FDA clears Activ Surgical hardware for enhanced surgical visualization

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Activ Surgical announced today that it’s won FDA 510(k) clearance for ActivSight, the company’s intraoperative imaging module for enhanced surgical visualization.

Todd Usen, the Boston-based company’s CEO, described the clearance as “big news” in a LinkedIn post. “This clearance gets us one step closer to bringing our technology to ORs around the world and enabling real-time and best-in-class surgery for everyone,” Usen said.

The hardware-agnostic imaging module provides surgeons with real-time intraoperative visual data and imaging. Thirteen major healthcare systems around the world have so far committed to ActivSight’s initial launch, according to Activ Surgical. The company expects to launch ActivSight during the second half of 2021.

Activ Surgical plans for ActivSight to power its next product — ActivInsights. Included in the ActivEdge software platform, ActivInsights will use artificial intelligence and machine learning to produce surgical insights. The first ActivInsight will involve perfusion insights, with the ability to see blood flow and perfusion in real-time without 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,” Activ Surgical founder and CSMO Dr. Peter Kim said in a news release. “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.”

APRIL 9, 2021 BY CHRIS NEWMARKER

https://www.massdevice.com/fda-clears-activ-surgical-hardware-for-enhanced-surgical-visualization/​