#USA #Plano #AnX Robotica #NaviCam ProScan #AI-assisted endoscopy

AnX Robotica Highlights Performance of NaviCam ProScan™

In a significant stride for medical technology, AnX Robotica has showcased the impressive performance metrics of its NaviCam® ProScan™ system, an AI-assisted capsule endoscopy reading tool. This announcement follows a recent decision by the U.S. Food and Drug Administration (FDA) regarding the clearance of another AI-assisted endoscopy platform, which provided context for the advancements made by ProScan.

The FDA’s review highlighted ProScan as a primary predicate device during the 510(k) clearance on September 25, 2026, denoted by the identifier K254230. Both ProScan and a newly cleared comparative technology are designed to assist healthcare providers in reviewing small-bowel capsule endoscopy studies, a critical process in gastrointestinal diagnostics.

Impressive Review Time Reductions

The results from the FDA submissions underscored the drastic reductions in review times facilitated by the AI technologies. ProScan demonstrated an 88.6% decrease in the median review time, which fell to an astonishing 3 minutes and 50 seconds with AI assistance from a conventional reading time of over 33 minutes. In contrast, the recently cleared AI-supported system reported a 24.7% reduction, with a median review time coming down to 34.4 minutes from 45.7 minutes. These findings were derived from independent studies and do not indicate a head-to-head performance comparison.

Comparative Study Insights

According to the FDA’s De Novo summary, the ARTIC multicenter study involving 133 patients concluded that the mean reading time with standard methods stood at 33 minutes and 42 seconds, while AI assistance brought this down dramatically. Notably, the diagnostic yield saw an impressive increase from 62.4% with traditional methods to 73.7% when employing ProScan’s AI capabilities. Similarly, for the comparator’s FDA filing, out of 111 patients studied, the AI-assisted reading achieved patient-level sensitivity of 92.3% and a diagnostic yield of 87.6%.

Tim Thomas, the Vice President of Regulatory and Clinical Affairs at AnX Robotica, emphasized the pivotal role of ProScan in reducing review times while supporting a physician-led workflow. He noted, "As AI adoption grows, it's crucial for clinicians to evaluate performance claims within the context of each system’s indications and design studies. We firmly believe that the clinical evidence backing ProScan lays a robust foundation for enhancing the efficiency of capsule endoscopy reviews."

Contextual Understanding of the Studies

It's important to understand that the studies surrounding ProScan and its comparator were separate evaluations involving distinct capsule systems, varying patient demographics, and different study methodologies. The data presented in the FDA submissions reflects each product’s unique contexts and indicates their complementary roles in supporting clinician interpreters rather than replacing them. The FDA documentation explicitly states that the responsibility of assessment lies with the clinician, and none of these AI systems are designed to serve as standalone diagnostic devices.

AnX Robotica continues to focus on the development of capsule endoscopy technology aimed at enhancing the quality and efficiency of gastrointestinal imaging and interpretation. The advancements brought forth by ProScan signify the shifting paradigm towards integrating artificial intelligence into medical diagnostics, offering substantial benefits to both healthcare providers and patients.