FDA Clears a SmartPill Alternative to the Colonoscopy


The over 50 crowd can breathe a bit easier today after FDA regulators green light a new smartpill that has been cleared as an alternative to receiving a traditional colonoscopy for some patients. Called the PillCam Colon 2, the smart pill houses two high-speed cameras, an LED that provides needed lighting, and a transmitter. Once swallowed, the smartpill captures a video recording of the GI tract as it moves through the system, and transmits the information to a hip-worn receiver for later review by a GI doctor. PillCam was approved as a direct de novo classification which is used for devices with low to moderate risk that have no equivalent on the market.

While the colonoscopy will still be the standard for most patients, those that have the misfortune of experiencing an incomplete colonoscopy now have a non-invasive alternative to returning to the GI for a repeat. In addition, patients that cannot have a colonoscopy due to allergies or other medical reasons are approved to use PillCam. Until now, there were no non-invasive, radiation-free alternatives to a colonoscopy. There are an estimated three million US patients each year that would qualify to use the PillCam.

PillCam is not new technology. Given Imaging, the Israeli-based company that developed the smartpill, received FDA approval in 2001 for a similar technology designed to inspect the small intestine. At the time, digital health enthusiasts were predicting that Given Imaging’s technology would quickly grow into a direct competitor to the traditional colonoscopy. In the US, that did not happen.

While PillCam Colon 2 has been approved for use in 80 countries globally, the FDA has held back clearance over concerns surrounding picture quality compared to the traditional colonoscopy.  In a 2009 trial, the original PillCam Colon found only 14 of 19 cancers detected by a colonoscopy.

The recently cleared PillCam Colon 2 has performed better, with a sensitivity of 88 percent and specificity of 82 percent, but still does not match the diagnostic accuracy of a colonoscopy. As a result, the pill has not been approved as a direct replacement to the traditional colonoscopy. Still, many believe that if approved as a direct replacement for a traditional colonoscopy, colorectal cancer screening rates could be significantly improved.

Even with the limited market, analysts expect that the device could hit $60 million in US sales by 2019. The pill costs only $500, compared to the $1,200 typically billed for a traditional colonoscopy.

Enjoy HIStalk Connect? Sign up for update alerts, or follow us at @HIStalkConnect.

↑ Back to top

Founding Sponsors

Platinum Sponsors