FDA Clears Pill-Shaped Camera for Home Endoscopy

Diagnosing gastrointestinal (GI) conditions isn’t always easy. That’s because you often need to take a closer look inside the body to see what’s going on. Sometimes this involves a procedure called an endoscopy. An upper endoscopy can help your healthcare provider look for bleeding, ulcers, cancer, and other signs of a GI condition or problem. 

An endoscopy upper endoscopy typically done under some sedation in a medical setting. It involves a camera attached to a thin tube that’s usually inserted down your throat. There’s preparation, travel, and recovery involved in this process. But, what if you could do this from the comfort of your own home? 

The FDA recently cleared the PillCam SB3 System for at-home use. It’s a pill-shaped camera that can be used for at-home endoscopies. This gives people a convenient option without the travel and sedation required for traditional endoscopies.

Keep reading to learn more about the PillCam SB3 System, how it works, and what to expect. 

What is the PillCam SB3 System?

Over the past two decades, a lot of work has been done to create new technology that makes endoscopies less invasive. This includes the creation of a “smart camera pill” that captures images as it moves through your small intestines. This is called a capsule endoscopy.

The PillCam SB3 System is one example of a smart camera pill. It’s cleared for use in adults and children as young as 2 years old. But not everyone should use it. People with blockages or narrowing in their GI tract, implantable electrical devices (e.g., pacemaker), and swallowing problems shouldn’t use the PillCam SB3.

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Can it be used at home?

Previously, the PillCam products were used in medical settings. But the FDA has now cleared the PillCam SB3 for at-home use after allowing it during COVID-19. This is a significant step for home diagnostic testing. That’s because it helps avoid the issues related to scheduling and setting up the system in a medical office. 

Instead of going to a medical office, the PillCam and the rest of the supplies are delivered directly to you. A healthcare provider will walk you through the process via a telehealth appointment. You’ll need to mail the PillCam system back (but not the pill) after using it. 

How does the PillCam SB3 System work?

The PillCam SB3 System has several parts that work together to capture the images inside you. In addition to the smart camera pill, you’ll receive a sensor belt, sensory array, and recording device.

First, you’ll receive instructions on how to prep. This includes foods and drinks you can have and how long you’ll need to fast.

When you’re ready to start the process, you’ll put the sensor belt around your waist. This is connected to a recording device to collect the images from the PillCam. You’ll swallow the PillCam once it’s synced to the recording device. 

The PillCam will take images throughout its journey through your body. During this time, it will send images to the recording device over the course of about 8 hours. The capsule should completely pass through your body, usually within 24 hours. Once it’s out, you can flush it down the toilet. 

What can the PillCam SB3 System be used to detect?

The PillCam SB3 System takes images of the entire small intestine. So, it can be used to detect and monitor issues affecting the small intestine that may not get picked up by other procedures. For example, it can look for signs of Crohn's Disease or sources of bleeding. 

But the PillCam can’t diagnose anything on its own. The images it provides can help your healthcare provider arrive at a potential diagnosis. 

Will it replace an endoscopy performed by a healthcare provider?

The PillCam SB3 has several advantages over a traditional endoscopy. But there are some differences. For example, healthcare providers can perform biopsies and fix certain issues during a traditional endoscopy. This isn’t an option with the PillCam SB3.

Depending on your medical history and other factors, your healthcare provider will determine which procedure is most appropriate for you. 

As described earlier, there are a few situations where the PillCam SB3 isn’t an option. This includes scenarios where the smart camera pill could get stuck or potentially interfere with implanted devices. In this case, a traditional endoscopy may be recommended.

When will the PillCam SB3 System be available?

As mentioned above, the PillCam SB3 System was originally cleared in 2013. But the system for at-home use is more recent. Prior to this announcement, it had been given emergency clearance for use during COVID-19.

Medtronic, PillCam’s manufacturer, plans to deliver the at-home systems through Amazon. But it’s not clear when that service will be available yet.

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Written by:

Timothy Aungst, PharmD

Timothy Aungst, PharmD, has worked in pharmacy practice for the past decade with different roles and responsibilities. He has served as an associate professor of pharmacy practice for almost a decade, a clinical pharmacist in outpatient cardiology management, and now in home healthcare.

Edited by:

Alyssa Billingsley, PharmD

Alyssa Billingsley, PharmD, is the director of pharmacy content for GoodRx. She has over a decade of experience as a pharmacist and has worked in clinical, academic, and administrative roles.

Reviewed by:

Christina Aungst, PharmD

Christina Aungst, PharmD, is a pharmacy editor for GoodRx. She began writing for GoodRx Health in 2019, transitioning from freelance writer to editor in 2021.

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