WASHINGTON — A kinder, gentler approach to one of the most dreaded exams in medicine is on the way: U.S. regulators have cleared a bite-size camera to help screen patients who have trouble with colonoscopies.
The ingestible pill camera from Given Imaging is designed to help doctors spot polyps and other early signs of colon cancer. The Food and Drug Administration cleared the device for patients who have had trouble with the cringe-inducing colonoscopy procedure, which involves probing the large intestine with a tiny camera embedded in a four-foot long, flexible tube.
The Israeli company's technology, developed from missile defense systems, uses a battery-powered camera to take high-speed photos as it slowly winds its way through the intestinal tract over eight hours. The images are transmitted to a recording device worn around the patient's waist and later reviewed by a doctor.
While Given's wireless, image-beaming system may sound like science fiction, it's actually more than a decade old. In 2001, the company received FDA approval for a similar device used to get a close-up view of the small intestine.
At that time, analysts expected Given's approach to grow into a direct competitor to traditional colonoscopy. But company studies found that images taken by the mini-camera were not quite as clear as those from the in-office procedure. As a result, the company has pursued a more limited market for its device: patients who have trouble undergoing standard colonoscopies.
The FDA on Monday cleared the company's PillCam Colon for patients who have experienced an incomplete colonoscopy. Given estimates 750,000 U.S. patients are not able to complete the procedure each year, due to anatomy issues, previous surgery or various colon diseases.
Even with this limited indication, analysts estimate the new pillcam could grow to sales of over $60 million in North America by 2019.