The FDA has issued a warning letter to BMC Medical Co., Ltd., the Beijing-based manufacturer behind the Luna and G3X lines of CPAP and APAP devices sold in the U.S. through distributor 3B Medical (doing business as React Health) of Dublin, Ohio. The letter, dated May 20, 2026, stems from […]
Product News
Can a Handheld Device Teach Your Patients to Breathe Their Way to Better Sleep?
Most sleep clinicians know the evidence for slow-paced breathing. Fewer have found a practical way to get patients to actually do it consistently, in the dark, without reaching for their phone. That gap is what moonbird was designed to close. Moonbird is a handheld tactile breath pacer: it expands and […]
Wesper to Unveil First Multi-Tier Sleep Diagnostic Ecosystem for Personalized Sleep Care at SLEEP 2026
Wesper unveiled its multi-tier sleep diagnostic ecosystem at SLEEP 2026, the annual meeting of the Associated Professional Sleep Societies. The ecosystem brings two purpose-built diagnostic pathways, Wesper Lab and Wesper Lite, onto one platform, one patient record, and one interpretation pipeline, so physicians can match the right test to the right […]
Vitacore Announces World-First Custom-Fit CPAP Mask Following Health Canada MDL Approval
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 Expands DreamStation Access for Lower-Weight Patients
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 […]
LivaNova Receives U.S. FDA Premarket Approval for aura6000 System to Treat Moderate to Severe OSA
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 […]
Bleep Sleep Brings Patient Experience Under One Roof
AAN Issues Guidance on Wearable Devices
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 […]
Resmed Introduces Full Face Fabric Mask Designed for Comfort and Improved Sleep Health
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 […]
Fisher & Paykel Healthcare launches Nova Nasal Mask in the U.S.
Fisher & Paykel Healthcare has announced the United States launch of its newest nasal PAP mask for treating obstructive sleep apnea, the F&P Nova Nasal mask. Building on the success of the F&P Nova Micro™ and F&P Solo™ masks, the new F&P Nova Nasal delivers advanced technology to enhance mask […]













