Elucent Medical announced today that it received FDA breakthrough device designation for its EnVisio X1 In-Body Spatial Intelligence system.
Minneapolis-based Elucent designed EnVisio X1 to set “a new standard in surgical precision and patient-focused care.” It delivers real-time localization and surgical guidance for soft tissue excision in the treatment of cancer and other diseases.
The company says EnVisio X1 integrates with existing surgical workflows, featuring a “smart” fiducial marker called the SmartClip. SmartClip can be placed either percutaneously or bronchoscopically and are permanently implantable, providing greater felexibility in scheduling and reducing logistical hurdles compared to traditional localization methods.
During surgery, the EnVisio SmartSensor X attaches to a surgical stapler, wirelessly tracking the Smart Clip and stapler location. This enables real-time 3D guidance for resection and margin control. Elucent Medical says this intraoperative intelligence can prove valuable in both video- and/or robotic-assisted surgeries.
EnVisio X1 remains under development and not cleared for commercial sale or clinical use in the U.S.
“Receiving breakthrough device designation for EnVisio X1 is a pivotal milestone, not only for Elucent but for the future of surgical care. 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,” said Jason Pesterfield, CEO of Elucent Medical. “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.”
