The US Food and Drug Administration has permitted marketing of 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 the US, Viz.AI is headquartered in San Francisco.
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. 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 Viz.AI Contact application is intended to 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.
US Food and Drug Administration. FDA permits marketing of clinical decision support software for alerting providers of a potential stroke in patients. FDA Web site. February 13, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596575.htm. Accessed February 15, 2018.
This Week's Must Reads
Must Reads in FDA Actions
FDA Approves Inbrija for PD OFF Episodes, Acorda Therapeutics news release; 2018 Dec 21
FDA Approves Firdapse for Rare Autoimmune Disorder, FDA news release; 2018 Nov 28
FDA Approves Ajovy for Migraine in Adults, Teva Pharmaceutical news release; 2018 Sep 14
FDA Approves Tiglutik for Treatment of ALS, ITF Pharma news release; 2018 Sep 6
FDA Approves Diacomit for Treatment of Seizures, Biocodex news release; 2018 Aug 23