Activ Surgical lands FDA clearance for imaging device to enhance endoscope observations

In the same vein as a universal TV remote, a newly FDA-cleared surgical module adapts to fit virtually any endoscope and camera system, instantly upgrading the intraoperative imaging data they produce.

The ActivSight device, developed by Boston-based Activ Surgical, connects to a laparoscope or arthroscope on one side and a surgical camera system on the other. Once in place, it overlays the camera feed with real-time measurements of blood flow and tissue perfusion and vascularity, allowing for better and more informed decision-making in the moment.

ActivSight is built on the company’s ActivEdge platform, which uses artificial intelligence and machine learning to generate those added insights for standard intraoperative imaging procedures.

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The device represents a significant upgrade to the usual surgical imaging techniques. Most often, a patient is injected with indocyanine green dye, which is then lit with a fluorescent light during surgery to give surgeons an indication of blood flow and tissue perfusion, though not in the form of real-time, detailed informational overlays like those offered by ActivSight.

With the FDA’s 510(k) clearance under its belt, Activ Surgical is now aiming to begin rolling out the ActivSight module in the second half of this year. So far, at least a dozen healthcare systems around the globe have signed on to become early adopters of the technology.

“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,” Peter Kim, M.D., Ph.D., co-founder and chief science and medical officer, said in a statement. "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."

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Activ Surgical first made headlines in 2016 for developing the world’s first surgical robot that could autonomously suture soft tissue. Since then, the company has raised $32 million to fund the creation of its digital surgical products, including a $15 million venture round that closed last July and was led by ARTIS Ventures.

Next on the company’s agenda is further development of its second product, ActivInsight, which will be built on the ActivEdge platform and powered by ActivSight. The software will use AI and a massive annotated imaging data set to churn out surgical analytics and guidance in real time.

Also in the pipeline are ActivAssist, which will use the ActivInsight data set to calculate the ideal positioning of endoscopes, and ActivPilot, which will perform surgeon-supervised autonomous procedures.