The Magazine for Sleep Professionals
Wednesday, September 30, 2026
BMC Medical Co., Ltd. has recalled its Luna G3 APAP device (model LG3600) due to a firmware defect that can cause the machine to display an error message and shut down automatically, cutting off therapy delivery, the U.S. Food and Drug Administration announced. The FDA has classified the action as […]
Frost & Sullivan is pleased to announce that SleepRes has been recognized with the 2026 North America New Product Innovation Recognition in the Positive Airway Pressure Devices industry for its outstanding achievements in product innovation, clinical differentiation, and patient-centric therapy design. This recognition highlights SleepRes’ leadership in advancing measurable clinical […]
Panthera Dental announced a $13 million investment to expand its head office by 20,000 square feet, bringing the total size to 60,000 square feet and doubling its manufacturing capacity. The company specializes in the design and manufacturing of solutions for dental restorations, craniomaxillofacial surgeries, and the treatment of sleep-breathing disorders. “This […]
HoneyNaps, specializing in AI-powered sleep medical devices, has developed a next-generation wireless polysomnography system that combines patch-based skin sensors with artificial intelligence-driven analysis. Polysomnography (PSG) is the standard diagnostic test for sleep disorders such as sleep apnea. Conventional PSG, however, generally requires patients to spend a night at a hospital […]
Nyxoah SA announced that the first patient has been implanted in BREATHE, the Company’s U.S. post-approval study of the Genio® system. The procedure was performed by Rolando Molina, MD, otolaryngologist at South Florida ENT Associates. Edward Mezerhane, MD, FAASM, FACP, DABOM, CPI, sleep medicine physician at PharmaDev Clinical Research Institute […]
In a sleep management breakthrough, a University of Texas at Austin-led team of researchers has developed a noninvasive patch that boosts REM sleep in real-world trials without surgery or medication. The technology, called NEUSLeeP, is a soft, wearable device that uses gentle ultrasound waves and electrodes to stimulate deep brain […]
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 […]
Great Lakes Custom MARPE (Miniscrew-Assisted Rapid Palatal Expander) is customizable to meet the patient’s unique needs. The number and location of mini-screws required to achieve the desired expansion are specified by the doctor. Individualized appliance design and strategic mini-implant placement contribute to effective treatment. Great Lakes skilled technicians will provide […]
HoneyNaps, an AI-based sleep medicine company, announced that SOMNUM V3.0, its AI diagnosis software for polysomnography (PSG) analysis, has received U.S. Food and Drug Administration (FDA) clearance under clearance number K253390. SOMNUM is clinical decision support software designed to assist medical professionals in analyzing PSG data, including sleep staging and […]
Recently published study results demonstrate the efficacy of LivaNova Plc’s aura6000 System in treating moderate to severe obstructive sleep apnea (OSA). Published in Annals of Internal Medicine, the full 12-month results from the company’s OSPREY randomized controlled trial (RCT) demonstrate the safety and efficacy of proximal hypoglossal nerve stimulation (pHGNS), a differentiated neurostimulation modality. Overall, the study authors concluded that pHGNS for OSA yielded clinically significant improvements versus […]
