Summary: Inspira Technologies received FDA 510(k) class II clearance for its Inspira Art100 cardiopulmonary bypass system. This technology elevates patient oxygen levels quickly, potentially reducing the need for mechanical ventilation. Other Inspira products are still awaiting regulatory approval.

Key Takeaways:

  • FDA Clearance: Inspira Art100 cardiopulmonary bypass system received FDA 510(k) class II clearance.
  • Technological Advancements: The system quickly elevates oxygen saturation levels, potentially reducing the need for mechanical ventilation.

Inspira Technologies announced that it has received notification of 510(k) class II clearance from the U.S. Food and Drug Administration (FDA) for its Inspira Art100, a cardiopulmonary bypass system.

“This is a proud moment for all of us at Inspira Technologies,” said Dagi Ben Noon, CEO of Inspira. “We would like to thank all our investors and partners who have been with us on this journey to get here.”

Life-Support Technology

Inspira Technologies is a life support medical technology company. The Inspira Art (Gen 2), also known as the Inspira Art500, includes 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 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 comas.

Future Product Development

The company’s 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.

“We believe that the FDA clearance marks a clear example of the company’s technological and innovative advancements,” said Benad Goldwasser, the chairman of the board of Inspira.