Medtronic secures FDA clearance for PillCam SB3 @HOME procedure
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Medtronic secures FDA clearance for PillCam SB3 @HOME procedure

16 Nov 2021 (Last Updated November 16th, 2021 09:27)

The PillCam SB3 @HOME programme offers a telehealth option for monitoring and direct visualisation of the small bowel.

Medtronic secures FDA clearance for PillCam SB3 @HOME procedure
The PillCam Small Bowel 3 system is only approved for remote use in the US. Credit: Bobak Ha’Eri / commons.wikimedia.org.

Medtronic has received 510(k) clearance from the US Food and Drug Administration (FDA) for its PillCam Small Bowel 3 (SB3) @HOME endoscopy procedure.

PillCam SB3 @HOME leverages the Medtronic PillCam technology and Amazon logistics to enable remote endoscopy procedures. The FDA approval will enable patients to undergo gastrointestinal procedures under remote supervision at their homes.

The system offers a telehealth option for direct visualisation and monitoring of the small intestine. It aims to detect lesions indicating Crohn’s disease, locate obscure bleeding or identify sources of iron deficiency anaemia (IDA).

It is particularly designed to identify lesions missed during upper and lower endoscopy.

The PillCam SB3 system provides images of the mucosa. It is also equipped with adaptive frame rate technology for image acquisition and other tools required for recording those images.

This will allow the healthcare providers to interpret study results.

Medtronic medical surgical portfolio’s gastrointestinal business president Giovanni Di Napoli said: “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.

“The pandemic necessitated more remote innovation, and our capabilities have exceeded expectations to provide better quality care to patients without the risk of Covid infection and without adding to the burden on the medical staff.

“PillCam SB3 @HOME offers a convenient option for a contactless procedure and helps ensure that patients can access care in a timely manner.”

The company noted that the new system is only approved for remote use in the US.

The PillCam SB3 @HOME procedure kit can be directly delivered to patients, following a GI physician identifying an individual for a procedure.

Subsequently, a healthcare provider will remotely guide the patient on the particular date of the procedure.

Once the procedure is complete, the patient will return the data recorder, as well as the sensor belt, to Medtronic.

The PillCam SB3 capsule transmits nearly 50,000 images during the eight-hour procedure. These images are stored in the Cloud to help GI physicians with diagnosis.