Activ Surgical™, a digital surgery pioneer, today 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.
"My mission when I founded Activ Surgical in 2017 was to democratize surgical care by extending insights from experienced surgeons to all surgical systems, ensuring world class surgical care for everyone around the world," said Dr. Peter Kim, Founder and CSMO, Activ Surgical. "The FDA clearance of our ActivSight enhanced visualization modules brings us one step closer to bringing this vision to fruition, in addition to improving patient safety and surgical outcomes for all."
To date, 13 major healthcare systems around the world have committed to ActivSight's initial launch, which is planned for the second half of 2021.