Lung Bypass Device Gains Approval From Israeli Health Ministry

A cardiopulmonary bypass system developed by a Ra’anana-based startup has received medical devices and accessories (AMAR) approval from the Israeli Ministry of Health. 

The INSPIRA ART100, produced by Inspira Technologies, is designed for use during cardiac procedures lasting a maximum of six hours and is compatible with a range of other medical equipment. It uses advanced software and is portable so that it can be moved from patient to patient within a hospital.  

For the 400 million people with respiratory insufficiency, physicians offer supplemental treatments using devices like nasal cannula, a tube that supplies oxygen directly into the patients’ nose.

But when that isn’t enough, their only option is to induce coma and place patients on a mechanical ventilator, which is expensive, complex to use, and puts them at a high risk. Inspira wants its device to help reduce the reliance on mechanical ventilation. 

The announcement comes a month after the system received 510(k) approval from the US Food and Drug Administration (FDA) and can now be freely marketed in the United States.  

“As a physician and the head of the Israeli ECMO [Extra-Corporeal Membrane Oxygenation] Society, I am delighted to witness this exciting milestone where hospitals will have the opportunity to acquire and use the innovative and technologically cutting-edge INSPIRA™ ART100,” said Dr. Dekel Stavi, who is also Inspira’s medical director. 

Inspira CEO Dagi Ben-Noon said: “After we received FDA approval for the INSPIRA ART100 that will allow us to establish our presence in the US, receiving AMAR approval will facilitate the creation of business opportunities in new regions and emerging markets.”