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FAQ: REMSleep's Expanded FDA Clearance for DeltaWave Nasal Pillow System
TL;DR
REMSleep's FDA clearance expansion gives the company a strategic advantage by opening institutional markets and reaching complex patient populations beyond traditional CPAP therapy.
The FDA expanded DeltaWave's 510(k) clearance to allow use in hospitals, sleep labs, and with various positive airway devices for broader patient conditions.
This expansion improves patient comfort and therapy access across care settings, potentially enhancing treatment outcomes for medically fragile populations with complex respiratory conditions.
REMSleep's DeltaWave nasal pillow system now serves patients with central sleep apnea, COPD, and heart failure in institutional settings based on customer feedback.
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REMSleep Holdings, Inc. received expanded FDA 510(k) clearance (K253939) for its DeltaWave nasal pillow system on January 15, 2026, significantly broadening its indicated use beyond home-based CPAP therapy.
The clearance expands DeltaWave's use in two ways: settings (now including hospitals, long-term care facilities, rehabilitation centers, and sleep labs) and patient populations/device modalities (covering all non-invasive positive airway devices for conditions like central sleep apnea, congestive heart failure, and COPD).
It addresses three strategic opportunities: opening institutional sales channels, allowing use in diagnostic titration settings in sleep labs, and serving complex patient populations who require more than traditional CPAP therapy.
Feedback from early adopters during REMSleep's Q4 2025 soft launch revealed that healthcare providers in various care settings wanted to use DeltaWave but were restricted by the original clearance's narrow language.
Sleep technicians, pulmonologists, respiratory therapists, and early adoption partners reported clinical need and barriers to adoption due to the original clearance's limitations.
Patients with central sleep apnea, complex sleep apnea, congestive heart failure, neuromuscular diseases, and COPD who require BiPAP or ventilation modalities beyond traditional CPAP therapy.
REMSleep submitted the supplemental 510(k) application in early December 2025 after consolidating feedback from early adoption partners.
DeltaWave's direct-flow technology and flexible pillow design address comfort issues that can lead to therapy abandonment in medically fragile populations who often experience mask fit challenges.
Sleep labs can now use DeltaWave during titration studies, allowing patients to experience the device during diagnostic sessions before going home, which addresses requests from lab technicians.
Curated from NewMediaWire
