Med-Devices

AnX Robotica is Pleased to Announce FDA Clearance for Expanded Indications of NaviCam Small Bowel Video Capsule Endoscopy

AnX Robotica NaviCam Small Bowel FDA Clearance

AnX Robotica, the leader in advanced gastrointestinal visualization technologies, is thrilled to announce FDA clearance for expanded indications of its NaviCam Small Bowel Video Capsule Endoscopy (SB) in both adults and children aged 2 years and above. This significant milestone, combined with the recent FDA clearance of ProScan, the pioneering AI-assisted reading tool for Small Bowel Video Capsule Endoscopy (VCE), firmly establishes NaviCam SB as the most advanced technology in small bowel vide capsule endoscopy.

In tandem with the NaviCam SB clearance, the FDA has also approved the NaviCam Tether as an accessory for the NaviCam SB Capsule. Specifically designed to aid in visualizing the esophagus before the capsule’s release into the gastrointestinal tract, this accessory enhances the benefits of SB capsule endoscopy procedures in adults (≥ 22 years).

AnX Robotica’s ProScan software, recently cleared by the FDA, complements the expertise of clinicians to enhance their decision-making for efficient patient care. NaviCam ProScan supports empowering healthcare professionals to make well-informed and efficient decisions with the added benefit of AI-assisted readings.

“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, as remarked by Stu Wildhorn, Vice President of Marketing and Product Management, towards advancing healthcare accessibility and precision for a broader spectrum of patients.”

With these recent FDA 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. In addition to 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.

NaviCam is a registered trademark of AnX Robotica Corporation. The company remains committed to advancing gastrointestinal healthcare through innovation and cutting-edge technologies.

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