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REMSleep's DeltaWave Gets FDA Green Light for Hospitals & Complex Patients

REMSleep receives expanded FDA clearance for DeltaWave nasal pillow system, enabling use in hospitals and for complex patients with heart failure, COPD & neuromuscular diseases.

This expanded FDA clearance matters because it directly addresses critical gaps in sleep apnea and respiratory care. For millions of patients with complex conditions like congestive heart failure, COPD, or neuromuscular diseases who require BiPAP or ventilation therapy, mask discomfort is a leading cause of therapy abandonment, which can worsen health outcomes and increase healthcare costs. By making DeltaWave available in institutional settings and for these broader patient populations, healthcare providers gain a valuable tool to improve therapy compliance. This development could lead to better managed chronic conditions, reduced hospital readmissions, and improved quality of life for vulnerable patient groups who have historically struggled with traditional mask interfaces.