CapsoVision Reports US FDA 510(k) Submission for AI-Assisted Reading Module in CapsoCam Plus
Shots:
- The company has submitted a 510(k) application to the US FDA for its proprietary AI-assisted module designed for use with CapsoCam Plus
- The CapsoCam Plus capsule endoscopy system is designed to visualize small bowel mucosa and detect abnormalities in adults and children (age ≥ 2 yrs)
- The reading tool is expected to improve the detection of clinically significant pathology and reduce clinician review time. US commercialization is planned following FDA clearance
Ref: GlobeNewswire | Image: CapsoVision | Press Release
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