Announcement • May 16
REMSleep Holdings, Inc. announced delayed 10-Q filing On 05/15/2026, REMSleep Holdings, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Mar 31
REMSleep Holdings, Inc. announced delayed annual 10-K filing On 03/30/2026, REMSleep Holdings, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Announcement • Jan 16
REMSleep Holdings, Inc. Receives Expanded FDA 510(k) Clearance for DeltaWave Nasal Pillow System REMSleep Holdings, Inc. announced receipt of expanded 510(k) clearance (K253939) from the U.S. Food and Drug Administration. The approval, granted January 15, 2026, significantly broadens DeltaWave's indicated use beyond home-based CPAP therapy to include institutional settings and a wider range of patient populations. The expanded clearance represents a direct response to feedback from early adopters during REMSleep's Fourth Quarter 2025 soft launch. Healthcare providers reported that patients in different care settings - hospitals, long-term care facilities, rehabilitation centers, and sleep labs - could benefit from DeltaWave but were restricted by the original clearance language. What changed: The original 510(k) clearance, granted in 2024, limited DeltaWave to home use with continuous positive airway pressure (CPAP) devices for obstructive sleep apnea treatment. The supplemental clearance expands the indicated use in two critical ways: Settings: DeltaWave is now cleared for use in hospitals, long-term care facility, rehabilitation centers, sleep laboratories, and other institutional environments for single-patient use. Customer-Driven Development: REMSleep submitted the supplemental 510(k) application in early December 2025 after consolidating feedback from early adoption partners. The feedback was consistent: the device was performing well clinically, but the narrow indicated use created barriers to broader adoption. Market Implications: The expanded clearance positions REMSleep to execute on all three channels outlined in the company's First Quarter 2026 strategy announced December 30: 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. Next steps: REMSleep will update marketing materials, sales training, and product labeling to reflect the expanded indicated use. The company is notifying existing partners and potential institutional customers about the expanded clearance. The expanded 510(k) clearance is publicly available in the FDA's 510(k) Premarket Notification database under device number K253939. 
