Year-end review for colon cancer device?:
This article was originally published in Clinica
Executive Summary
SpectraScience has said it is confident that the US FDA will review its premarket approval (PMA) application for the Optical Biopsy system for colorectal cancer later this year. The Minneapolis, Minnesota-based company met with the FDA in mid-July to discuss the PMA, which proposes the device's use as an adjunct to colonoscopy to avoid biopsy tissue removal. The next scheduled meeting of the FDA's gastroenterology and urology panel is November 18-19, the company pointed out.