REMSleep’s DeltaWave cleared for broadened indicated use 

BLACKSHEAR, Ga. - REMSleep Holdings, developer of the DeltaWave nasal pillow system, has received expanded 510(k) clearance from the U.S. Food and Drug Administration (FDA). 

The approval, granted Jan. 15, 2026, significantly broadens DeltaWave’s indicated use beyond home-based CPAP therapy to include institutional settings and a wider range of patient populations. 

“Our customers told us they were seeing patients who needed what DeltaWave offers but couldn’t access it because of how narrowly we’d written the original 510(k),” said Thomas Wood, CEO and founder of REMSleep. “Sleep technicians, pulmonologists and respiratory therapists work with these patients every day. When they tell us there’s a clinical need, we listen.” 

REMSleep soft-launched DeltaWave in the fourth quarter of 2025. 

The original 510(k) clearance, granted in 2024, limited DeltaWave to home use with CPAP devices for obstructive sleep apnea (OSA) treatment. The supplemental clearance expands the indicated use in two ways:  

• Settings: DeltaWave is now cleared for use in hospitals, long-term care facilities, rehabilitation centers, sleep laboratories and other institutional environments for single-patient use. Previously restricted to home care settings only.  
• Patient populations and device modalities: The expanded clearance covers use with all non-invasive positive airway devices. This opens DeltaWave to patients with central sleep apnea, complex sleep apnea, congestive heart failure, neuromuscular diseases, and COPD – conditions requiring more modalities and therapy than traditional CPAP. 

The expanded clearance positions REMSleep to execute on three channels:  

• DME/HME providers can now position DeltaWave as a rescue mask for patients failing traditional interfaces across all pressure modalities, not just CPAP. 
• Sleep laboratories and pulmonologists can introduce patients to DeltaWave during diagnostic titration, creating brand preference before patients enter the home care channel. 
• Institutional sales teams can now approach hospital respiratory departments, long-term care facilities, and rehabilitation centers with a device cleared for their patient populations and care environments. 

“The timing is deliberate,” Marshall said. “We spent Q4 building infrastructure – sales force, inventory systems, replacement parts. Now we have the regulatory clearance to support the full strategy. Everything’s aligned.” 

• Related: REMSleep hires Stelzner, prepares for DeltaWave push.