INSPIRA ART100 Gets Green Light from Israeli Regulators

Inspira Technologies OXY B.H.N. Ltd. has secured approval from the Israeli Ministry of Health (AMAR) for its INSPIRA ART100 system, designed for extracorporeal membrane oxygenation and cardiopulmonary bypass procedures.

Inspira Medical Director Dr. Dekel Stavi, head of the Israeli Extra-Corporeal Membrane Oxygenation (ECMO) Society remarked, "As a physician and the head of the Israeli ECMO Society, I am delighted to witness this exciting milestone where hospitals will have the opportunity to acquire and use the technologically cutting-edge INSPIRA ART100.”

"After we received FDA approval for the INSPIRA ART100 that will allow us to establish our presence in the U.S., receiving AMAR approval will facilitate the creation of business opportunities in new regions and emerging markets," Dagi Ben-Noon, Inspira Technologies CEO mentioned.

Inspira Technologies is advancing its mission to enhance patient care with its innovative life support technologies. The company recently achieved a significant milestone as its INSPIRA ART100 system received 510(k) clearance from the U.S. Food and Drug Administration (FDA), allowing its use in cardiopulmonary bypass procedures. Additionally, the system has obtained AMAR certification, further validating its application in extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass procedures.

While the INSPIRA ART100 moves forward with regulatory approvals, other products in Inspira's pipeline, such as the INSPIRA ART (Gen 2) and the HYLA blood sensor, are still under development. These devices have not yet undergone human testing or received approval from regulatory bodies. The upcoming INSPIRA ART (Gen 2), also referred to as the INSPIRA ART500, is designed to incorporate Adaptive Blood Oxygenation technology. This technology aims to continuously monitor blood parameters in real-time, ensuring precise oxygen delivery directly into the bloodstream.

This next-generation system holds promise for revolutionizing patient care by elevating blood oxygen levels swiftly, potentially allowing patients to remain conscious during treatment. Such a capability could extend treatment beyond intensive care units, minimizing the reliance on mechanical ventilation systems that require intubation and sedation.