The hardware-agnostic imaging module offers surgeons real-time intraoperative visual data and imaging


The FDA has approved Activ Surgical’s intraoperative imaging module. (Credit: Zahid H Javali from Pixabay)

Activ Surgical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its ActivSight intraoperative imaging module for enhanced surgical visualisation.

The company has designed the hardware-agnostic imaging module to provide surgeons real-time intraoperative visual data and imaging, which may not possible with existing technologies.

ActivSight is said to be the company’s hardware imaging module that will power its next product called ActivInsights.

ActivInsights will be part of the ActivEdge software platform, which will use artificial intelligence (AI) and machine learning (ML) technology to generate surgical insights..

To be made available as perfusion insights, the first ActivInsight is expected to help see blood flow and perfusion in real time without using traditional dyes.

Activ Surgical CEO Todd Usen 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.”

According to the company, 13 major healthcare systems across the world have pledged to ActivSight’s initial launch, which is planned for the second half of this year.

The company’s ActivEdge surgical intelligence software offers surgeons with critical and real-time guidance to achieve enhanced possible outcomes.

In July last year, Activ Surgical announced the close of a $15m venture round, which was led by ARTIS Ventures and participated by LRVHealth.

The funding round was also participated by existing investors DNS Capital, GreatPoint Ventures (GPV), Tao Capital Partners and Rising Tide VC.