{"id":116992,"date":"2021-06-16T13:00:00","date_gmt":"2021-06-16T13:00:00","guid":{"rendered":"https:\/\/icrowdnewswire.com\/?p=28812792881279"},"modified":"2021-06-16T19:10:00","modified_gmt":"2021-06-16T19:10:00","slug":"n8-medicals-cerashield-endotracheal-tube-receives-health-canada-medical-device-license","status":"publish","type":"post","link":"https:\/\/ipsnews.net\/business\/2021\/06\/16\/n8-medicals-cerashield-endotracheal-tube-receives-health-canada-medical-device-license\/","title":{"rendered":"N8 Medical\u2019s CeraShield\u2122 Endotracheal Tube Receives Health Canada Medical Device License"},"content":{"rendered":"

Major Advance in Critical Care Medicine<\/em><\/strong><\/h3>\n

DUBLIN, OHIO [June 16, 2021] \u2014 N8 Medical (\u201cN8\u201d or the \u201cCompany\u201d) today announced that its CeraShield Endotracheal Tube (ETT) has been approved by Health Canada for a Medical Device License (\u201cMDL\u201d) for use in mechanically ventilated\u00a0 patients. N8 is the clinical stage,US based developer of the CeraShield platform technology for medical devices to prevent hospital acquired infections. The CeraShield ETT is its first product approved for use in Canada.<\/p>\n

The CeraShield ETT is designed to reduce the need for antibiotics and to reduce the risk of patients developing respiratory infections including a potentially fatal respiratory complication known as Ventilator Associated Pneumonia (\u201cVAP\u201d).\u00a0\u00a0 Although conventional ETTs are packaged as sterile, once the tube is inserted into the trachea it is rapidly fouled with bacterial biofilms which are impervious to antibiotic therapy.\u00a0 These biofilms act as a reservoir of endotoxin and\u00a0 infectious agents that can migrate to the patient\u2019s respiratory tract and cause infections and sepsis.\u00a0 Elderly patients and those with pre-existing neurocognitive decline are also at high risk of developing delirium, dementia and Alzheimer\u2019s following mechanical ventilation due to exposure to endotoxin which leads to inflammatory cytokine cascades and high levels of IL-6.<\/p>\n

Today\u2019s approval represents the first full regulatory approval for this device from a Tier 1 health care regulatory system.\u00a0\u00a0 The Canadian regulatory process is among the most stringent in the world and requires that sponsors of medical devices also obtain Medical Device Single Audit Program (MDSAP) certification as part of the approval process.<\/p>\n

Health Canada MDL approval will allow N8 to obtain near term regulatory approvals for the CeraShield ETT in other countries that recognize and follow Health Canada\u2019s regulatory approvals,\u00a0 N8 Medical is actively seeking distributors outside the US. \u00a0The CeraShield ETT is an investigational device in the United States and has been designated as a \u201cbreakthrough device\u201d by the United States Food & Drug Administration<\/p>\n

\u00a0<\/strong><\/p>\n

About N8 Medical<\/strong><\/p>\n

N8 Medical is a clinical stage US based developer of the CeraShield platform technology for medical devices to prevent hospital acquired infections. Frost & Sullivan previously awarded N8 its \u201cProduct Innovation of the Year Award\u201d for its platform CeraShield technology for medical devices.<\/p>\n

For more information, please visit \u00a0www.n8medical.com<\/a>\u00a0or contact\u00a0CarlGenberg@n8medical.com<\/a><\/p>\n

Contact Information:<\/strong><\/p>\n

Carl Genberg
\nCSO
\nN8 Medical LLC
\nDublin, Ohio 43017
\ncarlgenberg@N8Medical.com<\/a>
\n(614) 859-5740
\nwww.N8Medical.com<\/a><\/p>\n

The post N8 Medical\u2019s CeraShield™ Endotracheal Tube Receives Health Canada Medical Device License<\/a> appeared first on Financial Market Brief<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

Major Advance in Critical Care Medicine DUBLIN, OHIO [June 16, 2021] — N8 Medical (“N8” or the “Company”) today announced that its CeraShield Endotracheal Tube (ETT) has been approved by Health Canada for a Medical Device License (“MDL”) for use in mechanically ventilated  patients. N8 is the clinical stage,US based developer of the CeraShield platform […]<\/p>\n

The post N8 Medical’s CeraShield™ Endotracheal Tube Receives Health Canada Medical Device License<\/a> appeared first on Financial Market Brief<\/a>.<\/p>\n

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