CapsoVision has received the US Food and Drug Administration (FDA) clearance for CapsoCam Plus, a capsule endoscopy device for paediatric patients.
The company’s flagship product has been approved for children aged two years and older.
Additionally, the California-based CapsoVision secured FDA approval for remote ingestion of the capsule, thereby improving patient accessibility and comfort in diagnostic procedures for small bowel visualisation.
CapsoCam Plus offers a non-invasive, comfortable, and highly accurate diagnostic alternative to traditional capsule endoscopy procedures.
According to CapsoVision, conventional systems typically rely on a single forward-facing camera, resulting in a narrow, “tunnel-like” view of the small bowel that may overlook lesions.
CapsoCam Plus features four cameras that offers a 360° panoramic view of the small bowel.
This advanced technology provides high-resolution images, allowing physicians to view mucosal abnormalities, enhancing visibility of potential lesions directly.
CapsoVision said that CapsoCam Plus improves lesion detection and eliminates the need for bulky equipment. Unlike traditional systems, it doesn’t require children to wear recorders, sensor belts, or vests that are attached to the patient’s body with adhesive strips.
It also eliminates the hassle of broken or disconnected devices and avoids returning equipment after the procedure.
The endoscopy system offers unmatched convenience, allowing children to simply ingest the capsule without being fitted with equipment so that they can return to normal activities. This reduces anxiety and enables medical practices to focus on providing quality care for all patients.
CapsoVision president and CEO Johnny Wang said: “At CapsoVision, we have a long history of prioritising innovative diagnostics and patient comfort.
“With the clearance of CapsoCam Plus for paediatric 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.”
The FDA-cleared retrieval system of CapsoCam Plus simplifies capsule passage verification, making collection easier and reducing errors. Its user-friendly design offers peace of mind by confirming the capsule has been eliminated, eliminating the need for additional tests like X-rays to verify passage.
Additionally, healthcare providers can use CapsoCloud, CapsoVision’s advanced cloud-based software, to easily view diagnostic results online. This enhances efficiency and reduces procedure time for gastroenterologists, nurses, and staff.
