 |
|
Given Imaging's PillCam --Courtesy of Given Imaging |
After an extended waiting period, Given Imaging ($GIVN) won FDA clearance for its PillCam COLON today.
The clearance is good news for the Israeli company, but even better news for Covidien ($COV): The company struck an $860 million deal to buy Given Imaging in December--a move to gain access to Given's lucrative technology.
The device's approval marks another big win for the Israeli company, which has already attracted international attention for its groundbreaking technology. In July 2013, Japan regulatory authorities signed off on the device, creating an avenue for growth in the rapidly developing market.
PillCam COLON represents an innovation in the GI market: It received the FDA's direct de novo classification, which marks technology with no market predecessors and low to moderate risk. The device is a small capsule--12 mm x 33 mm--with a tiny color video camera on each end, and a battery and LED light source for power. Patients swallow the capsule, and it transmits four to 35 frames per second over a 10-hour period. The device will be used to detect colon polyps in patients who received incomplete colonoscopies, or if traditional evaluation methods have failed. It also offers a more cost-effective diagnostic method: only $500 per capsule, compared to $800 to $1200 for a typical colonoscopy.
"The clearance of PillCam COLON by the FDA represents a pivotal moment in the evolution of Given Imaging as a GI medical device leader," Homi Shamir, president and CEO of Given Imaging, said in a statement. "While we believe that PillCam COLON will ultimately play an important role in both the global colorectal cancer diagnostic and screening market, this initial indication is an important first step. To this end, we are making good progress in advancing additional clinical studies that should support the expanded indications."
Covidien remains optimistic about PillCam's future--and is looking forward to reaping the benefits of its success.
"We believe GI is one of the most attractive specialty procedure areas. Acquiring Given will enable Covidien to significantly expand its presence in a $3 billion GI market," said Bryan Hanson, group president of Covidien's medical devices and U.S. divisions, in a 2013 statement.
- read the release
Editor's note: This story has been updated to reflect that PillCam COLON received FDA clearance.