Given Imaging has announced it has filed an FDA application seeking regulatory clearance to market its PillCam COLON 2 for visualization of the lower gastrointestinal tract, according to a news release.
The PillCam COLON 2 capsule is equipped with two miniature color video cameras, a battery and an LED light source. It is designed to be ingested by the patient and transmit up to 35 frames per second for approximately 10 hours to a recording device worn by the patient.
"Filing for FDA clearance is another important milestone for Given Imaging in advancing our efforts to commercialize PillCam COLON 2," said Homi Shamir, president and CEO of Given Imaging, in the release. "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."
Given Imaging is headquartered in Israel.
Related Articles on New Technology:
Carl Zeiss Meditec Launches New Optical Coherence Tomography Products
Coloplast Launches Single Incision Sling System
Bausch + Lomb Set to Launch New Femtosecond Laser and Hydrophobic Acrylic IOL