WASHINGTON — Given Imaging Ltd. has won US approval for an ingestible pill camera that can help doctors screen the large intestine for early signs of colon cancer.
The Israeli company’s technology uses a battery-powered camera to take high-speed photos of the intestinal tract over eight hours. The images are transmitted to a recording device on the patient’s waist.
Analysts originally expected Given’s approach to compete with traditional colonoscopy procedures. But company studies found that images from the mini-camera are not clear as those from in-office procedures. So the company has pursued a more limited market for its PillCam Colon: patients who have trouble undergoing standard colonoscopies. The Food and Drug Administration approved it for patients who have experienced an incomplete colonoscopy. The company estimates 750,000 US patients are not able to complete the procedure each year, due to anatomy issues, previous surgery, or various colon diseases.
Analysts estimate the pillcam could have sales of more than $60 million in North America by 2019, with room for expansion as the technology improves.
In December, the Irish medical device firm Covidien said it would buy Given for $860 million.
Pillcam Colon was previously approved in 80 other countries, including in Japan, Europe, and Latin America.