RESPINOR DXT has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for monitoring diaphragm movement on adult patients in the ICU and identifying patients at increased risk of extubation failure during the weaning process from mechanical ventilation.

The FDA’s Breakthrough Devices Program is designated by the FDA to products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The Breakthrough Devices Program is intended to provide patients and healthcare providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization.

The Breakthrough Device designation for RESPINOR DXT underscores its potential to provide non-invasive, continuous monitoring of the diaphragm for critically ill patients in the ICU on Mechanical Ventilation, identify those at increased risk of reintubation, and thereby reduce the risk of associated morbidities and mortality associated with mechanical ventilation, as well as the ICU and hospital length of stay.

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