Avantis submits 510(k) to FDA for reposable panoramic device for colonoscopy

Avantis Medical Systems announced the submission of a 510(k) to allow its Third Eye Panoramic device to be used as a reposable product for colonoscopy, according to a press release.

The company’s Third Eye Panoramic device, initially approved by the FDA in November 2014 as a disposable product, is a novel dual-camera imaging device designed to help colonoscopists detect polyps behind folds in the wall of the colon by providing an ultra-wide-angle view of more than 300 degrees. Avantis has since redesigned the device to make it safe for multiple uses before being disposed.

“In today’s healthcare environment, it is not enough just to raise the quality of procedures and thereby improve patient outcomes. The best innovations also help healthcare providers to contain costs,” Anthony DiTonno, CEO of Avantis Medical Systems, said in the press release. “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.”

The submission has passed FDA’s administrative acceptance review and is now undergoing a substantive review, according to the press release. The FDA has 90 days to approve the device or seek additional information. The FDA is also reviewing the device’s cleaning and disinfection protocols, which are similar to those used to reprocess colonoscopes between uses.

Disclosure: DiTonno is an employee of Avanatis.