Sam Brusco, Associate Editor01.15.24
AnX Robotica has gained U.S. Food and Drug Administration (FDA) clearance for expanded indications of its NaviCam small bowel video capsule endoscopy (SB) for patients aged two and up.
Earlier this month, the company earned FDA clearance of ProScan, its pioneering artificial intelligence (AI)-assisted reading tool for small bowel video capsule endoscopy (VCE).
In addition to the NaviCam SB clearance, the FDA also approved the NaviCam Tether as an accessory for the NaviCam SB capsule. It’s designed to help visualize the esophagus before the capsule is released into the gastrointestinal (GI) tract, which the company said enhances the benefits of SB capsule endoscopy procedures in adults over 22 years of age.
"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,” said Stu Wildhorn, VP of marketing and product management at AnX Robotica. “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."
In addition to the NaviCam SB and MCCE systems, AnX offers the NaviCam colon system in Europe, and in the U.S. IntraMarX 3D, radiopaque markers to assess colonic transit in patients.
Earlier this month, the company earned FDA clearance of ProScan, its pioneering artificial intelligence (AI)-assisted reading tool for small bowel video capsule endoscopy (VCE).
In addition to the NaviCam SB clearance, the FDA also approved the NaviCam Tether as an accessory for the NaviCam SB capsule. It’s designed to help visualize the esophagus before the capsule is released into the gastrointestinal (GI) tract, which the company said enhances the benefits of SB capsule endoscopy procedures in adults over 22 years of age.
"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,” said Stu Wildhorn, VP of marketing and product management at AnX Robotica. “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."
In addition to the NaviCam SB and MCCE systems, AnX offers the NaviCam colon system in Europe, and in the U.S. IntraMarX 3D, radiopaque markers to assess colonic transit in patients.