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Articles

NIH Grant Funds Next Phase of Development for Seal-less PAP Device

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By PAP Devices
| Sleep Review Verified
Key takeaways: The NIH awarded a grant to support the development of a user-friendly, at-home version of the VortexPAP device. The device is currently utilized during overnight sleep studies administered by techs in clinical settings. Future testing goals include evaluating the device across multiple locations and longer periods to demonstrate everyday efficacy.
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CPAP Store USA Adds New Inogen Aurora CPAP Mask Line

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By PAP Devices
| Sleep Review Verified
Key takeaways: Inogen Inc has launched Aurora CPAP masks include the F1 Full Face, N1 Nasal Cushion, and P1 Nasal Pillows. CPAP Store USA is the first authorized online and in-store retailer to offer the Inogen CPAP mask line. The launch marks a notable expansion for both companies.
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FDA Issues Warning Letter Over APAPs

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By PAP Devices
| Sleep Review Verified
Key takeaways: The FDA issued a warning letter to BMC Medical regarding G3X APAP and Luna G3 APAP devices imported to the United States by React Health. The agency states the G3X APAP requires a new 510(k) clearance due to significant design, material, and firmware modifications from the previously cleared Luna system. The manufacturer was also cited for failing to report a firmware update initiated to fix an unexpected shutdown issue in Luna G3 APAP devices.
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