AnX Robotica has received clearance from the US Food and Drug Administration (FDA) for expanded indications of its NaviCam SB system for use in adults as well as children who are aged two years and above.
The FDA has also approved the NaviCam Tether, an accessory designed to aid in visualising the esophagus before the release of the capsule into the gastrointestinal tract.
This tether is expected to enhance the advantages of SB capsule endoscopy procedures in adults aged 22 years and above.
AnX Robotica marketing and product management vice-president 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 two years old.
“Furthermore, clinicians gain the capability to visualise the esophagus using the NaviCam Capsule/Tether before initiating a Small Bowel study.”
Prior to this development, AnX Robotica’s ProScan software received FDA approval.
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ProScan is an artificial intelligence (AI)-assisted reading tool that supports healthcare professionals in making efficient and informed decisions, enhancing patient care through the power of AI.
The NaviCam Proscan utilises a deep learning algorithm called convolutional neural networks, designed to identify and differentiate healthy tissue and abnormal lesions in different images.
Combined with the ProScan clearance, the latest milestone is expected to establish NaviCam SB as the advanced technology in small bowel video capsule endoscopy.
AnX Robotica is expanding the NaviCam platform with the introduction of the NaviCam Magnetically Controlled Capsule Endoscopy System.
The company also provides the NaviCam Colon System in Europe and IntraMarX 3D, radiopaque markers for assessing colonic transit in patients in the US.