Elucent Medical, a medical technology company headquartered in Eden Prairie, has received Breakthrough Device Designation from the U.S. Food and Drug Administration for its EnVisio X1 In-Body Spatial Intelligence System.
Designed to integrate with existing surgical workflow, the EnVisio X1 system features a marker called the SmartClip, which can be placed either percutaneously (through the skin) or bronchoscopically (via airways). Unlike traditional localization methods, SmartClips are permanently implantable.
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 surgical navigation of the SmartClip soft tissue marker, tracked surgical instruments, and other compatible tools used in the excision of soft tissue.
This can be valuable in both video- and robotic-assisted surgeries, offering the potential to enhance surgical precision 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.
“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,” Pesterfield said.
The FDA Breakthrough Device Designation is intended to expedite patient access to innovative technologies that may offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. Through this program, the FDA offers priority review and active collaboration with device developers – from early clinical trial planning through regulatory approval – to accelerate the path to commercialization.
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