UpFront Diagnostics secures CE mark for LVOne stroke test
UpFront Diagnostics has received CE mark approval for LVOne, a rapid blood-based diagnostic device designed to support early stroke detection, including large vessel occlusion (LVO) stroke.
The approval enables the company to commercialise LVOne across the European Union and confirms that the device meets applicable European safety, health and environmental requirements.
According to UpFront Diagnostics, LVOne is the first blood test-based stroke diagnostic in-vitro diagnostic device to receive CE mark approval.
The portable test is designed for use by paramedics and emergency teams at the point of care.
It uses stroke-related biomarkers to provide an objective result and support faster assessment before patients reach hospital.
LVOne is intended to help emergency teams identify patients who may require specialist treatment, including thrombectomy.
Earlier identification could support faster transfer to specialist stroke centres and help reduce delays between initial assessment and treatment.
The device is also UKCA marked and is currently being piloted with the London Ambulance Service.
UpFront Diagnostics holds ISO 13485:2016 certification covering the design, development, manufacture and distribution of LVOne.
The CE mark represents a key regulatory milestone for the company as it prepares to expand the availability of its portable stroke diagnostic technology across Europe and support pre-hospital stroke assessment.
