PillCam capsule endoscopy has been in use for more than 20 years. Medtronic won FDA clearance for the PillCam Small Bowel (SB) 3 system for remote endoscopy procedures in late 2021. The technology is delivered straight to a patient and, via a telehealth appointment, a provider guides the patient through the remote procedure.
Over the course of an eight-hour procedure, the PillCam SB3 capsule transmits approximately 50,000 images securely to the cloud. There, a GI physician can assess the images to make a diagnosis for conditions ranging from Crohn’s disease to obscure bleeding to small bowel abnormality. The patient then returns the data recorder and sensor belt to Medtronic.
Thomas said the company designed the new kit for both in-clinic and at-home ingestion. This allows patients to undergo the procedure in the best location for them. Medtronic’s new kit also eliminates the need for that data recorder and sensor belt, replacing them with a streamlined link device.
This improvement makes the procedure more convenient and comfortable for patients compared to the previous hardware. It also gives clinics the opportunity to perform more procedures without equipment availability hampering them.
Raj Thomas, president of the medtech giant’s Endoscopy operating unit, shared news of the latest clearance in a LinkedIn post. Thomas only recently took over that post after Giovanni Di Napoli departed in March.
“For over 20 years, Medtronic PillCam has led the world in capsule endoscopy, touching over 4 million patient lives,” Thomas wrote. “Now, we’re reinventing the experience for our patients with the newly FDA-cleared PillCam Genius SB capsule kit, used to visualize the small bowel.”
Medtronic Endoscopy’s chief medical officer offers more info
Austin Chiang, chief medical officer for the Medtronic Endoscopy unit, also posted on LinkedIn to share the news of FDA clearance.
“Medtronic PillCam capsule endoscopy is getting a MAJOR update!” he wrote. “Pillcam has been around for 20 years taking pictures through in hard-to-reach parts of our bowels in over 4 million patients.
Chiang said that, before, patients had to deal with the process of going to the clinic and getting outfitted with a recording contraption. Then, they had to return it the following day.
“Not only was this equipment a rate limiting factor for doctors in offering more capsule studies, but it’s clearly not the ideal patient experience,” Chiang wrote. “NOW, the PillCam Genius SB kit will record the capsule study via a slick adhesive patch, designed for both in-clinic AND at-home ingestion, which is more comfortable, save patients extra trips to the clinic and potentially reduce wait times and improve access to care.”
