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Home » FDA clears CapsoVision capsule endoscopy tech for pediatric patients

FDA clears CapsoVision capsule endoscopy tech for pediatric patients

January 10, 2025 By Sean Whooley

CapsoVision CapsoCam Plus (1)
The CapsoCam Plus system. [Image from CapsoVision]
CapsoVision announced today that the FDA cleared its CapsoCam Plus system for use in pediatric patients aged two and above.

The CapsoCam Plus system delivers a non-invasive, comfortable endoscopy in the form of a capsule device. Saratoga, California-based CapsoVision designed its system with four cameras. It delivers a 360° panoramic lateral view of the small bowel and any abnormalities in high resolution. This enables physicians to look directly at the mucosa where abnormalities are present, rather than “down the tunnel,” improving visibility of potential lesions.

CapsoCam Plus also eliminates the need for children to wear any equipment. That includes recorders, sensor belts, vests, and other devices attached to the patient’s body with adhesive strips. Families no longer need to deal with broken or disconnected devices or returning the equipment after the procedure. CapsoVision says these are common disadvantages with traditional capsule endoscopy systems.

After ingestion, pediatric patients can return to normal daily activities. The user-friendly design of the retrieval system simplifies the process of verifying capsule passage as well, eliminating the need for additional testing or X-ray. CapsoCam also features CapsoCloud, the company’s advanced cloud-based software. This enables providers to easily view the diagnostic results online, improving efficiency and reducing procedure time.

“At CapsoVision, we have a long history of prioritizing innovative diagnostics and patient comfort,” said Johnny Wang, president and CEO. “With the clearance of CapsoCam Plus for pediatric use for patients aged two and above, we can now extend these offerings to our most vulnerable population, ensuring they receive the care and attention they need. CapsoCam is a child-friendly solution that significantly improves patient, parent, and provider experience while enhancing clinical accuracy and diagnostic confidence.”

Filed Under: Diagnostics, Endoscopic, Food & Drug Administration (FDA), Health Technology, Imaging, Pediatrics, Regulatory/Compliance, Software / IT Tagged With: CapsoVision, FDA

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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