AnX Robotica has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its MotiliCap device and its accompanying software, MotiliScan, aimed at enhancing gastrointestinal (GI) motility monitoring.
The MotiliCap motility capsule provides a non-invasive method to assess full gut transit times across the stomach, small bowel, and colon. This product offers an alternative to the discontinued SmartPill, allowing for detailed analysis of gastric emptying and intestinal transit without requiring radiation or sedation.
The accompanying MotiliScan software enables clinicians to visualise data related to pH, pressure, and temperature, aiding in the diagnosis of motility disorders and improving treatment decisions.
The MotiliScan programme is said to present data in an easily interpretable format, facilitating segment-specific analysis and generating automated summaries to streamline clinical workflows.
AnX Robotica marketing and product management vice president Stu Wildhorn said: “We are thrilled to receive FDA clearance for MotiliCap and MotiliScan, reinforcing our commitment to bringing innovative, patient-friendly diagnostic tools to patients and our customers.
“MotiliCap not only fills the void left by SmartPill but enhances it with the latest technologies, customer friendly ease of use and analysis capabilities, empowering clinicians with faster, more accurate diagnostic insights.”
AnX Robotica’s portfolio includes the NaviCam platform, which features products such as NaviCam SB with ProScan and the NaviCam Capsule/Tether system. However, the Colon Capsule is not available in the US market.
Earlier this month, AnX Robotica introduced NaviCam XS, NaviCam XST, and ESView 3.0 at Digestive Disease Week (DDW) 2025. These innovations garnered significant attention from the medical community.
NaviCam XS is a compact capsule designed to improve patient comfort without sacrificing image quality or diagnostic effectiveness.
Both NaviCam XS and XST offer real-time oesophageal imaging via a tethered design, allowing for procedures without sedation. ESView 3.0 enhances diagnostic processes with improved image clarity and a user-friendly interface that supports faster interpretation and report generation.
