Given Imaging submits PillCam Colon 2 for FDA clearance
Given Imaging ($GIVN) finally pulled the trigger on its FDA submission for the PillCam Colon 2 endoscopy capsule. The Israeli company will seek FDA clearance to market the device to visualize the lower gastrointestinal tract.
No word yet on how this might affect Given's rumored status as an acquisition target. As of a few weeks ago, a unit of Japan's Fujifilm Holdings was reportedly contemplating a $750 million purchase of the company, according to a Globes newspaper story.
Given said it will pursue the de novo clearance regulatory pathway for PillCam Colon 2, which could allow for a quicker review process. And as promised, the company said it designed the approval application to include patients who can't receive a colonoscopy because of health risks or haven't been able to submit to a complete procedure. That shouldn't be a surprise to people because Given announced its decision in August. At the time, however, investors were angry at the move because they wanted the company to pursue a broader, general screening indication, and they drove Given's stock price down over 9%. Given has more than rebounded since then, and its stock closed Nov. 27 at $18.16, down about 1%.
Regardless of acquisition speculation or Given's approval pathway, the technology is pretty cool. As the company describes, the PillCam Colon 2 capsule includes two miniature color video cameras (one on each end), a battery and LED light. Once a patient swallows the tiny device, it transmits as many as 35 frames per second for 10 hours. A recording device worn by the patient captures all the data, which is transferred to a computer that compiles the info and formats it for a physician.
- read the release