Avantis Medical Systems has begun the 510(k) process with the U.S. Food and Drug Administration for its Third Eye Panoramic device.
The device contains two video cameras designed to help physicians better find and visualize adenomas. The device can attach to the tip of any standard colonoscope.
The Third Eye Panoramic device was previously cleared by FDA as a disposable product. Now, the product has been reengineered to be a resposable instrument.
The device has passed the administrative phase of the FDA's review and will now enter the substantive review process.
"The resposable version of the Third Eye Panoramic device will provide physicians a cost-effective option to improve visualization during colonoscopies, which we believe will be an important contributing factor to broaden adoption of this important technology," said Anthony DiTonno, CEO of Avantis.