Elucent Medical, a leading innovator in the field of guided surgical technologies, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the EnVisio X1 In-Body Spatial Intelligence System.
As part of Elucent’s mission to lead innovation in real-time localisation and surgical guidance for soft tissue excision in the treatment of cancer and other diseases, the EnVisio X1 platform sets a new standard in surgical precision and patient-focused care.
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Designed to integrate with existing surgical workflow, the EnVisio X1 System features a ‘smart’ fiducial marker called the SmartClip, which can be placed either percutaneously or bronchoscopically. Unlike traditional localisation methods, SmartClips are permanently implantable, providing greater flexibility in scheduling and reducing logistical hurdles. During surgery, the EnVisio SmartSensor X is attached to a surgical stapler and wirelessly tracks the location of both the SmartClip and the surgical stapler, enabling real-time 3D guidance for resection and margin control. This level of intraoperative intelligence can be valuable in both video and/or robotic-assisted surgeries. This groundbreaking technology has the potential to enhance surgical precision, minimise positive margins and reduce the need for re-excisions – ultimately improving outcomes in soft tissue excisions of the thoracic and abdominal cavities. The EnVisio X1 platform is currently under development and has not been cleared by the FDA. It is not available for commercial sale or clinical use in the United States.
Cancer remains one of the leading causes of mortality worldwide, with soft tissue cancers such as lung, liver, colorectal, and lymphatic cancers among the most common and life-threatening forms. These cancers are often aggressive, with poor survival rates when diagnosed at advanced stages. In the United States, only a fraction of cases are diagnosed at an early stage. Late detection often results in disease progression, making treatment more complex and reducing the chances of survival.
“Receiving Breakthrough Device Designation for EnVisio X1 is a pivotal milestone, not only for Elucent but for the future of surgical care,” said Jason Pesterfield, CEO of Elucent Medical. “This recognition reinforces the urgency and potential of our technology to transform the current standard of care by empowering surgeons with real-time localization and surgical navigation tools. Our goal is to redefine what’s possible in minimally invasive surgery—helping patients receive more precise, less invasive interventions that can truly change lives.”
