StrokeViewer LVO includes a comprehensive set of tools with functionality to support the complete stroke workflow

FDA device

The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)

Dutch medtech NICO.LAB has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its StrokeViewer LVO, an intelligence algorithm for fast triaging of stroke patients.

The AI-powered powered solution facilitates the detection of image characteristics associated with a large vessel occlusion (LVO) and alerts physicians.

NICO.LAB has developed the StrokeViewer LVO to help physicians quickly deliver the right treatment to every stroke patient.

StrokeViewer LVO, which is already available in Australia and Europe, includes a comprehensive set of tools with functionality to support the complete stroke workflow.

The FDA approval was based on data from the multi-centre clinical study where the performance of the algorithm was retrospectively assessed in 384 patients from multiple US stroke centres.

According to the company, an expert panel evaluated the data to detect LVOs, including ICA, M1 and M2, and comparison with the algorithm demonstrated results that exceeded the performance goal.

The AI will be used by the cloud-based solution to better help physicians in the emergency stroke setting.

NICO.LAB’s LVO algorithm is embedded in a cloud-based system, which sends a notification to the medical specialists involved within minutes after a stroke patient arrives in the hospital.

The physicians can use their smartphones in the hospital and also at home to review the CT images in a web viewer and diagnose a stroke.

NICO.LAB CEO and co-founder Merel Boers said: “Medical specialists are under enormous pressure to make fast decisions day and night, but it’s not easy. Complicated assessment and interhospital communication sadly make life difficult for physicians motivated to treat stroke victims effectively.

“With our first FDA clearance we are now able to show U.S. physicians how impactful the combination of human and artificial intelligence is. And yes, more will follow as we are fully committed to unlocking the full healthcare potential for every patient.”

Earlier this month, Nanowear secured class II 510(k) clearance from the US FDA for its SimpleSENSE cloth-based diagnostic platform.