Today's decision does more than just allow Viz.AI Contact to be marketed: It sets a standard for future software of its kind.
The US Food and Drug Administration announced this afternoon that it has approved Viz.AI’s Contact application for marketing.
The software is a clinical decision support tool that uses artificial intelligence (AI) to analyze CT imaging for indications of stroke. If a suspected large vessel blockage is identified, the algorithm will automatically send a text notification to a neurovascular specialist.
Viz.AI submitted a retrospective study of 300 CT images to prove the performance of its algorithm. The software’s diagnostic capability performed favorable when compared to that of 2 trained neuro-radiologists, and the FDA’s announcement notes that the application could potentially notify a neurovascular specialist sooner in cases where a blockage was suspected.
“The software device could benefit patients by notifying a specialist earlier thereby decreasing the time to treatment. Faster treatment may lessen the extent or progression of a stroke,” said Robert Ochs, PhD, said in the announcement. Ochs is the acting deputy director for radiological health, Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
Despite the software’s capabilities, it only notifies the specialist, who will still need to analyze the images to confirm a stroke diagnosis.
The marketing approval comes via the agency’s de novo premarket pathway for medical devices that are considered low-to-moderate risk. In the FDA’s official announcement of the software’s approval, it notes that it is currently working to create a definitive regulatory framework for algorithm-based decision support devices.
The approval of Viz.AI Contact, however, establishes a precedent. Today’s decision “creates a new regulatory classification,” according to the FDA, meaning that “subsequent computer-aided triage software devices with the same medical imaging intended use may go through the FDA’s premarket notification (510 (k)) process.”