FDA Grants Breakthrough Device Designation to EnVisio X1 for Minimally Invasive Surgery in Cancer Care

Breast Cancer | Image Credit:

© Sebastian Kaulitzki – stock.adobe.com

The FDA has granted breakthrough device designation to the EnVisio X1 In-Body Spatial Intelligence System—a next-generation localization platform— for the real-time, non-imaging detection, localization, and surgical navigation of the SmartClip soft tissue marker, tracked surgical instruments, and other compatible tools used for the surgical excision of soft tissue in patients with cancer and other diseases.1

The goal of the device is to enhance surgical precision, minimize positive margins, and reduce the need for re-excisions to improve outcomes for patients undergoing soft tissue excisions in the thoracic and abdominal cavities. EnVisio X1 provides surgeons with real-time, intraoperative localization of the SmartClip and precise positioning and tracking of surgical instruments in relation to the SmartClip and other navigational reference points.

The device is currently not available for commercial sale or clinical use in the United States.

“Receiving breakthrough device designation for EnVisio X1 is a pivotal milestone, not only for Elucent [Medical] but for the future of surgical care,” Jason Pesterfield, chief executive officer of Elucent Medical, stated in a news release. “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.”

EnVisio X1 is designed to be integrated into current surgical workflows. The SmartClip is a smart fiducial marker placed percutaneously or bronchoscopically that can be permanently implanted to allow for increased flexibility with the logistics of surgery. The SmartClip also has no minimum distance requirements, which could also improve the bracketing solution and allow for surgical approaches to start from any angle.2

When a patient undergoes surgery, the surgical stapler includes the EnVisio SmartSensor X, which tracks the location of the SmartClip and the stapler via real-time 3D guidance to aid in resection and margin control.1 EnVisio X1 is immune to interference from traditional surgical instruments, hematoma, air, or dense tissue, allowing for the device to maintain performance across various tissue types and malignancies.2 The system also provides a spatial field five times greater in depth compared with traditional localization methods.

The device was invented at the University of Wisconsin–Madison and developed by Elucent Medical with the goal of improving the efficiency of efficacy of surgery and decreasing patient stress.3 With current procedures, a small metal clip is left behind during biopsy to mark the location of a tumor, and during surgery, a radiologist will replace a hook wire through the skin to the biopsy clip to guide surgeons to the lesion.

With EnVisio X1, the SmartClip replaces the conventional metal clip, and it can be placed during the biopsy or at any time leading up to surgery. The SmartClip emits a high frequency signal when activated; by providing a continuous, real-time 3D image of the smart clip, surgeons can pick the safest, least disfiguring path to the tumor. Up to 3 SmartClips can be used for multiple targets or to bracket a single target.

In August 2024, Elucent Medical announced that it had partnered with Froedtert and the Medical College of Wisconsin health network to use its advanced in-body spatial intelligence systems for patients with breast cancer undergoing surgery.4

The breakthrough device designation from the FDA is intended to expedite patient access to innovative technologies that could provide improved treatment or diagnosis for life-threatening or irreversibly debilitating conditions.1 The designation opens the door for priority review and active collaboration with device developers to accelerate the path to approval and commercialization.

References

1. Elucent Medical receives FDA breakthrough device designation for EnVisio X1 In-Body Spatial Intelligence™ System. News release. Elucent Medical. May 15, 2025. Accessed May 22, 2025. https://www.globenewswire.com/news-release/2025/05/15/3082333/0/en/Elucent-Medical-Receives-FDA-Breakthrough-Device-Designation-for-EnVisio-X1-In-Body-Spatial-Intelligence-System.html
2. Technology. Elucent Medical. Accessed May 22, 2025. https://elucent.com/technology/
3. 75 years later, UW-Madison inventors aim to replace old-style breast-surgery marker. News release. University of Wisconsin–Madision. January 3, 2020. Accessed May 22, 2025. https://engineering.wisc.edu/news/75-years-later-uw-madison-inventors-aim-replace-old-style-breast-surgery-marker/
4. Elucent Medical announces Froedtert & the Medical College of Wisconsin health network to provide new breast cancer surgical technology. News release. Elucent Medical. August 9, 2024. Accessed May 22, 2025.