The designation applies to OneBreath™ as an in vitro diagnostic intended for the qualitative assessment of exhaled volatile organic compounds (VOCs) from a single pre-operative breath specimen. The test is designed to aid in perioperative risk stratification and management of adult patients scheduled for elective cardiac surgery by identifying those at elevated risk of developing postoperative pneumonia (POP).

The FDA grants Breakthrough Device designation to a limited set of qualifying medical devices that have the potential to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases than current options. Devices accepted into the program receive prioritized FDA interaction and enhanced communication to support more efficient development and review, with the goal of providing patients and healthcare providers more timely access to innovative technologies while maintaining the FDA’s rigorous standards. This Breakthrough Device Designation is based on evidence demonstrating that OneBreath™ has the potential to identify patients at elevated risk of developing postoperative pneumonia through qualitative molecular analysis of exhaled breath.