FDA Expands DeltaWave Nasal Pillow Use for Complex Sleep Apnea Cases
REMSleep Holdings, Inc. has secured expanded FDA clearance for its DeltaWave nasal pillow system. The approval, granted on January 15, 2026, now allows the device to be used with a broader range of patients. This includes those with complex conditions such as central sleep apnea, congestive heart failure, and COPD.
The company first submitted its supplemental 510(k) application in early December 2025. This followed feedback from early adoption partners who saw potential in wider applications. The original clearance had restricted DeltaWave to home use with CPAP devices for obstructive sleep apnea only.
The expanded 510(k) clearance, listed under device number K253939 in the FDA database, now covers institutional settings. Hospitals, long-term care facilities, and sleep laboratories can integrate the system into patient care. The update also aligns with REMSleep’s Q1 2026 strategy, opening new avenues for DME/HME providers and sales teams. Three key opportunities emerge from this clearance. It enables institutional sales channels, supports sleep laboratory use, and serves more complex patient groups. Conditions like neuromuscular diseases and mixed sleep apnea are now within the device’s approved scope.
The expanded clearance widens DeltaWave’s reach beyond home CPAP treatment. Healthcare providers can now deploy the system in clinical and long-term care environments. This move follows REMSleep’s strategic push to address unmet needs in sleep therapy for high-risk patients.
