PRiME: non-invasive monitoring of premature infants
Provida Medical, Oslo University Hospital and Finnish technology partners · 2022–2024
The project examined whether volatile organic compounds (VOCs) in the ventilator air can be used to detect infection and complications in extremely premature infants, without the equipment touching the patient or changing the ward's routines.
I was the commercial project owner and lead author of the technical description: system design, the regulatory assessment of prototype use without CE marking, a risk assessment across five risk areas, and a data handling regime in which no data leaves the hospital and the patient cannot be identified from the data set.
The project received approval from REK, the Regional Committee for Medical and Health Research Ethics, to begin first clinical testing in neonatal intensive care.
