Release Details

CapsoVision’s CapsoCam Plus® Capsule Endoscopy System Receives FDA Clearance for Pediatric Use, Offering a Comfortable, Child-Friendly Solution for Young Patients

January 9, 2025

The only capsule endoscopy system with comprehensive 360° panoramic imaging and no wearable equipment, now available for pediatric patients, ensuring a gentler, stress-free alternative to traditional capsule endoscopy procedures.

Saratoga, CA – January 9, 2025 – CapsoVision, a leader in capsule endoscopy, has announced that its  flagship product, CapsoCam Plus®, has received FDA clearance for use in pediatric patients aged  two and above. This milestone enables children to benefit from the ease and accuracy of  capsule endoscopy via a non-invasive, comfortable diagnostic option that reduces the stress  associated with traditional capsule endoscopy procedures. 

“At CapsoVision, we have a long history of prioritizing innovative diagnostics and patient  comfort,” said Johnny Wang, President and CEO of CapsoVision. “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.” 

For decades, families and physicians have faced the challenges of capsule endoscopy systems  with antiquated technology. With only one forward-facing camera, these capsule endoscopes  offer a limited “tunnel” view of the small bowel which could result in missed lesions.  Compounding this, children undergoing these procedures have traditionally been required to  endure uncomfortable equipment during the exam process. 

As a solution, CapsoCam Plus serves as the only capsule endoscopy system with four cameras  that capture a 360° panoramic lateral view of the small bowel and any abnormalities in high  resolution. This allows physicians to look directly at the mucosa where the abnormalities are  present rather than “down the tunnel,” improving visibility of potential lesions. 

In addition to higher lesion detection, CapsoCam Plus eliminates the need for the child to wear  any equipment, such as recorders, sensor belts, vests, and other devices that are attached to  the patient’s body with adhesive strips. Families no longer need to navigate the complications of  broken or disconnected devices and schedule time away from their daily responsibilities to  return the equipment after the procedure, both of which are common disadvantages of  traditional capsule endoscopy systems. Instead, CapsoCam Plus provides unmatched  convenience for pediatric patients, allowing children to ingest the capsule without being fitted  with equipment, reducing the anxiety of the procedure. After the ingestion, pediatric patients  can return to normal daily activities while the medical practice continues to focus on delivering  a quality experience for their other patients.

“The elimination of cumbersome equipment not only increases comfort, privacy, and mobility  for pediatric patients, but also reduces anxiety and fear, letting children feel less like patients  and more like themselves, free to play and enjoy their day,” said Doug Atkinson, Senior Vice  President at CapsoVision. 

The user-friendly design of the FDA-cleared retrieval system simplifies the process of verifying  capsule passage and makes capsule collection easier and less prone to errors. In doing so,  CapsoCam Plus provides peace of mind, enabling easy confirmation that the capsule has been  eliminated, thereby avoiding additional testing, such as X-rays, to verify passage.  

Healthcare providers can also leverage CapsoCloud®, CapsoVision’s advanced cloud-based  software, to easily view the diagnostic results online, improving efficiency and reducing  procedure time for gastroenterologists, nurses, and other staff. 

“CapsoCam Plus is more than just a medical advancement; it’s about empowering families to  take control of their child’s healthcare journey while ensuring that healthcare providers can  deliver high-quality care more efficiently,” added Atkinson. 

CapsoVision is dedicated to ensuring the safety and effectiveness of its products. Research  indicates that capsule endoscopy is a safe alternative to traditional diagnostic methods,  especially for pediatric patients. Studies show that this minimally invasive approach reduces  complications and discomfort associated with conventional endoscopy (Frontiers in  Gastroenterology, 2023; Journal of Gastroenterology, 2023). As CapsoVision expands its  offerings to include pediatric patients, the company remains committed to rigorous safety  standards and continuous monitoring to ensure the best outcomes for young patients. CapsoCam Plus is now available for use with pediatric patients, and families are encouraged to  speak with their pediatricians about how capsule endoscopy can provide a comfortable,  effective diagnostic experience for their children. 

 

References:

Chen, Y., Wu, G., Qu, C., Ye, Z., Kang, Y., & Tian, X. (2023). A multifaceted comparative analysis of image and video technologies in gastrointestinal endoscope and their clinical applications. Frontiers in Medicine, 10, Article 1226748. https://doi.org/10.3389/
fmed.2023.1226748

 Romero-Vázquez, J., Argüelles-Arias, F., García-Montes, J. M., Caunedo-Álvarez, Á., Pellicer-Bautista, F. J., & Herrerías-Gutiérrez, J. M. (2014). Capsule endoscopy in patients refusing conventional endoscopy. World Journal of Gastroenterology, 20(23), 7424–7433. https://doi.org/10.3748/wjg.v20.i23.7424