and stay on CPAP therapy. The AirTouch F30i Comfort reflects Resmed’s dedication […]
Aesyra SA has announced the successful completion of its clinical investigation evaluating the efficacy and safety of AesyBite™ Active, an intelligent oral appliance designed to treat and prevent sleep bruxism through biofeedback. The clinical investigation demonstrated that AesyBite™ Active achieved a statistically significant and clinically meaningful reduction in sleep bruxism activity, exceeding the […]
