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Activ Surgical Announces Completion of First AI-Enabled Case Using Its ActivSight™Intelligent Light
Digital surgery pioneer uses proprietary colorectal artificial intelligence mode during surgical procedure at The Ohio State University Wexner Medical Center.
BOSTON – January 9, 2023 — Activ Surgical, a digital surgery pioneer, today announced that it has completed its first artificial intelligence (AI)-enabled case using its product, ActivSight™ Intelligent Light (ActivSight), which aims to provide enhanced visualization and real-time, on-demand surgical insights in the operating room. ActivSight is an easy-to-adapt module that seamlessly attaches to today’s laparoscopic and robotic systems and integrates with standard monitors. On December 22, 2022, Matthew Kalady, MD, FASCRS, Chief of the Division of Colon and Rectal Surgery at The Ohio State University Wexner Medical Center, performed a laparoscopic left colectomy, which is the surgical removal of the left side of the large bowel most often due to colon cancer, using the colorectal AI mode within ActivSight. Activ Surgical is currently conducting a clinical study with Ohio State Wexner Medical Center to evaluate the utility and usability of ActivSight.
“While using one of ActivSight’s intraoperative visual overlays, the dye-free ActivPerfusion™ Mode, I was able to clearly see key critical structures in the surgical site and tissue perfusion in real-time,” said Dr. Kalady. “With the press of a button, the colorectal AI mode was enabled, removing distractions of background signals from non-bowel tissue and clearly focusing on perfusion to the colon. There was a clear difference in visualization during AI mode.”
In ActivPerfusion Mode, the device uses laser speckle technology on the entire view to show blood perfusion. Once enabled, the colorectal AI mode isolates the ActivPerfusion display to the targeted tissue, in this case, the colon, to minimize cognitive burden for the surgeon by eliminating the distraction of seeing blood perfusion in the entire scene.
“At Activ Surgical, we are driven to learn from every procedure using enhanced, real-time visualization capabilities combined with augmented reality, artificial intelligence and machine learning technology so that we can deliver intelligent information to doctors around the world to reduce surgical complication rates,” said Manisha Shah-Bugaj, Chief Executive Officer at Activ Surgical. “With this latest milestone, we usher in a new standard of patient care and safety and will continue to build on our progress using AI technology.”
Activ Surgical is transforming the operating room today through its 501(k)-cleared ActivSight that seamlessly upgrades existing operating room equipment while serving as the “eyes” of their ActivEdge platform. With ActivSight, surgeons can now access critical intraoperative visual data as augmented reality overlays. In 2021, the ActivSight module was cleared by the FDA and successfully used in first-in-human/IRB studies. To date, multiple major hospital networks across the U.S. and Europe have been established as pilot sites. In 2022, ActivSight received CE Mark approval, which validates that it meets the requirements of the European Medical Devices Regulation, allowing Activ Surgical to commercialize the enhanced imaging system across the European Union and other CE Mark-required regions.
“With this procedure, we have shown that we can deploy proprietary models that have been trained with our datasets, annotated with our experts and our pipeline, and developed with our team and partners,” said Shah-Bugaj. “We are collaborating with global technology leaders to assist us with optimizing storage, integration, and inference. When all of this advanced tech is installed in the OR, our novel sensing brings it to life, and the results are incredible.”
About Activ Surgical
Activ Surgical is the pioneering digital surgery company that completed the world’s first autonomous robotic surgery of soft tissue in 2018. The company aims to transform the collective surgical experience by leveraging emerging technologies and data into insights that make world-class surgery accessible for all, and for every surgical imaging system to deliver intelligent information that reduces surgical complication rates, ushering in a new standard of patient care and safety. Activ Surgical is privately held, and backed by Cota Capital, BAM Funds, Hikma Ventures, Mint Ventures, Castor Ventures, Dream One Vision, NVIDIA, DNS Capital, GreatPoint Ventures (GPV), Artis Ventures, Tao Capital Partners, LRVHealth, Rising Tide VC, SONY Innovation Fund, 8VC, Fiscus Ventures, Peak 6 and Reimagined Ventures. Learn more at activsurgical.com and follow us on LinkedIn and Twitter.
Activ Surgical Appoints Manisha Shah-Bugaj as Chief Executive Officer
BOSTON – December 14, 2022 — Activ Surgical, a digital surgery pioneer, today announced that it has named Manisha Shah-Bugaj as its new Chief Executive Officer. Shah-Bugaj has served as Activ Surgical’s Chief Operating Officer since January 2022, leading the Company’s impending global commercialization efforts around its first product, ActivSight™ Intelligent Light, which aims to provide enhanced visualization and real-time, on-demand surgical insights in the operating room. In her expanded role as CEO, Shah-Bugaj will oversee the ongoing development and commercialization of Activ Surgical products and engage with company partners, customers, and investors. Activ Surgical’s outgoing CEO, Todd Usen, will remain on the Company’s Board of Directors.
Prior to joining Activ Surgical, Shah-Bugaj architected the gynecology unit at Olympus from the ground up in the U.S., ultimately serving as General Manager and Global Vice President for the company, and played an integral role in expanding the gynecology business internationally. She has more than two decades of experience, including building and implementing corporate business plans, directing regional and global businesses aligned to financial and operational targets, hiring and establishing new teams, and managing product portfolios.
