Don't Put Your Health in the Hands of Artificial Intelligence Just Yet

Meanwhile, the FDA has fast-tracked approval of AI-driven products, from approving just 1 in 2014 to 23 in 2018. Many of these products haven't been subjected to clinical trials since they utilize the FDA's 510(k) approval path, which allows companies to market products without clinical trials as long as they are "at least as safe and effective, that is, substantially equivalent, to a legally marketed device." This process has made many in the AI health industry happy. This includes Elad Walach the co-founder and chief executive officer of Aidoc, a startup focused on eliminating bottlenecks in medical image diagnosis. "The FDA 510(k) process has been very effective," Walach told Healthline.