REMSleep Receives Expanded FDA 510(k) Clearance for DeltaWave Nasal Pillow System [Yahoo! Finance]
REMSLEEP HOLDINGS INC (RMSL)
NASDAQ:AMEX Investor Relations:
marketwired.com/press-release/remsleep-holdings-inc-announces-launch-of-new-corporate-website-otc-pink-bvigd-2006418.htm
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Source: Yahoo! Finance
BLACKSHEAR, GA - January 15, 2026 ( NEWMEDIAWIRE ) - REMSleep Holdings, Inc. (OTCQB: RMSL), developer of the FDA-cleared DeltaWave(TM) nasal pillow system, today 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 Q4 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. "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
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