Elucent Medical, a US-based guided surgical technology company, has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its EnVisio X1 In-Body Spatial Intelligence System.
The announcement marks a significant step in Elucent’s efforts to advance real-time localisation and surgical guidance technologies for soft tissue excision, particularly in cancer treatment.
The EnVisio X1 System, which aims to enhance surgical precision and patient care, seamlessly integrates with current surgical workflows.
It includes the SmartClip, a ‘smart’ fiducial marker that can be implanted percutaneously or bronchoscopically. Unlike conventional methods, SmartClips remain permanently in place, offering increased scheduling flexibility and reducing logistical challenges.
During surgical procedures, the EnVisio SmartSensor X attaches to a surgical stapler, wirelessly tracking the positions of both the SmartClip and the stapler. This setup provides real-time 3D guidance for resection and margin control, which is particularly useful in video and robotic-assisted surgeries.
The technology is designed to improve surgical accuracy, decrease positive margins, and lower the likelihood of re-excisions, thereby enhancing outcomes in soft tissue excisions within the thoracic and abdominal areas.
Currently under development, the EnVisio X1 platform has not yet received FDA clearance and is not available for commercial sale or clinical use in the US.
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.”
Earlier this year, Trinity Capital, an alternative asset management firm, announced a $30m commitment in growth capital to Elucent Medical.
