FDA clears software that analyzes stroke images, alerts specialists using AI
The FDA announced late Tuesday, Feb. 13, that it has approved marketing of Contact, a clinical decision support software that analyzes CT results and notifies providers of potential strokes. Contact was developed by Viz.ai, a San Francisco-based healthcare company that specializes in artificial intelligence (AI) and deep learning technologies.
“Strokes can cause serious and irreversible damage to patients,” Robert Ochs, PhD, acting deputy director for radiological health, Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a prepared statement. “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.”
Contact uses an AI algorithm that searches CT images of the brain for signs of a possible stroke. If the algorithm identifies something, the algorithm immediately notifies a neurovascular specialist, potentially alerting the specialist before the first-line provider has finished its own review of the exam.
The clearance comes as the FDA is in the process of developing a “regulatory framework” for AI-related products. The agency also noted that this sets a precedent, creating a new classification that means “subsequent computer-aided triage software devices” with similar uses will also go through its 510(k) approval process.
Contact “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 noted in its statement. The product obtained a CE mark in Europe earlier this year.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.