Summary: REMSleep Holdings Inc announced a goal to capture 10% of the CPAP mask market within the next 24 months following the FDA approval of its DeltaWave nasal pillow mask. The company’s CEO says REMSleep aims to improve CPAP therapy compliance by addressing mask discomfort, a … [Read more...]
FDA Seeks Input on Advancing Health Equity in Medical Devices
Summary: The FDA’s Center for Devices and Radiological Health (CDRH) has published a discussion paper titled “Health Equity for Medical Devices” and is seeking public input to advance health equity in the medical device sector. The paper outlines considerations for designing … [Read more...]
Alice-Compatible Consumables Comparison Guide | Sleep Review
With Philips’ departure from the sleep diagnostics space earlier this year, sleep disorders centers may find themselves in a lurch concerning replacement parts for the Alice line of diagnostics equipment, including Alice 6, Alice NightOne, and Alice PDx. Shipments of these … [Read more...]
Movano Continues to Pursue FDA Clearance for EvieMED Ring
Summary: Movano Health is working toward securing a 510(k) clearance from the FDA for its EvieMED Ring, a wearable device that combines medical functionality through pulse oximetry with wellness metrics related to sleep, activity, and mood/energy/symptom logging. After filing an … [Read more...]
Sleep Difficulties Linked to Suicidal Thoughts in At-Risk Adolescents
Summary: A recent study led by Rebecca Robbins, PhD, from Brigham and Women’s Hospital, explores the relationship between sleep difficulties, substance abuse, and suicidal ideation in adolescents with a history of depression. Using data from the National Surveys of Drug Use and … [Read more...]
FDA Approves Next-Gen Inspire Therapy System for OSA
Summary: Inspire Medical Systems announced it has received FDA approval for its next-generation Inspire V therapy system, which includes a new neurostimulator and Bluetooth-enabled patient remote and physician programmer. The company is preparing for a commercial launch in the … [Read more...]
Xywav Helps Propel Jazz to Over $1 Billion in Q2 Revenues
Summary: Jazz Pharmaceuticals reported record revenues exceeding $1 billion for Q2 2024, driven by strong sales of Xywav in its sleep medicine portfolio, as well as Epidiolex and Rylaze in its seizure and oncology portfolios. The company saw a 13% year-over-year increase in Xywav … [Read more...]
ResMed Q4 Revenue Growth Driven by Increased Demand for Sleep Devices and Software Solutions
Summary: ResMed Inc announced its fourth-quarter results, reporting a 10% revenue growth on a constant currency basis, driven by increased demand for its sleep devices, masks, and Software as a Service (SaaS) business. Mick Farrell, chairman and CEO, emphasized the company’s … [Read more...]
Vanda Highlights Q2 Efforts to Expand Hetlioz Amid Regulatory and Market Challenges
Summary: Vanda Pharmaceuticals reported its second-quarter 2024 financial and operational results, emphasizing efforts to expand the use of Hetlioz (tasimelteon) for pediatric insomnia and jet lag disorder. The company notes its financial performance was impacted by generic … [Read more...]
First Patient Dosed in Phase 3 Study of Lumryz for IH
Summary: Avadel Pharmaceuticals has commenced dosing in the REVITALYZ phase 3 study to evaluate the efficacy and safety of Lumryz, an extended-release sodium oxybate, as a treatment for idiopathic hypersomnia (IH). The study, involving approximately 150 adults, aims to assess the … [Read more...]
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