FDA Approves Marketing of Clinical Decision Support Software for Stroke Triage in Midst of Renewed Focus on Digital Health Applications

The U.S. Food and Drug Administration (“FDA”) recently approved the Viz.Ai Contact application, a type of clinical decision support software designed to analyze computed tomography (CT) results that may notify providers of a potential stroke in their patients. In an article published March 8, 2018 as a PG Alert Email from the American Health Lawyers Association (“AHLA”), associate Jennifer M. Tharp discussed the recent approval of the software and its relation to the FDA’s increasing attention to digital health applications. The alert also explores the FDA’s digital health application approval process, and the agency’s intention to reduce the time and cost of market entry of digital health technologies.