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AnX Robotica Receives FDA 510(k) Clearance for MotiliCap and MotiliScan GI Motility Monitoring System

  • AnX Robotica announced FDA 510(k) clearance for MotiliCap and MotiliScan, a next-generation gastrointestinal motility monitoring system that replaces the discontinued SmartPill technology.
  • The MotiliCap capsule provides comprehensive, non-invasive assessment of whole-gut transit times across the stomach, small bowel, and colon without radiation or sedation.
  • The companion MotiliScan software enables clinicians to visualize pH, pressure, and temperature changes with customizable reporting and automated summaries for improved diagnostic workflows.
  • This clearance represents a significant advancement in GI motility monitoring, offering enhanced accuracy and patient comfort for identifying motility disorders.
AnX Robotica, a leader in advanced gastrointestinal diagnostic solutions, has received FDA 510(k) clearance for MotiliCap and its companion software MotiliScan, marking a significant advancement in GI motility monitoring technology. The clearance, announced on May 27, 2025, introduces a comprehensive, non-invasive solution for assessing whole-gut transit times with enhanced accuracy and patient comfort.

Revolutionary Motility Capsule Technology

MotiliCap represents a next-generation motility capsule designed to evaluate gastrointestinal transit across the stomach, small bowel, and colon. The device serves as the most comprehensive solution available, effectively replacing the discontinued SmartPill technology while delivering detailed insights into gastric emptying, small bowel transit, and colonic motility without requiring radiation or sedation.
The capsule technology captures critical physiological data that is seamlessly exported to the MotiliScan software platform, where clinicians can visualize pH, pressure, and temperature changes throughout the digestive tract. This comprehensive approach provides physicians with a complete view of GI motility patterns.

Advanced Software Platform for Clinical Decision-Making

The MotiliScan software provides intuitive visualization and seamless data analysis capabilities, enabling physicians to identify motility disorders and expedite treatment decisions. The platform is designed with both efficiency and precision in mind, offering customizable reporting, segment-specific analysis, and automated summaries that support improved clinical workflows and better patient outcomes.
"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," said Stu Wildhorn, Vice President of Marketing and Product Management at AnX Robotica. "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."

Expanding Diagnostic Portfolio

With this FDA clearance, AnX Robotica continues its mission to revolutionize patient care with advanced GI technologies. The company builds on the success of its NaviCam platform, which includes NaviCam SB with ProScan, NaviCam Capsule/Tether, NaviCam Xpress MCCE System, NaviCam Colon, and IntraMarX technologies.
The MotiliCap and MotiliScan system addresses a critical gap in the market following the discontinuation of SmartPill technology, providing clinicians with an enhanced diagnostic tool that combines the latest technological advances with user-friendly design and comprehensive analysis capabilities.
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