SARATOGA, Calif., Jan. 21, 2025 /PRNewswire/ — CapsoVision, Inc., a leader in innovative endoscopic capsule technology, today announced that its award-winning product, the CapsoCam Plus® capsule endoscopy system, has received U.S. Food & Drug Administration (FDA) clearance for remote ingestion. This milestone allows patients to conveniently ingest the CapsoCam Plus capsule from the comfort of their homes under virtual medical supervision, representing a transformative step in enhancing patient accessibility and comfort in diagnostic procedures for small bowel visualization.

CapsoCam Plus is unique in that it typically does not require a visit to a hospital or clinic – unlike competing capsule endoscopy systems, which require two visits: one for ingestion and another to return the equipment. With the recent remote ingestion clearance by the FDA, eligible patients can now avoid clinic visits entirely. They can ingest the capsule from the comfort of their own home and go about their day without any external data recording equipment. The wire-free onboard storage design makes capsule administration faster and easier, while streamlining the workflow for physicians and their practices. This convenience makes the CapsoCam Plus system an ideal tool for expanding care through telehealth and reducing the burden on both patients and healthcare providers.

The remote ingestion of the CapsoCam Plus capsule is practiced in medical centers serving patients in remote regions of Canada, with favorable outcomes reported in the literature (Journal of the Canadian Association of Gastroenterology, 2021)¹. And in 2020, CapsoVision received enforcement discretion from the FDA during the COVID-19 pandemic for patients determined eligible for at-home administration in the U.S. The labeling addendum permitted a fully remote capsule endoscopy procedure for eligible patients, eliminating the need for in-person interaction between clinic staff and patients. The new FDA clearance allows patients to continue to ingest the CapsoCam Plus capsule beyond the initial flexibility granted during the pandemic.