CapsoVision Inc. Announces FDA Enforcement Discretion for At-Home Capsule Endoscopy Administration of CapsoCam Plus during COVID-19

SARATOGA, Calif., Sept. 23, 2020 /PRNewswire/ — CapsoVision, an innovator in the gastroenterology diagnostics market, today announced that the U.S Food & Drug Administration (FDA) will apply enforcement discretion which allows at-home administration of the CapsoCam Plus® small bowel capsule endoscope during the COVID-19 pandemic for patients who are determined eligible for at-home administration.
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US: The CapsoCam Plus® video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel. CapsoCam Plus has been cleared by the U.S. Food and Drug Administration.

International: The CapsoCam Plus® video capsule system is intended for visualization of the small bowel mucosa in patients ages two and above. It may be used as a tool in the detection of abnormalities of the small bowel.

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