FDA Allows Use of CapsoVision’s Capsule Endoscope at Home
The FDA has said it will allow CapsoVision’s CapsoCam Plus, a small bowel capsule endoscope, to be used at home during the pandemic.
The agency said it will exercise “enforcement discretion,” meaning that it won’t enforce its normal requirements for the devices because it has determined that the risk to patients is low.
Patients ingest the capsules and then return to their normal activities, as the self-contained capsules do not require any external equipment to be worn. New labeling has been added to the device that allows the remote capsule endoscopy procedure for eligible patients.