FDA OKs mHealth App That Uses AI to Spot Strokes, Alert Specialists

Federal regulators have approved an mHealth app that uses artificial intelligence to analyze CT images for signs of a stroke, potentially speeding up the time to treatment.

The U.S. Food and Drug Administration has cleared for marketing the Contact app from Viz.AI, a San Francisco-bases startup that bills its mobile health tool as a direct-to-intervention system. The app uses computer-aided triage software to search for large vessel occlusions in brain CTs, then sends a text message to a neurovascular specialist.

"The software device could benefit patients by notifying a specialist earlier thereby decreasing the time to treatment,” Robert Ochs, PhD, acting deputy director for radiological health in the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health, said in a statement. “Faster treatment may lessen the extent or progression of a stroke.”

“The Viz.AI Contact application is a computer-aided triage software that uses an artificial intelligence algorithm to analyze images for indicators associated with a stroke,” the FDA reported in its release. “Artificial intelligence algorithms are a type of clinical decision support software that can assist providers in identifying the most appropriate treatment plan for a patient’s disease or condition. The FDA is currently creating a regulatory framework for these products that encourages developers to create, adapt and expand the functionalities of their software to aid providers in diagnosing and treating diseases and conditions.”

The app is the latest in a line of telehealth and mobile health tools and platforms designed to improve the detection of strokes in the field and speed up time to life-saving treatment. The advances include specially-designed mobile units that can begin treatment when dispatched to the patient’s location and telestroke platforms that connect healthcare providers through telemedicine to neurologists no matter where they’re located.

“Particularly in hospitals with limited local resources and/or limited access to neurologic expertise, telestroke is an important tool to aid in the evaluation and treatment of potential stroke,” researchers with Kaiser Permanente reported in a landmark 2016 study that showed a 75 percent increase in timely use of the clot-busting drug Tissue Plasminogen Activator (tPA) following a telemedicine consult. “We specifically found that unwarranted hospital variability in stroke care could be eliminated through a standardized telestroke program. Additionally, telestroke may aid in triage and transfer decisions and in identifying patients potentially eligible for endovascular intervention or patients who might otherwise benefit from transfer to a stroke center.”

Congress has also taken notice. The recent two-year budget deal signed by President Trump this month includes elements of The Furthering Access to Stroke Telemedicine (FAST) Act, which opens the door to Medicare coverage of telestroke services regardless of the patient’s location.

“Allowing more qualified originating sites, such as the patient’s home, ambulances, and mobile stroke units, will provide broader options for healthcare systems that do not have constant access to a neurologist and allow institutions with established stroke programs opportunities for destination medicine and new patients,” Nathaniel Lacktman, a telemedicine and telehealth expert with the Foley & Lardner law firm, and Thomas Ferrante, a senior counsel with the firm, wrote in a recent analysis of the new funding bill in the National Law Review.

Viz.AI’s Contact app is seen as a clinical decision support tool, helping doctors to more quickly identify a stroke and pull in the necessary specialist resources to begin treatment. FDA officials say the app can be used by neurovascular specialists, such as vascular neurologists, neuro-interventional specialists, or other professionals with similar training.

"The application is limited to analysis of imaging data and should not be used as a replacement of a full patient evaluation or solely relied upon to make or confirm a diagnosis," the FDA said in its notice of “de novo” premarket pathway approval.

The approval follows FDA review of a study of 300 CT images by two trained neuroradiologists and the Contact app.

"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 FDA concluded.

Source: Eric Wicklund, mHealth Intelligence