CapsoVision, a US-based endoscopic capsule technology developer, has received clearance from the US Food and Drug Administration (FDA) for the remote ingestion of CapsoCam Plus.
This capsule endoscopy system allows patients to ingest the CapsoCam Plus capsule at home, under virtual medical supervision.
CapsoVision said that the clearance will improve patient comfort and accessibility in diagnostic procedures for small bowel visualisation.
The latest FDA clearance follows recent approval for CapsoCam Plus use in paediatric patients aged two and older.
According to CapsoVision, CapsoCam Plus eliminates the need for hospital or clinic visits, unlike competing systems that require two trips, one for ingestion and another to return the equipment.
With recent FDA clearance for remote ingestion, eligible patients can now take the capsule at home, without requiring data recording equipment.
Its wire-free onboard storage design simplifies capsule administration and streamlines workflow for physicians and their practices. This convenience makes CapsoCam Plus suitable for expanding telehealth care, reducing patient and healthcare provider burden.
Remote ingestion of the CapsoCam Plus capsule has been successfully practised in medical centres serving remote regions of Canada, with positive outcomes reported in the Journal of the Canadian Association of Gastroenterology (2021).
In 2020, CapsoVision received FDA enforcement discretion for at-home administration during the Covid-19 pandemic, enabling eligible US patients to administer the capsule remotely.
The labelling addendum allowed fully remote capsule endoscopy for eligible patients, eliminating in-person interactions between clinic staff and patients.
The new FDA nod extends this flexibility, enabling patients to continue ingesting the CapsoCam Plus capsule without in-person clinic visits.
CapsoVision president and CEO Johnny Wang said: “We are honoured to announce the FDA’s clearance to continue remote ingestion of CapsoCam Plus.
“By offering a remote option, healthcare providers can significantly enhance patient convenience and broaden the scope of accessible care.”
The capsule endoscopy system offers high-resolution, panoramic visualisation of the small bowel mucosa, giving physicians a powerful tool to detect abnormalities.
It is said to be the only capsule endoscopy system with four cameras, providing a 360° panoramic view to enhance visibility and diagnostic accuracy.
Unlike traditional systems with a single forward-facing camera, CapsoCam’s advanced imaging minimises the risk of missed lesions by capturing detailed images of the entire small bowel. This improves diagnostic confidence and enables thorough examination of critical areas.
