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REMSleep’s DeltaWave cleared for broadened indicated use 

January 19, 2026HME News Staff

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...

DeltaWave, FDA clearance, nasal pillow system, RemSleep

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