April 9, 2021

ActivSurgicalModule400x275Activ Surgical, which develops digital surgical technologies, has announced that the Food and Drug Administration (FDA) has given 510(k) clearance for the company’s ActivSight Intraoperative Imaging Module for enhanced surgical visualization. The hardware-agnostic imaging module is designed to give surgeons real-time intraoperative visual data and imaging not currently available to them through existing technologies. The company said this can 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.”

The ActivSight proprietary hardware imaging module will power its next product, ActivInsights. This will be a part of the ActivEdge software platform, which will use artificial intelligence and machine learning 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 of Activ Surgical. “The FDA clearance of our AcctivSight enhanced visualization modules brings us one step closer to bringing this vision to fruition, in addition to improving patient safety and surical outcomes for all.”

The company said 13 major healthcare systems around the world have committed to ActivSight’s initial launch, which is planned for the second half of 2021. For more details on the company and its technologies, visit the ActivSight website.

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