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System is cleared in the U.S. for cardiopulmonary bypass procedures and Israel for extra-corporeal membrane oxygenation and cardiopulmonary bypass procedures.
August 16, 2024
By: Michael Barbella
Managing Editor
Inspira Technologies OXY B.H.N. Ltd. has gained Israeli Ministry of Health medical devices and accessories (AMAR) approval for the INSPIRA ART100, an extra-corporeal membrane oxygenation and cardiopulmonary bypass system. “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,” said Inspira Medical Director Dr. Dekel Stavi, who is also head of the Israeli Extra-Corporeal Membrane Oxygenation (ECMO) Society. “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,” Inspira Technologies CEO Dagi Ben-Noon stated. Inspira Technologies develops expanding life support technologies and solutions to prolong life and improve patients’ quality of life. The company’s INSPIRA ART100 system received U.S. Food and Drug Administration 510(k) clearance for cardiopulmonary bypass procedures and AMAR certification for extra corporeal membrane oxygenation and cardiopulmonary bypass procedures. Inspira Technologies’ other products, including the INSPIRA ART (Gen 2) and HYLA blood sensor, have not yet been tested or used in humans and have not been approved by any regulatory entity. The INSPIRA ART (Gen 2), also known as the INSPIRA ART500, will include the company’s Adaptive Blood Oxygenation technology and is being designed to continuously measure the patient’s blood parameters in real-time, delivering needed oxygen volume straight into the blood. By elevating patient oxygen saturation levels in minutes, this technology potentially allows patients to remain awake during treatment and therefore may enable patients to be treated in and beyond intensive care units, reducing the need for mechanical ventilation systems that require intubation and medically induced coma.
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