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# CapsoVision Capsule Endoscopy Home Use Cleared
- URL: https://www.fdaweb.com/capsovision-capsule-endoscopy-home-use-cleared/
- Published: 2025-01-10T12:00:00.000Z
- Updated: 2026-09-14T14:50:39.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158469

FDA has cleared a CapsoVision 510(k) for its CapsoCam Plus capsule endoscopy system for remote ingestion. The action clears the path for 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,” the company says.

CapsoVision says the CapsoCam Plus 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. The company’s remote ingestion clearance allows patients to 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,” it says.

The company says the clearance extends the flexibility that was awarded to the company during the Covid-19 emergency that allowed the devices to be used at home. “The new FDA clearance allows patients to continue to ingest the CapsoCam Plus capsule beyond the initial flexibility granted during the pandemic,” it says. The device is designed for high-resolution, panoramic visualization of the small bowel mucosa for detecting abnormalities.