Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in FierceHealthcare, in “FDA Approves AI Stroke Application, Signaling a Shift in Triage Software Oversight,” by Evan Sweeney.

Following is an excerpt:

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. …

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.” …

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.

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