Medtronic Camera-in-a-Capsule Cleared for Home Endoscopy

(Updated)

The FDA has granted 510(k) clearance for Medtronic’s PillCam Genius SB capsule endoscopy kit which allows the patient to swallow the pill-sized camera equipment and proceed through an endoscopy at home.

The kit eliminates the need for a data recorder and sensor belt, replacing them with a streamlined link device. This enhancement makes the procedure more convenient and comfortable for patients, compared to the previous hardware, and allows clinics to perform more procedures without being limited by equipment availability.

The unit can also be deployed during a clinic visit, but the company said that remote use is safe and reliable and can be the most appropriate choice for some patients.

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