“Manisha is the perfect leader to take on the CEO position as Activ Surgical pivots from primarily a research and product development organization to commercialization of the Company’s products,” said Paul Meister, chairman, board of directors, Activ Surgical. “She has an impressive track record as a successful medtech executive and transformational operationally-focused leader with deep expertise in commercializing complex technologies and scaling businesses to meet a wide range of customer needs. I look forward to continuing our close working relationship and am excited about the possibilities for Activ Surgical with Manisha in this leadership role.”
“I am honored to follow in Todd’s footsteps and lead our extraordinarily talented team as the next CEO of Activ Surgical,” said Shah-Bugaj. “My passion for developing cutting-edge technologies that solve the biggest challenges in healthcare, coupled with my experience in commercializing and scaling new medtech products and systems, has led me to this career-defining moment. I am humbled and grateful for the opportunity to lead Activ Surgical into this new chapter of our history as we aim to usher in a new era of patient safety and surgical care in operating rooms around the world.”
For more information about Activ Surgical and its technology, please visit www.activsurgical.com.
About Activ Surgical
Activ Surgical is the pioneering digital surgery company that completed the world’s first autonomous robotic surgery of soft tissue in 2018. The company aims to transform the collective surgical experience by leveraging emerging technologies and data into insights that make world-class surgery accessible for all, and for every surgical imaging system to deliver intelligent information that reduces surgical complication rates, ushering in a new standard of patient care and safety. Activ Surgical is privately held, and backed by Cota Capital, BAM Funds, Hikma Ventures, Mint Ventures, Castor Ventures, Dream One Vision, NVIDIA, DNS Capital, GreatPoint Ventures (GPV), Artis Ventures, Tao Capital Partners, LRVHealth, Rising Tide VC, SONY Innovation Fund, 8VC, Fiscus Ventures, Peak 6 and Reimagined Ventures. Learn more at www.activsurgical.com.
Activ Surgical Secures CE Mark Approval for ActivSight™ Intelligent Light
BOSTON – December 6, 2022 — Activ Surgical, a digital surgery pioneer, today announced that it is has received CE Mark approval for its ActivSight™ Intelligent Light (“ActivSight”). The CE Mark validates that ActivSight meets the requirements of the European Medical Devices Regulation, allowing Activ Surgical to commercialize the enhanced imaging system across the European Union and other CE Mark required regions.
ActivSight is an easy-to-adapt module that seamlessly attaches to today’s laparoscopic systems providing real-time, on-demand surgical insights integrated into standard monitors. It is the first and only modular form-factor with multimodal Advanced Visualization for minimally invasive surgery. With ActivSight, surgeons can access critical intraoperative visual data as augmented reality overlays, helping to increase surgical outcomes and patient safety.
“As an early clinical advisor in the development of ActivSight Intelligent Light, I have seen first-hand the benefits it can provide me and my fellow surgeons in operating rooms around the world,” said Nicole Bouvy, surgeon and professor at Maastricht University Medical Center (MUMC+), The Netherlands. “The system is seamless to use and allows for advanced visualization during surgery, which makes it an important additional tool to potentially reduce surgical complications. I am pleased that Activ Surgical obtained the CE Mark today for ActivSight.”
“Patient safety is my number one priority in the operating room,” said Hans Fuchs, professor of surgery and head of robotic surgery for the department of surgery at the University of Cologne. “Activ Surgical is on the leading edge when it comes to enhancing surgical vision and significantly reducing unintended medical errors, and I am confident that ActivSight will improve surgical outcomes.”
“The team at Activ Surgical is thrilled to achieve the CE Mark for ActivSight in the European Union and beyond,” said Todd Usen, CEO, Activ Surgical. “This clearance represents a momentous step forward for the company as we execute against our global commercialization strategy for the system. We believe ActivSight will be a game-changer in the operating room by revolutionizing surgical vision and, ultimately, improving surgical care and patient safety. This is a proud day in Activ Surgical’s history.”
Activ Surgical received 510(k)-clearance for ActivSight by the Food and Drug Administration (FDA) in the United States in 2021. To date, multiple major hospital networks across the U.S. and Europe have been established as pilot sites for ActivSight, which has already seen successful clinical use in over 200 patients and multiple in-human IRB studies.
For more information about Activ Surgical and ActivSight Intelligent Light, please visit www.activsurgical.com.
About Activ Surgical
Activ Surgical is the pioneering digital surgery company that completed the world’s first autonomous robotic surgery of soft tissue in 2018. The company aims to transform the collective surgical experience by leveraging emerging technologies and data into insights that make world-class surgery accessible for all, and for every surgical imaging system to deliver intelligent information that reduces surgical complication rates, ushering in a new standard of patient care and safety. Activ Surgical is privately held, and backed by Cota Capital, BAM Funds, Magnetar Capital, Hikma Ventures, Mint Ventures, Castor Ventures, Dream One Vision, NVIDIA, DNS Capital, GreatPoint Ventures (GPV), Artis Ventures, Tao Capital Partners, LRVHealth, Rising Tide VC, SONY Innovation Fund and 8VC. Learn more at www.activsurgical.com.