The nasal pillow interface aims to enhance user comfort and maintain natural breathing patterns.
RT’s Three Key Takeaways:
- FDA Clearance: REMSleep Holdings Inc’s DeltaWave nasal pillow CPAP mask has been granted 510(K) clearance.
- Design Features: The DeltaWave mask focuses on user comfort and natural breathing, utilizing fluid dynamics to ensure adequate airflow and low resistance to exhalation.
- Market Preparation: REMSleep Holdings is preparing for the market launch by updating its website, ordering inventory, and coordinating with potential distributors, with pre-orders expected to begin soon.
REMSleep Holdings Inc has been granted 510(K) clearance for its DeltaWave nasal pillow CPAP interface mask.
The DeltaWave is designed to provide comfort and breathing ability. As uncomfortable masks may be one of the reasons patients discontinue their therapy, the DeltaWave nasal pillow interface employs fluid dynamics to ensure each breath has adequate airflow to satisfy demand, allowing users to breathe at their normal respiratory rate with no mechanical interruption.
In addition to supporting breathing rate with no noticeable resistance to exhalation, other features of the DeltaWave include low noise, one simple and loose-fitting head strap, and less or sometimes no need for humidification, according to the company’s website.
The company will begin preparing the DeltaWave CPAP mask for market. This preparation includes updating the website, ordering large inventory, corresponding with potential distributors, and handling all other marketing areas.
REMSleep Holdings expects to begin accepting pre-orders soon.
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