www.fdanews.com/articles/208991-imspex-gets-ce-mark-for-breathspec-device
Imspex Gets CE Mark for BreathSpec Device
August 15, 2022
Imspex has received CE mark certification for its BreathSpec human breath analyzer for detection of COVID-19 infections.
The system uses a combination of gas chromatography and ion mobility spectrometry to identify volatile organic substances that are used as biomarkers for illness.
The equipment can be operated by a nonspecialist and can deliver results in a few minutes, the company said, adding that it can save on time and costs compared with polymerase chain reaction (PCR) testing.
Imspex aims to further develop breath-based testing as a “non-invasive way to address major healthcare challenges.”
The BreathSpec technology can also be used for measurement of drugs and their metabolites, and for assessing drug efficiency in pharmacokinetics.