Mike Hollan

The device can produce AI-assisted readings.

FDA announced that it has cleared the NaviCam Small Bowel Video Capsule Endoscopy for expanded indications.

In a press release, the device’s producer AnX Robotica, revealed the agency’s decision. According to the company, the NaviCam SB is one of the most advanced pieces of technology available for small bowel video capsule endoscopy. The device uses AI to assist medical professionals as they perform tests.

FDA also cleared the company’s NaviCam Tether to be used as an accessory with the NaviCam SB. These devices are designed to work together and can improve the visualization process of the esophagus.

In a press release, AnX Robotica’s vice president of marketing and product management Stu Wildhorn said, “With FDA clearance, NaviCam Small Bowel Capsule Endoscopy represents a groundbreaking leap forward, now extending its revolutionary diagnostic capabilities to patients as young as 2 years old. Furthermore, clinicians gain the capability to visualize the esophagus using the NaviCam Capsule/Tether before initiating a Small Bowel study. This pivotal milestone underscores AnX Robotica's unwavering commitment towards advancing healthcare accessibility and precision for a broader spectrum of patients."

The NaviCam SB and Tether are part of AnX’s NaviCam platform, which includes both visual aids and therapeutic applications. According to the press release, NaviCam has plans to expand the NaviCam line.