SoClean Obtains FDA Clearance

PETERBOROUGH, N.H.--(BUSINESS WIRE)--Aug 20, 2024--

SoClean, a pioneer in bacterial reduction systems for CPAP hoses and masks, is pleased to announce it has been granted De Novo clearance by the FDA for the SoClean 3+. The SoClean 3+ is the only FDA cleared product intended to be used as an adjunct to reduce bacterial populations on certain compatible home use CPAP mask and ventilation hoses after cleaning. The SoClean 3+ has been demonstrated to achieve 99.9% bacterial reduction* in CPAP hoses and masks. SoClean is pleased to offer CPAP users this easy-to-use and convenient system to continually reduce bacterial build-up in CPAP hoses and masks.

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SoClean is committed to CPAP users and the clinical need to develop products that are easy to use and significantly reduce bacterial populations in CPAP hoses and masks. “Sleep apnea is a growing issue worldwide, which impacts user’s ability to get a proper night’s rest. Ensuring bacteria in CPAP hoses and masks can be easily reduced following cleaning is essential for daily use and maintenance by users,” says CEO Robert Wilkins. SoClean has over 150 patents issued worldwide focused on SoClean’s bacterial reduction systems, methods, devices and designs.

The SoClean 3+ is an over-the-counter device. It can be purchased online at www.soclean.com, once marketing commences. The SoClean 3+ is currently established for use with the ResMed Mirage FX (nasal mask), ResMed ClimateLine Air (tubing), and SlimLine (tubing) for the ResMed AirSense 10.** Moving forward, SoClean is working to establish additional hoses and masks for use with the SoClean 3+ bacterial reduction device.

SoClean is excited to introduce the SoClean 3+ home-use cleaning device for CPAP hoses and masks. SoClean will communicate to customers how to upgrade their current SoClean devices to a SoClean 3+ within the next 60 days. Additionally, SoClean will be offering an upgrade program to users of any other CPAP hose and mask cleaning devices. For additional information on these programs please visit ( www.soclean.com/upgrade ).

Questions regarding the SoClean 3+ for new or current users of SoClean devices should be addressed to info@soclean.com.

* The SoClean 3+ device is intended to be used as an adjunct to reduce bacterial populations on certain compatible home use CPAP mask and ventilation hoses after cleaning. An in vitro 3-log (99.9%) bacterial reduction by SoClean 3+ has been demonstrated for the following bacteria: Staphylococcus aureus (ATCC 6538), Klebsiella aerogenes (ATCC 13048), Staphylococcus haemolyticus (ATCC 29970), Escherichia coli (ATCC 11229), Staphylococcus hominis (ATCC 27844), Klebsiella pneumoniae (ATCC 4352), Pseudomonas aeruginosa (ATCC 15442), and Streptococcus pyogenes (ATCC 14289) after a complete processing cycle. Any correlation between in vitro results and clinical outcome has not been established.
The SoClean 3+ bacterial reduction device is an over-the-counter device for single patient home use. This device must not be used to replace the cleaning procedures as recommended by the CPAP mask and hose manufacturers. SoClean 3+ has been tested for use with ResMed Mirage FX (nasal mask), ResMed ClimateLine Air (tubing), and SlimLine (tubing) for ResMed AirSense 10 CPAP device. The safe use of SoClean 3+ with any other respiratory devices or accessories has not been established.

** SoClean is an independent company not affiliated with ResMed Inc. Names and associated trademarks are solely owned by the respective companies and manufacturers. Depictions of brand logos are for informational and educational purposes only and are used for customer equipment recognition.

SoClean 3+ Obtains FDA Clearance (Photo: Business Wire)

WASHINGTON (AP) — Top Biden administration officials on Thursday discussed the future of artificial intelligence at a meeting with a group of executives from OpenAI, Nvidia, Microsoft and other companies. The focus was on building data centers in the United States and the infrastructure needed to develop the technology.

White House press secretary Karine Jean-Pierre told reporters at the daily press briefing that the meeting focused on increasing public-private collaboration and the workforce and permitting needs of the industry. The computer power for the sector will likely depend on reliable access to electricity, so the utility companies Exelon and AES were also part of the meeting to discuss power grid needs.

The emergence of AI holds a mix of promise and peril: The automatically generated text, images, audio and video could help to increase economic productivity but it also has the potential to displace some workers. It also could serve as both a national security tool and a threat to guard against.

President Joe Biden last October signed an executive order to address the develop of the technology, seeking to establish protections through steps such as the watermarking of AI content and addressing consumer rights issues.

Attending the meeting for the administration were White House chief of staff Jeff Zients, National Economic Council Director Lael Brainard, national security adviser Jake Sullivan, deputy chief of staff Bruce Reed, Commerce Secretary Gina Raimondo and Energy Secretary Jennifer Granholm, among others.

Nvidia CEO Jensen Huang, OpenAI CEO Sam Altman, Alphabet President and Chief Investment Officer Ruth Porat, Meta Chief Operating Officer Javier Olivan, and Microsoft President and Vice Chairman Brad Smith were among the corporate attendees.

Matt Garman, the CEO of AWS, a subsidiary of Amazon, also attended. The company said in a statement that attendees discussed modernizing the nation's utility grid, expediting permits for new projects and ensuring that carbon-free energy projects are integrated into the grid.

White House press secretary Karine Jean-Pierre speaks during the daily briefing at the White House in Washington, Thursday, Sept. 12, 2024. (AP Photo/Jose Luis Magana)