Plano, Texas, USA, October 11, 2026
AnX Robotica has highlighted documented clinical performance results for NaviCam® ProScan™, its artificial intelligence (AI)-assisted capsule endoscopy reading technology, following a recent U.S. Food and Drug Administration (FDA) clearance for another AI-assisted capsule endoscopy platform. The company’s announcement focuses on evidence submitted to the FDA demonstrating how AI-assisted image review can reduce the time required to interpret small-bowel capsule endoscopy examinations. According to the FDA’s De Novo review documentation, the prospective multicenter ARTIC study evaluated ProScan in 133 patients and found that mean small-bowel reading time decreased by 88.6%, from 33 minutes and 42 seconds with conventional reading to 3 minutes and 50 seconds with AI assistance. The findings highlight the potential of AI to support more efficient gastrointestinal diagnostic workflows while allowing clinicians to retain responsibility for interpreting examination results. The FDA also identified NaviCam ProScan as the primary predicate device in a subsequent 510(k) clearance for another AI-assisted capsule endoscopy system. The announcement emphasizes documented workflow performance rather than claiming that AI can replace clinical judgment.
ProScan AI Reduces Small-Bowel Capsule Review Time
NaviCam ProScan is designed to assist healthcare professionals reviewing images generated during small-bowel video capsule endoscopy, a diagnostic procedure in which a patient swallows a small camera-equipped capsule that captures images of the digestive tract. The technology uses AI-assisted image analysis to identify suspected abnormal images and provide information about the capsule’s location within the digestive tract. These capabilities are intended to help clinicians navigate large volumes of images more efficiently when investigating suspected small-bowel bleeding. In the ARTIC study, conventional reading required an average of 33 minutes and 42 seconds, compared with just 3 minutes and 50 seconds when ProScan-assisted reading was used. This represented an 88.6% reduction in mean reading time, with the difference reported as statistically significant (p<0.001). The study also reported a diagnostic yield of 73.7% with AI-assisted physician reading, compared with 62.4% with standard reading. Diagnostic yield refers to the proportion of examinations in which relevant findings are identified. These results suggest that AI-assisted review may improve workflow efficiency while supporting the identification of clinically relevant findings. However, ProScan is intended to assist clinicians, not function as a standalone diagnostic device, and physicians remain responsible for interpreting results and making clinical decisions.
FDA Documents Highlight AI Workflow Performance
AnX Robotica’s announcement also discusses a recently cleared AI-assisted capsule endoscopy platform whose FDA submission reported a separate reduction in mean reading time. The comparator’s 510(k) documentation reported that average review time decreased from 45.7 minutes with conventional reading to 34.4 minutes with AI assistance, representing a 24.7% reduction. The filing also reported patient-level sensitivity of 92.3% and diagnostic yield of 87.6% for the AI-assisted workflow in its reader study. The FDA identified NaviCam ProScan, which received De Novo authorization in December 2023, as the primary predicate device in the comparator’s September 25, 2026, 510(k) clearance. Although these results provide context for the development of AI-assisted gastrointestinal imaging technologies, the two systems were assessed in separate studies involving different patient populations, study designs, readers and validation datasets. Therefore, the reported percentages should not be interpreted as the results of a direct head-to-head clinical comparison. Each study provides evidence specific to the device and evaluation conditions described in its regulatory submission. This distinction is important when evaluating medical AI technologies because differences in methodology can influence reported performance and workflow outcomes.
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AnX Robotica Advances AI-Assisted Gastrointestinal Diagnostics
AnX Robotica develops capsule endoscopy technologies designed to support gastrointestinal visualization and clinical interpretation. Its NaviCam platform combines capsule-based imaging with software tools intended to assist healthcare professionals in reviewing diagnostic examinations. The company’s latest announcement highlights the importance of transparent, documented evidence when evaluating AI performance in medical technology. As healthcare organizations consider adopting AI-assisted diagnostic workflows, factors such as review time, diagnostic yield, intended use, validation methods and clinician oversight remain essential to assessing the technology’s practical value. Faster image review may help reduce the time clinicians spend evaluating lengthy capsule endoscopy recordings, potentially supporting workflow efficiency in settings where specialist resources are limited. Nevertheless, reduced reading time alone does not establish improved patient outcomes, and performance in a particular study may not automatically generalize to every clinical environment. Further clinical experience and appropriate validation will remain important for understanding how AI-assisted tools perform across different patient populations and healthcare settings. NaviCam ProScan represents an established FDA-authorized AI-assisted reading technology for small-bowel capsule endoscopy, with documented evidence supporting its intended workflow role. The announcement reinforces the growing role of AI in medical imaging while emphasizing that clinical expertise remains central to diagnosis and patient care.
Source: AnX Robotica press release
