sets its sights across the pond with CE mark for stroke-detecting AI

With a recent influx of more than $70 million in a series C financing and, now, a shiny new CE mark for its stroke-spotting artificial intelligence software, is ready to take its talents to Europe.

Previously cleared only in the U.S., the Viz LVO platform will now begin rolling out in the E.U., where strokes are the second leading cause of death, according to the company.

The software uses artificial intelligence to read CT angiography imaging data and identify signs of large vessel occlusions, a type of ischemic stroke where one of the main arteries of the brain is blocked by a blood clot.

Once a clot is detected, Viz LVO automatically issues an alert to on-call stroke specialists for further review. The alert can be sent directly to the specialists’ smartphones, where they can review the images and communicate with the rest of their facility’s stroke team via secure texts and calls on the HIPAA-compliant platform.

RELATED: Medtronic to distribute's stroke-spotting AI imaging software

On average, the software takes less than six minutes to spot a potential stroke and send out the alert, according to the company. received a de novo clearance from the FDA in February 2018 for Viz LVO, which was then known as Viz ContaCT. The clearance came after a study proved that the AI could detect and triage suspected blockages in the brain faster than trained neuroradiologists.

Since then, an even larger study—analyzing imaging data of more than 2,500 patients from 139 hospitals—demonstrated the software’s 96% sensitivity and 94% specificity in identifying large vessel occlusions.

RELATED: Stroke-spotting software maker raises $71M to expand clinical reach

The company has also received two subsequent FDA clearances for its other software solutions. Viz CTP, which was cleared just a few months after Viz LVO, helps healthcare providers view and analyze CT perfusion images. It can be used in tandem with Viz LVO to speed up the time-sensitive process of confirming the presence of a blood clot in one of the brain’s arteries.

And in 2020, received its third FDA OK, this one for Viz ICH. Similar to Viz LVO, this software uses AI to analyze CT scans for evidence of intracranial hemorrhage. Once spotted, the AI sends an automated alert to the medical facility’s stroke team through the same HIPAA-compliant mobile platform.

Earlier this year, closed a series C round that brought in a total of $71 million in new funding. It was co-led by Scale Venture Partners and Insight Partners, and also included Greenoaks, Kleiner Perkins, Threshold Ventures, CRV, Innovation Endeavors and Susa Ventures.

At the time, the company noted that it was working on making its software available throughout the U.S. and Europe—mission accomplished, thanks to Viz LVO’s new CE mark—and said it would use the financing to expand its AI into other areas beyond stroke treatment, such as cardiovascular, pulmonary and trauma care.