Abstract
Medical technology in gastroenterology spans devices, point-of-care diagnostics, digital health, and artificial intelligence. We conducted a narrative review of US Food and Drug Administration (FDA)-reviewed medical technology on the available evidence base to support uptake in clinical practice. Seven hundred thirteen new gastrointestinal devices were FDA approved or cleared between 2013 and 2023. The most frequent technologies had indications for use in general endoscopy (442 or 62.0% of all new technologies) with advanced endoscopy technologies being the second most common (172 or 24.1%). Ninety-nine new technologies had indications for use outside of the endoscopy suite. Ninety-nine percent of new technologies were FDA cleared against existing technologies through the 510(k) pathway rather than approved on new clinical data. Among the 19 devices with clinical trial data, trials were limited in sample size and generally evaluated disease-related changes or technical success rather than patient-reported outcomes that anchor drug trials. Twelve devices (63.2%) had favorable, published cost-effective data. To promote evidence-based discussion and uptake of new technology, and especially disruptive or high-risk technology, we propose a practical framework informed by balancing probable efficacy and safety and considering cost-effectiveness.