Regulatory

Activ Surgical Announces FDA Clearance for ActivSight Intraoperative Imaging Module for Enhanced Surgical Visualization

BOSTON, April 9, 2021 /PRNewswire/ — Activ Surgical™, a digital surgery pioneer, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s ActivSight™ Intraoperative Imaging Module for enhanced surgical visualization. The hardware agnostic imaging module has been designed to provide surgeons real-time intraoperative visual data and imaging not currently available to surgeons through existing technologies, helping to improve patient outcomes and safety in the operating room.

“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,” said Todd Usen, CEO of Activ Surgical. “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, and will offer the ability to see blood flow and perfusion in real time, without the use of 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,” said Dr. Peter Kim, Founder and CSMO, Activ Surgical. “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.”

To date, 13 major healthcare systems around the world have committed to ActivSight’s initial launch, which is planned for the second half of 2021. For more information on Activ Surgical and its technologies, please visit https://www.activsurgical.com/#about.

About Activ Surgical  
Activ Surgical, the company that completed the world’s first autonomous robotic surgery of soft tissue, is building hardware-agnostic surgical software that allows surgical systems to collaborate with surgeons. Activ Surgical’s patent-protected surgical software platform reduces unintended and preventable surgical complications by enhancing a surgeon’s intra-operative decision making. Activ Surgical is privately held, and backed by DNS Capital, GreatPoint Ventures (GPV), Artis Ventures, Tao Capital Partners, LRVHealth, Rising Tide VC, SONY Innovation Fund and 8VC. More information can be found atwww.activsurgical.com.

SOURCE Activ Surgical

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Chris J. Stewart

Chris currently serves as President and CEO of Surgio Health. Chris has close to 20 years of healthcare management experience, with an infinity to improve healthcare delivery through the development and implementation of innovative solutions that result in improved efficiencies, reduction of unnecessary financial & clinical variation, and help achieve better patient outcomes. Previously, Chris was assistant vice president and business unit leader for HPG/HCA. He has presented at numerous healthcare forums on topics that include disruptive innovation, physician engagement, shifting reimbursement models, cost per clinical episode and the future of supply chain delivery.

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