A cardiopulmonary bypass system developed by an Israeli startup has received 510(k) approval from the US Food and Drug Administration (FDA).
The FDA says that 510(k) approval means that a device has undergone a comprehensive review of safety and performance data to determine if it is substantially equivalent to a device that is already on the market. Once a device has been given 510(k) approval, it can be freely marketed in the United States.
The INSPIRA ART100, produced by Inspira Technologies, uses advanced software and is portable so that it can be moved from patient to patient within a hospital. It designed for use during cardiac procedures lasting a maximum of six hours and is compatible with a range of other medical equipment.
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.
“This is a proud moment for all of us at Inspira Technologies. We would like to thank all our investors and partners who have been with us on this journey to get here,” said Inspira CEO Dagi Ben Noon.
“We believe that the FDA clearance marks a clear example of the Company’s technological and innovative advancements,” said Inspira Chairman of the Board Professor Benad Goldwasser.
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