Inspira Technologies OXY is seeking approval for its INSPIRA ART100 device, which is intended for patients undergoing cardiopulmonary bypass procedures, to enter the South-East Asia and South American markets.

The company submitted an application for the device to AMAR, the Israeli Ministry of Health's medical device regulation unit.

The INSPIRA ART100 device is designed for use in an extracorporeal perfusion circuit for pumping blood during short-duration cardiopulmonary bypass procedures that last six hours or less.

It features non-invasive HYLA blood sensor technology, which is designed to carry out continuous blood measurements in real-time.

Additional features of the device include a large touchscreen and colourful graphical representation to enhance the visibility, scope and functionality of data presented to the medical staff.

Inspira Technologies CEO Dagi Ben-Noon said: “We are immensely proud to submit our initial blood oxygenation device, the INSPIRA ART100 for AMAR approval, ahead of our INSPIRA ART (Gen 2) device designed to treat patients while awake without the need for mechanical ventilation, marking a pivotal moment in our mission to redefine life support on a global scale.

“The enthusiastic support from local key-opinion leaders highlights the excitement surrounding our technology, setting the stage for its global journey. Our team has blended advanced engineering, technology, and design to push the boundaries.”

In August 2023, Inspira completed a usability study for its INSPIRA ART100 device in Boston, Massachusetts, US.

The study involved assessing and examining the device in a setting designed to consider the human aspects of the intended users, uses and use environments.

Inspira is focused on the development of medical technologies and products for the prevention of mechanical ventilation.