RA’ANANA, Israel, April 25, 2024 /PRNewswire/ — Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the “Company” or “Inspira”), a breakthrough medical technology company, announced that it has received the Canadian Standards Association (CSA) Certification of Compliance to U.S. standards for the INSPIRA ART100 device.
This is a positive recognition of our product’s quality and safety standards. We believe, subject to U.S. Food and Drug Administration (FDA) regulatory clearance, that this is an important milestone on the path towards attaining market access for our medical device, with the INSPIRA ART100 having undergone advanced testing and certification to evaluate compliance with safety and performance requirements defined by the CSA.
The Certification of Compliance allows for the INSPIRA ART100 System to bear the CSA Mark; C878081 MEDICAL ELECTRICAL EQUIPMENT/SYSTEMS – Certified to U.S. Standards.