Medtronic announced Monday that as part of an agreement with Viz.ai, Medtronic will distribute clinical decision-support software designed to expedite stroke intervention. Financial terms of the deal were not disclosed.
Viz.ai, a startup backed by Google Ventures, licensed De Novo last year for its ContaCT app, which analyzes CT scans and flags suspected large vessel blockages via smartphone notifications, and within minutes A copy of the image was shared with a neurovascular specialist. A few months later, the startup received a 510(k) for additional CT perfusion scan image processing software. The company has not yet obtained a marketing license abroad.
Medtronic said its goal is to offer Viz.ai’s existing service at every U.S. stroke center, building on the more than 200 hospitals that have already adopted the technology.
According to a 10-year analysis recently published in the BMJ’s Journal of Neurointerventional Surgery, stroke is the fifth leading cause of death in the United States, and large vessel occlusion may be present in at least 30 percent of acute ischemic strokes. Medtronic already markets a stent that retrieves blood clots from blocked blood vessels to address such conditions.
While the FDA explicitly re-determined the link in February 2018, the tool was used only for notification purposes to indicate that the agency said faster treatment could reduce the severity or progression of stroke.
The FDA approval was backed up by a retrospective study of 300 CT images that compared Viz.ai’s algorithms to neuroradiologists’ expertise in detecting blockages in large blood vessels in the brain. “Real-world evidence was used in clinical studies that the app can notify neurovascular specialists early in the event of suspected obstruction,” the FDA said after De Novo’s statement.
At the time of approval review, Viz.ai said the median scan-to-notification time for apps was less than 6 minutes, and in more than 95 percent of cases, it said the software saved an average of less than professionals deciding to notify providers of suspicious risks 52 minutes.
Medtronic has incorporated artificial intelligence into its diabetes unit. Its Sugar.IQ tool works with a continuous glucose monitor, leveraging IBM Watson Health’s AI to analyze how glucose levels respond to factors such as food intake and insulin dose. Likewise, Medtronic last November acquired Nutrino, which uses AI to predict how nutrition affects blood sugar.