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Home » FDA clears Activ Surgical hardware for enhanced surgical visualization

FDA clears Activ Surgical hardware for enhanced surgical visualization

April 9, 2021 By Chris Newmarker

ActivSight surgical imaging module Activ Surgical
[Image courtesy of Activ Surgical]
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.”

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Health Technology, Imaging, Regulatory/Compliance, Software / IT, Surgical Tagged With: Activ Surgical, AI, artificial intelligence

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About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at [email protected].

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