The Magazine for Sleep Professionals
Saturday, September 26, 2026
Onera Health announces that the quality management system of its legal manufacturing subsidiary, Onera B.V., has been certified to meet the requirements of MDR (EU) 2017/745 regulation (Annex IX, chapter I and III).. The Onera STS 2 system, which will be marketed as part of the Onera hPSG® solution, falls within […]
Iranian National residing in Coos Bay pleaded guilty today to conspiracy to commit healthcare fraud. Mehrdad Gerami, Age 67, pleaded guilty to conspiracy to commit healthcare fraud. According to court documents, from 2021 to the present, Gerami was the owner and operator of Coastal Diagnostic Testing Group (CDTG). CDTG operates […]
Cathay Capital announced the launch of ReDream Brands, a new consumer sleep health platform dedicated to helping millions of people achieve better sleep and healthier lives. The platform brings together four of the industry’s most recognized direct-to-consumer brands: cpap.com, The CPAP Shop, Lofta and sleeping.com, creating a leading platform for […]
CND Life Sciences announced the completion of growth financing led by S-Curve Partners, an operator-led healthcare investment firm focused on founder-inspired healthcare technology and diagnostics businesses. S-Curve was joined by current CND investors and shareholders, reflecting continued confidence in the Company’s commercial trajectory, expanding clinical adoption, and long-term strategic positioning. […]
Takeda announced that the U.S. Food and Drug Administration (FDA) approved ORZEYFUL™ (oveporexton), an oral orexin receptor 2 (OX2R) agonist, for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults.* The persistent 24-hour nature of NT1 is driven by orexin deficiency and can severely impact people’s lives. […]
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 […]
Takeda China announced that the National Medical Products Administration of China has approved the use of ORZEYFUL (oveporexton) for the treatment of narcolepsy type 1 (NT1) in adolescents aged 16 years and older and adults. Oveporexton is the first oral orexin receptor 2 (OX2R)-selective agonist approved in China and is the […]
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 […]
