Yoqneam, Israel-based company Given Imaging submits FDA applications, hoping for approval for its PillCam Colon 2 capsule endoscopy system via the FDA's direct de novo pathway.
Given Imaging submitted for FDA approval its PillCam Colon 2 capsules endoscopy system, a device designed for the visualization of the colon.
The Israel-based company hopes to get the FDA nod through the federal watchdog agency's de novo approval pathway.
The PillCam Colon 2 capsule endoscopy system could help patients with high risk or incomplete optical colonoscopy minimize the potential adverse events and reduce the risks of CT colonography or double-contrast barium enema procedures, according to a press release.
"Filing for FDA clearance is another important milestone for Given Imaging in advancing our efforts to commercialize PillCam Colon 2," president & CEO Homi Shamir said in prepared remarks. "We believe that PillCam Colon 2 meets a significant unmet need for a non-invasive imaging tool for visualization of the lower GI tract for physicians and their patients who are unable to undergo colonoscopy or in cases of an incomplete colonoscopy."
About 147,000 people in the U.S. are diagnosed with colorectal cancer annually, according to the National Cancer Institute, but only 50% of population undergo colonoscopy in the U.S., according to the press release.
The PillCam Colon 2 system features 2 miniature color video cameras and could be ingested by the patient, transmitting up to 35 frames per second for approximately 10 hours inside the body, the company said.
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