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Medtronic Gets FDA’s 510(k) clearance for PillCam Endoscopy System

November 17, 2021

Medtronic has received the FDA’s 510(k) clearance for its PillCam Small Bowel 3 system for remote endoscopy procedures.

Ppreviously authorized for emergency use during the COVID-19 pandemic, the system combines Medtronic's PillCam technology with Amazon logistics so that patients can receive gastrointestinal care at home.

The home version of the system offers a telehealth option for direct visualization and monitoring of the small bowel. It can help detect lesions not detected by upper and lower endoscopy that may indicate Crohn's disease, locate obscure bleeding or identify sources of iron deficiency anemia.

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