The Food and Drug Administration (FDA) has cleared the PillCam™ Small Bowel 3 @HOME program, which allows patients to undergo endoscopy procedures under remote supervision in their homes.

Using Medtronic’s PillCam technology with Amazon logistics, the system offers a telehealth option for direct visualization and monitoring of the small intestine to help detect lesions that may be missed during upper and lower endoscopy. The PillCam SB3 capsule is intended for visualization and monitoring of lesions that may indicate Crohn disease, or lesions that may be a source of obscure bleeding or that may be a cause of iron deficiency anemia.

The PillCam SB3 @HOME kit is delivered to the patient once a procedure date has been confirmed. The health care provider guides the patient through the remote procedure through a telehealth appointment. The PillCam SB3 device consists of a small capsule that is designed to be swallowed and is equipped with a camera that captures images at a frame rate of 2 to 6 frames per second (based on capsule speed as it travels through the small bowel).

Once completed, the patient returns the data recorder and sensor belt (both worn during the procedure) to Medtronic. Approximately 50,000 images are captured over the course of the 8 hour procedure; these images are securely transferred to the cloud for review by the clinician. Using advanced algorithms, the software helps providers interpret the study results.


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“As the future of medicine continues to move toward remote settings, we have great opportunity to deliver diagnostic testing and other minimally invasive procedures from patients’ homes,” said Giovanni Di Napoli, president of the Gastrointestinal business, which is part of the Medical Surgical Portfolio at Medtronic. “PillCam SB3 @HOME offers a convenient option for a contactless procedure and helps ensure that patients can access care in a timely manner.”

Reference

Medtronic announces 510(k) clearance for PillCam™ Small Bowel 3 @HOME endoscopy procedure. News release. Medtronic plc. Accessed November 16, 2021. https://www.prnewswire.com/news-releases/medtronic-announces-510k-clearance-for-pillcam-small-bowel-3-home-endoscopy-procedure-301423726.html