Publication/Creation Date

September 23 2020

Creators/Contributors

CapsoVision, Inc. (creator)
Food And Drug Administration (FDA) (contributor)

Description

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. The labeling addendum permits a fully remote capsule endoscopy procedure for eligible patients, eliminating the need for in-person interaction between clinic staff and patient.

Augments

Diagnosing, Sensing, Seeing

Technology Keywords

Ingestible Electronic Devices, Capsule Endoscopies, Medical Imaging, Cameras, Sensors, Remote Monitoring, Remote Patient Monitoring

Keywords

Medical, Health, COVID-19, Pandemic, Regulation

Marketing Keywords

CapsoVision, CapsoCam Plus

Source

https://www.prnewswire.com/news-releases/capsovision-inc-announces-fda-enforcement-discretion-for-at-home-capsule-endoscopy-administration-of-capsocam-plus-during-covid-19-301136268.html