Inspira™ Technologies Announces FDA 510(k) Submission of INSPIRA™ ART100
Thursday, September 14, 2023
Inspira™ Technologies has announced that it has submitted its INSPIRA ART 100 cardio-pulmonary bypass device to the U.S. Food and Drug Administration (FDA) through the 510(k) pathway.
The INSPIRA™ ART500 is an advanced device with a focus on rapidly increasing blood oxygen saturation levels while allowing patients to remain conscious and alert. This is a significant improvement compared to traditional methods of oxygenation, which may require patients to be sedated or even put on mechanical ventilation.
Traditional ventilation and oxygenation methods can indeed lead to complications, including physical damage, infection, and even death in some cases. If the INSPIRA devices can address these issues effectively and receive FDA approval, they could significantly improve the quality of care for patients requiring external breathing assistance.
The submission of INSPIRA ART 100 to the FDA follows a comprehensive usability study conducted in Boston, Massachusetts. Such studies are crucial to ensuring that medical devices are safe and effective for use in clinical settings. The expected approval timeline for this submission is approximately six months, with a targeted approval set for the first half of 2024.