AnX Robotica announced today that it received FDA 510(k) clearance for its MotiliCap technology with MotiliScan companion software.
The company said in a news release that the latest clearance marks a significant step forward in gastrointestinal (GI) motility monitoring. It offers clinicians an advanced, non-invasive tool for assessing whole-gut transit times with unmatched accuracy and patient comfort.
Related: Route 92 Medical wins FDA nod for reperfusion system, reports positive study findings
MotiliCap, a next-generation motility capsule, aims to evaluate GI transit across the stomach, small bowel and colon. It replaces the discontinued SmartPill technology to deliver detailed insights into gastric emptying, small bowel transit and colonic motility. All this works without the need for radiation or sedation.
The platform seamlessly exports data to the MotiliScan software. There, clinicians can visualize pH, pressure and temperature changes. MotiliScan provides intuitive visualization and seamless data analysis to enable physicians to identify motility disorders and expedite treatment decisions.
AnX Robotica said the clearance continues its mission to “revolutionize patient care with advanced GI technologies.” It builds upon its NaviCam platform of technologies as well, the company says.
“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, VP 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.”