FDA announced last week that it has cleared for marketing an mHealth app that uses artificial intelligence (AI) to analyze CT images for signs of stroke. The app, called Contact, is a clinical decision support tool marketed by Viz.AI. It relies on triage software to scan for potential blockages and then notifies a medical specialist via smartphone or tablet. The anticipated benefit is that quicker identification of blockages will decrease the time to treatment and improve outcomes.

FDA’s press release provides helpful detail for developers regarding how Viz.AI substantiated the efficacy of its app. “The company submitted a retrospective study of 300 CT images that assessed the independent performance of the image analysis algorithm and notification functionality of the Viz.AI Contact application against the performance of two trained neuro-radiologists for the detection of large vessel blockages in the brain. Real-world evidence was used with a clinical study to demonstrate that the application could notify a neurovascular specialist sooner in cases where a blockage was suspected.”

The pathway to clearance was also unique. As also noted in the press release, “The Viz.AI Contact application was reviewed through the De Novo premarket review pathway, a regulatory pathway for some new types of medical devices that are low to moderate risk and have no legally marketed predicate device to base a determination of substantial equivalence. This action also creates a new regulatory classification, which means 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, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.”

This announcement is welcome news, particularly in light of FDA’s late 2017 Clinical Decision Support guidance, which has been met with frustration by some in industry. It also follows earlier mhealth innovations specific to stroke treatment, which may provide important tools to hospitals with limited resources or access to neurological specialists.