Elucent Medical Receives FDA Breakthrough Device Designation for EnVisio X1™ In-Body Spatial Intelligence™ System

Next-generation localization platform marks paradigm shift in minimally invasive surgery, elevating precision in cancer care

MINNEAPOLIS, May 15, 2025 (GLOBE NEWSWIRE) -- Elucent Medical (“Elucent”), 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 localization 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.

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 localization 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, minimize 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."

The FDA Breakthrough Device Designation is designed 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.

The EnVisio X1 System is indicated for 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. The system provides accurate real time intraoperative localization of the SmartClip and enables precise positioning and tracking of surgical instruments relative to the SmartClip and other navigational reference points.

ABOUT ELUCENT MEDICAL
Elucent Medical is a leading innovator in the field of guided surgical technologies, dedicated to improving patient outcomes through precision and accuracy. The company's flagship technologies, EnVisio® and SmartClip, offer groundbreaking solutions for soft-tissue surgical guidance with In-Body Spatial Intelligence (iSi). With a commitment to innovation and collaboration, Elucent Medical is driving advancements in surgical oncologic care, making a positive impact on the lives of patients and the medical professionals who treat them.

For more information about Elucent Medical and its innovative solutions, please visit www.elucent.com.

TRADEMARKS
Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Elucent Medical and its subsidiaries in the United States and other jurisdictions.

CONTACTS
PR/Media Inquiries
Lejla Breckenkamp
Elucent Medical
(844) 417-1700
Lejla.Breckenkamp@Elucent.com