FDA Clears Activ Surgical’s Imaging Module for ActivEdge Platform

The FDA has granted 510(k) clearance for Activ Surgical’s ActivSight, an imaging software module that delivers real-time visual data and imaging during surgical procedures.

The intraoperative imaging tool will be a component of the company’s ActivEdge software platform, which has not yet been cleared by the FDA.

The platform uses artificial intelligence and machine learning to produce surgical insights. The company plans to first deliver a product that can show blood flow and perfusion in real time without the use of dyes.