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

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, Calif., Jan. 10, 2025 /PRNewswire/ -- 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 Medicine, Sec. Gastroenterology, 2023; World Journal of Gastroenterology, 2014). 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.

For more information about CapsoVision, please visit our website at capsovision.com.

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

SOURCE CapsoVision