FDA approves AI stroke application, signaling a shift in triage software oversight

FDA sign
Attorney Bradley Merrill Thompson says the FDA's latest approval shows the agency "seems to be warming to artificial intelligence used for triage." (FDA)

The Food and Drug Administration (FDA) approved an application that uses artificial intelligence to alert physicians of a potential stroke, signaling a notable shift in the way the agency reviews clinical decision support software used for triage.

The application, called Viz.AI Contact, uses an AI algorithm to analyze computed tomography (CT) scans and identify signs of a stroke in patients. The application notifies a neurovascular specialist via smartphone or tablet when it has identified a potential blockage in the brain, reducing the time it takes for a specialty provider to review the scans.

“Faster treatment may lessen the extent or progression of a stroke,” Robert Ochs, Ph.D., acting deputy director for radiological health at the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in an announcement. The FDA noted that the app is not intended as a replacement for a full patient evaluation.

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While the approval aligns with the FDA’s longstanding comfort with image-based AI software, it’s also a departure from 2012 guidance that categorizes triage-based software as a higher risk functionality. In that regard, the approval goes farther than what the FDA has cleared in the past, which is a “big deal,” Bradley Merrill Thompson, an attorney with Epstein Becker & Green, said in an email to FierceHealthcare.

“[Triage] issues have been discussed for quite some time, so this is a big deal at least with regard to stroke,” he says. “But more generally, FDA seems to be warming to artificial intelligence used for triage which many companies will find is very good news.”

The app was cleared through the De Novo premarket review pathway, which oversees new devices that have been deemed a low to moderate risk. The approval also creates a new regulatory classification, allowing “subsequent computer-aided triage software devices with the same medical imaging intended use” to seek clearance through the premarket 510(k) processes.

It also comes at a time when the FDA is establishing a long-awaited regulatory framework for CDS software. The agency’s guidance, released in December, has drawn criticism from several health IT groups, including the CDS Coalition, led by Thompson, which said the guidance would lead to patient harm and force vendors to pull products off the market.