November 16, 2021 – Medtronic plc (Dublin, OH) announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its PillCam Small Bowel 3 system for remote endoscopy procedures.
The PillCam SB3 @HOME program combines Medtronic’s PillCam technology with Amazon logistics, so patients can receive timely and accurate results from the comfort of their homes.
PillCam SB3 @HOME provides a telehealth option for direct visualization and monitoring of the small bowel, to help better detect lesions not detected by upper and lower endoscopy that may: 1) indicate Crohn’s disease, 2) locate obscure bleeding, or 3) identify sources of iron deficiency anemia (IDA).
The system is designed to deliver images of the mucosa and offers innovative features, such as adaptive frame rate technology, to support image acquisition that is uniquely suited to each patient’s motility, as well as the tools needed to record those images and allow the clinician to interpret study results. The software’s advanced technology helps providers read and interpret study results, efficiently, the company says.
PillCam Small Bowel 3 is only cleared for remote use in the U.S. It is not approved for this use in other geographies.
Prior to the 510(k) clearance, PillCam SB3 @HOME was given temporary FDA-approval during the National Public Health Emergency. Medtronic’s PillCam capsule endoscopy has been used for more than 20 years as a minimally invasive, patient-friendly option for the detection of gastrointestinal diseases.