CapsoVision announced that it received FDA enforcement discretion to allow at-home administration of its CapsoCam Plus.
Saratoga, Calif.-based CapsoVision’s CapsoCam Plus is a small bowel capsule endoscope intended for the visualization of the small bowel mucosa in adults. It does not require external equipment to be worn by the patient and it can be returned to the clinic in 8-12 hours and disinfected between use.
Patients ingest the capsule and return to normal activities while images are captured and then reviewed by a physician via the CapsoCloud software, according to a news release.
The FDA’s enforcement discretion permits a fully remote capsule endoscopy procedure for eligible patients, eliminating the need for in-person interaction to promote safety during the COVID-19 pandemic.
“CapsoVision’s advanced capsule technology delivers high-quality diagnostic images without creating a risk of in-person exposure to COVID-19,” CapsoVision president & chief technology officer Johnny Wang said in the release. “Our team is proud to contribute during the pandemic and to continue to innovate within the emerging telehealth paradigm.”