Dagi Ben Noon Inspira Technologies
Dagi Ben-Noon, CEO of Inspira Technologies and Dr. Benad Goldwasser, chair of the board of directors. [Image courtesy of Inspira Technologies]

Inspira Technologies (Nasdaq:IINN) announced that it submitted its Inspira ART100 cardio-pulmonary bypass device for FDA clearance.

Ra’anana, Israel-based Inspira designed the system to transform external breathing, empowering breathing without lungs. The company anticipates potential clearance for the system in the first half of 2024. ART100’s bid for 510(k) clearance is backed by a comprehensive usability study conducted in Boston, the company said.

Inspira developed its technology to revolutionize the medical ventilation and oxygenation market. Its next-generation treatment could reduce the reliance on external mechanical ventilation machinery.

The company’s flagship ART500 rapidly elevates blood oxygen saturation levels while keeping patients conscious and alert. It aims to provide advanced blood circulation technology while integrating AI-driven monitoring and analytics. Altogether, this could create patient-centric, data-driven solutions to enhance patient outcomes and optimize hospital efficiency.

“We are preparing for global deployments of our INSPIRA ART100 systems once FDA clearance is achieved,” Inspira Technologies CEO Dagi Ben-Noon said. “Our future systems can save millions of lives and change external respiratory aid for over 20 million people each year. We aim to be a part of this market over the next 5 years and are moving aggressively to achieve these goals.”