The US Food and Drug Administration (FDA) has granted breakthrough device designation for Elucent Medical’s EnVisio X1 In-Body Spatial Intelligence System.
The solution enables real-time localisation and surgical guidance for the excision of soft tissue in cancer treatments and other diseases.
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Elucent noted that the EnVisio X1 is tailored for integration with current surgical procedures.
It also features SmartClip, a smart fiducial marker that can be positioned percutaneously or bronchoscopically. The company claims the marker is permanently implantable, offering flexibility in surgical planning and reducing scheduling challenges.
During surgical procedures, the EnVisio SmartSensor X is attached to a surgical stapler and performs wireless monitoring of SmartClip and the stapler location.
This provides surgeons with real-time 3D guidance for resection and margin control.
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By GlobalDataThe solution is especially beneficial for video and/or robotic-assisted surgeries, decreasing positive margins, and minimising the likelihood of re-excisions, leading to improved soft tissue excision outcomes of the thoracic and abdominal cavities.
Elucent Medical CEO Jason Pesterfield said: “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 localisation 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 EnVisio X1 platform is still in development and unavailable for sale or clinical usage in the US.
According to Elucent, the system will be used for localisation, non-imaging detection, and surgical navigation of the SmartClip, as well as tracking surgical instruments and other compatible tools, during soft tissue excision.
