FDA gives OK for home use of CapsoVision's endoscopic camera pill

FDA
Typically swallowed in front of healthcare professionals, the FDA said it would exercise its enforcement discretion to allow the unsupervised administration of CapsoVision's capsule-based endoscope, which is distributed by Pentax in Canada and the U.S. (FDA)

CapsoVision—maker of an ingestible camera pill for scanning the inside of a person’s gastrointestinal tract—has received word from the FDA that they may offer their device for fully remote, at-home use during the COVID-19 pandemic.

Since the spread of the novel coronavirus, the agency has sought various ways to lessen the amount of physical contact between patients and healthcare providers by promoting the use of digital technologies and connected devices.

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

RELATED: FDA looks to expand remote monitoring to free up hospital space

The CapsoCam Plus (CapsoVision)

Typically swallowed in front of healthcare professionals, the FDA said it would exercise its enforcement discretion to allow the unsupervised administration of the capsule-based endoscope, which is distributed by Pentax in Canada and the U.S.

The self-contained CapsoCam Plus records 360-degree images of the mucosal lining of the small intestine using four panoramic cameras. It’s designed to spot abnormalities such as ulcers or active bleeding as well as the signs of celiac disease.

The user does not need to wear any external equipment, such as a sensor belt or receiver, and the device with images on board is simply returned to the clinic after a matter of hours. The findings are then reviewed by physicians through the company’s cloud-based system.

 

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