jeris, FranceAnd the September 1, 2022 /PRNewswire/ — eCential Robotics, a French MedTech company that designs and produces a unified system for 2D/3D imaging, surgical navigation, and robotics, today announced that the Food and Drug Administration (FDA) has cleared 510(k) of its 3D imaging, navigation, and guidance system for robots, ensuring the penetration of Its unified robotic platform in United State.
Having recently partnered with US implant companies, eCential Robotics is henceforth aiming to reach the North American market.
Securing a plan to penetrate the US market in the medium term
eCential Robotics was created in 2009 by Stéphane Lavallée, President and Chairman of the Board of Directors, with the goal of enhancing the safety and accuracy of surgical procedures, while providing simplicity and speed of use. With the goal of enabling surgeons to work in a reliable and simple environment to achieve the best benefit for patients, eCential Robotics has focused its development on a unique and innovative concept: focusing surgical workflow on the essentials to make robot-assisted orthopedic surgery simple enough in the clinical routine to become a standard of care. eCential Robotics welcomes implant companies to create specific applications for multiple indications especially spine, cranial, trauma, orthopedics, sports medicine.
Historically, after several years of dedication to the massive development of its unique technology and workflow, eCential Robotics has received the CE Mark and successfully launched the commercialization of its first platform in France. Ten units were sold and installed in Europe And more than two thousand surgeries. To support North American market penetration, a subsidiary of eCential Robotics, Inc. was created. in December 2020. In the first quarter of 2022, eCential Robotics conducted pre-clinical evaluation tests at United States of America with neurosurgeons and orthopedic surgeons and contracted the first local application engineer. The FDA 510(k) clearance of the robotic intraoperative 2D and 3D imaging, navigation and guidance platform, with its first global application in spine surgery, now secures a plan to reach the North American market over the next few years.
“FDA’s authorization of the standardized eCential Robotics platform acknowledges the reliability and strength of our product, affirms confidence in eCential Robotics’ unique concept of focusing surgical workflows on the essentials across a unified, open, multi-application system, and also encourages our ambition to expand our footprint in United State“Ms. Lawrence Chapanas, Head of Strategy for eCential Robotics and . said: United States of America Executive Director. “This 510(k) is fundamental to our strategy. We are excited about these bold new, disruptive technologies and the role that eCential Robotics can play in reshaping orthopedic surgical procedures and restoring patients’ quality of life.” She added.
The eCential Robotics team will be exhibiting at the SMISS 2022 and NASS 2022 conferences in the US and displaying their robotic arm.
The only solution available is fully standardized
In its basic design, the eCential Robotics surgical platform unites 2D/3D imaging, navigation, and robotics. As the only available and completely standardized solution, it avoids the risks of traditional image-hopping coupling, such as unreliable calibration and recording steps, and simplifies the surgical workflow by automating many technical steps. A single user interface allows all devices to control imaging, navigation, and robotics functions from a single I/O graphic display. The system is also a completely open solution, which means that it can be used with implants of any manufacturer. The eCential Robotics platform is built around a set of applications (“Apps”) currently dedicated to spine surgery, and will expand in the future to include many orthopedic indications.
The Unified Open Platform is a medical device that provides 2D/3D medical imaging and stereotaxic guidance. The system consists of three interconnected mobile units: a mobile C-arm, a mobile display workstation, and a mobile collaborative robot. The mobile X-ray system is a five-axis imaging robot that supports 2D and 3D imaging of anatomical structures and high-contrast objects. Navigation with both free navigation and automated guidance, is based on the well-established standard approach of navigation systems using 3D optical location tracking technology, including a stereo camera, computer platform with screens, navigation software, robotic arm and tools equipped with specific fields to enable accurate translation in outer space.
“With huge potential for innovation, eCential Robotics simplifies the entire workflow for a seamless surgical experience,” announce David ArmandeCential Robotics CTO.
About eCential bots
eCential Robotics is a Grenoble-based company that specializes in surgical robotics. Develops and markets a unique system that unites automated 2D/3D imaging and real-time navigation. With 80 patents and seven trademarks, it pursues a disruptive innovation strategy. It provides orthopedic surgeons and neurosurgeons with advanced, user-friendly technology to visualize their operations, particularly minimally invasive surgery. The eCential Robotics platform is a global open system for all implants.
Winner of the Bpifrance Global Innovation Challenge in 2018, the company designs and produces all of its equipment in Grenoble, Franceincluding hardware and software. Please visit www.ecential-robotics.com Follow us on LinkedIn (eCential bots) and twitter (Tweet embed).
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