Given Imaging (NASDAQ: GIVN) announced today it has received clearance from the U.S. Food and Drug Administration (FDA) for its PillCam COLON camera that can be used for patients who have incomplete colonoscopies.
"The clearance of PillCam COLON by the FDA represents a pivotal moment in the evolution of Given Imaging as a GI medical device leader. This important event caps a string of significant regulatory milestones for our company," noted Given Imaging President and CEO Homi Shamir. "We look forward to working closely with the U.S. gastroenterology community to bring this clinically proven, diagnostic tool to patients."
The PillCam COLON is a tool to detect colon polyps in patients after an incomplete optical colonoscopy where the complete review of the colon was not possible. It is equipped with two video cameras (it measures 12 mm x 33 mm) and records video for up to 10 hours by transmitting the video to a device worn by the patients. That video is then reviewed by a physician to evaluate the patients.
The press release noted that the company estimates the global market opportunity for PillCam COLON stands at 3 million annual procedures and it is already currently available in more than 80 markets across the globe. It estimates the U.S. market opportunity will be close to 750,000 annual procedures. This is also the fourth product that Given Imaging has had cleared in the last year.
The Israeli company's technology uses a battery-powered camera to take high-speed photos as it slowly winds its way through the intestinal tract. 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 with traditional colonoscopy. But company studies found that the 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 PillCam: patients who have trouble undergoing standard colonoscopies.
"Adding Given's portfolio of diagnostics to our portfolio accelerates Covidien's strategy of providing physicians with products that support the patient along the care continuum from diagnosis to treatment," said Covidien's Group President, Medical Devices & U.S., Bryan Hanson, of the acquisition. "It also confirms our leadership in developing less-invasive screening, diagnosis and treatment solutions that can improve patient outcomes and lower health care costs.
-- Material from The Associated Press was used in this report.