Breath Diagnostics, Inc., a leader in breath-based molecular diagnostics, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its OneBreath™ platform.
The designation applies to OneBreath™ as an in vitro diagnostic device designed to assess exhaled volatile organic compounds (VOCs) from a single pre-operative breath sample.
It aims to support risk assessment in adult patients scheduled for elective cardiac surgery by identifying those at higher risk of postoperative pneumonia.
The FDA’s Breakthrough Device programme targets medical devices that may offer more effective treatment or diagnosis for life-threatening or severely disabling conditions.
Devices in the programme receive priority engagement with the FDA to support efficient development and review, while maintaining strict regulatory standards.
OneBreath™ uses a single-breath sampling method, analysed via liquid chromatography–mass spectrometry (LC-MS). The process takes around ten minutes, allowing easy integration into perioperative settings.
By measuring VOCs directly, the platform offers a non-invasive alternative to blood or other sample types, capturing multiple molecular signals to assess risk.
The device complements clinical evaluation and standard risk tools, does not detect specific pathogens, and is not intended to diagnose pneumonia. Testing is performed by qualified laboratory personnel and is for prescription use only.
Breath Diagnostics will continue collaborating with the FDA to advance OneBreath™ through regulatory pathways.
