Plano-based AnX Robotica has received FDA 510(k) clearance for its MotiliCap device and companion MotiliScan software, marking what the company calls a major step forward in gastrointestinal motility monitoring. The system offers clinicians a non-invasive tool for assessing whole-gut transit, aiming to improve diagnostic accuracy and patient comfort.

A look at AnX Robotica’s MotiliCap capsule, as shown in the company’s LinkedIn announcement video following FDA clearance. (Image not to scale.)

MotiliCap is a next-generation motility capsule designed to evaluate GI transit across the stomach, small bowel, and colon without the need for radiation or sedation. According to AnX Robotica, the system is intended to serve as the most comprehensive solution currently available, following the discontinuation of the SmartPill technology.

That gap emerged in 2023, when Medtronic discontinued SmartPill—a wireless ingestible capsule about the size of a large vitamin capsule that had provided clinicians with a tool to monitor pressure, pH, transit time, and temperature through the gastrointestinal tract, according to MD Edge.

At the time, Braden Kuo, MD, a motility specialist at Massachusetts General Hospital who took part in SmartPill’s development and testing, noted that while its clinical adoption was “not extremely widespread,” thousands of SmartPills were still used in GI clinics each year, particularly in major metropolitan areas where insurance coverage was more common. Kuo added that the decision to discontinue SmartPill was well-known among GI specialists and had raised concerns, as no directly analogous FDA-approved device was available on the market at the time.

Now AnX Robotica’s MotiliCap system steps into the space for next-generation, non-invasive solutions, according to Stu Wildhorn, vice president of marketing and product management at AnX Robotica. Data from the capsule is transferred to the MotiliScan software, where clinicians can visualize pH, pressure, and temperature changes, offering a detailed view of GI motility.

“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 Wildhorn in a statement. “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 roots go back to 2008, when its founders began designing the basic robotic capsule endoscopy technology in Silicon Valley. In 2009, they launched ANKON Medical Technologies, the first company to commercialize a “Magnetically Controlled Capsule Endoscope System.”

The U.S.-based AnX Robotica was established in 2019 and entered a commercial agreement to share products and technologies with ANKON.

Headquartered in Plano, Anx Robotica says it integrates technologies such as precise magnetic control, in-house ASIC design, artificial intelligence, micro-optical imaging, image processing, and wireless transmission, noting more than 200 patents granted or pending and dozens of clinical papers published in international journals.

Don’t miss what’s next. Subscribe to Dallas Innovates.

Track Dallas-Fort Worth’s business and innovation landscape with our curated news in your inbox Tuesday-Thursday.