Activ Surgical announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s ActivSight Intraoperative Imaging Module for enhanced surgical visualization. The hardware agnostic imaging module has been designed to provide surgeons real-time intraoperative visual data and imaging not currently available to surgeons through existing technologies, helping to improve patient outcomes and safety in the operating room.
“Receiving FDA 510(k) clearance for our ActivSight enhanced visualization module is a significant milestone in bringing Activ Surgical’s technology to operating rooms around the world,” said Todd Usen, CEO of Activ Surgical. “Given there is a $36 billion cost for preventable surgical errors, we believe ActivSight has the potential to make an immediate impact in the OR. We look forward to working closely with our initial pilot customers over the next several months to further validate ActivSight and revolutionize surgical care.”
ActivSight is the company’s proprietary hardware imaging module that will power its next product, ActivInsights. ActivInsights will be part of the ActivEdge software platform, which will use artificial intelligence (AI) and machine learning (ML) technology to produce surgical insights. The first ActivInsight that will be made available is perfusion insights and will offer the ability to see blood flow and perfusion in real time, without the use of traditional dyes.
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