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FDA Will Allow At-Home Administration of Capsule Endoscope During COVID-19

capsule endoscope Product image courtesy of CapsoVision
FDA will apply enforcement discretion to allow at-home administration of CapsoVision's CapsoCam Plus small bowel capsule endoscope during the COVID-19 pandemic for patients who are eligible for at-home administration.

One concern that hasn't been clearly addressed during the ongoing COVID-19 pandemic is how to ensure that patients continue to receive preventative care and early-detection screening without increasing their risk of contracting SARS-CoV-2, the coronavirus that causes COVID-19. Recent news from CapsoVision suggests that FDA is beginning to address those concerns.

Saratoga, CA-based CapsoVision reported this week that FDA will apply enforcement discretion allowing 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 the patient.

"CapsoVision's advanced capsule technology delivers high-quality diagnostic images without creating a risk of in-person exposure to COVID-19," said Johnny Wang, president and chief technology officer at CapsoVision. "Our team is proud to contribute during the pandemic and to continue to innovate within the emerging telehealth paradigm." 

Along with its 360° panoramic view, CapsoCam Plus is a self-contained capsule endoscopy system that does not require external equipment for patients to wear and return to the clinic in 8-12 hours and disinfected between each use, the company noted. Patients simply ingest the capsule and return to their normal activities while the exam data is being captured. The images can then be reviewed by the physician via the CapsoCloud cloud-based software.

"The COVID-19 pandemic has challenged all physicians to rethink the way we deliver care now, and going forward," said Javier Parra, MD, a Miami, FL-based gastroenterologist with Gastro Health. "We need to do everything possible to continue to deliver healthcare in a timely and safe manner, while making an effort to reduce in-person contact and potential Coronavirus exposure. The CapsoCam Plus system will now allow us to offer this procedure to the appropriate patients efficiently and effectively, without the patient needing to visit the clinic. This is an added value to our practice and enables us to reduce exposure risks to our patients and staff while continuing the normal volume of office visits."

The CapsoCam Plus video capsule system is intended for the 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 is also distributed by Pentax Medical in the United States and Canada.

Product image courtesy of CapsoVisioncapsule endoscope

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