Activ Surgical, a digital surgery pioneer, received (FDA) 510(k) clearance of the company’s ActivSight Intraoperative Imaging Module for enhanced surgical visualization. The hardware-agnostic imaging module, designed to provide surgeons with real-time intraoperative visual data and imaging to improve patient outcomes and safety in the operating room.
Todd Usen, CEO, Activ Surgical, said: “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. 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 offering the ability to see blood flow and perfusion in real-time, without the use of traditional dyes.
Dr. Peter Kim, Founder and CSMO, Activ Surgical, said: “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.”