AnX Robotica has announced that the FDA has granted clearance for expanded indications of its NaviCam Small Bowel Video Capsule Endoscopy (SB) in both adults and children aged 2 years and above. 

This notable achievement, combined with the recent FDA clearance of ProScan, the innovative AI-assisted reading tool for Small Bowel Video Capsule Endoscopy (VCE), solidifies NaviCam SB as the most advanced technology in small bowel vide capsule endoscopy.

Simultaneously, the FDA has also approved the NaviCam Tether as an accessory for the NaviCam SB Capsule. This purpose-built accessory aids in visualizing the esophagus before releasing the capsule into the gastrointestinal tract, enhancing the benefits of SB capsule endoscopy procedures in adults (≥ 22 years).

The recently cleared ProScan software by AnX Robotica complements clinician expertise, empowering them to make well-informed and efficient decisions for patient care with the added advantage of AI-assisted readings.

Stu Wildhorn, Vice President of Marketing and Product Management, emphasized the significance of this FDA clearance, stating, "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."

Building on these clearances and the introduction of the NaviCam Magnetically Controlled Capsule Endoscopy (MCCE) System, AnX Robotica continues to expand the NaviCam platform, introducing additional visualization aids and therapeutic applications. 

Alongside the NaviCam SB System and MCCE Systems, AnX offers the NaviCam Colon System in Europe, and in the United States, IntraMarX 3D, radiopaque markers to assess colonic transit in patients.