The FDA has granted 510(k) clearance for Medtronic’s PillCam Small Bowel 3 @HOME endoscopic capsule device which allows the patient to swallow the pill-sized camera equipment and proceed through an endoscopy at home.

The PillCam was first approved in 2001, Medtronic said in a press statement. Patients order the entire assembly — the camera-bearing capsule, sensor belt, data recorder and a pouch for the recorder — from Amazon. During a remote telehealth visit, a clinician walks the patient through the equipment setup.

Over the course of the eight-hour procedure, the PillCam capsule transmits approximately 50,000 images. These images are securely transferred to the cloud, then read by a gastroenterologist. After the procedure, the patient returns the hardware devices to Medtronic. The entire unit is priced at $580 on Amazon.

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