Biosense Modifies Urinalysis App To Comply With FDA
This article was originally published in The Gray Sheet
Executive Summary
The app developer unveiled its plans to comply with FDA regulations for its uChek urinalysis app, including the submission of a 510(k) for the full-feature product and launch of a Lite version. FDA sent a letter to Biosense questioning its earlier launch of the app without a 510(k) after an article ran in “The Gray Sheet” assessing its regulatory status.