Elucent’s EnVisio X1 System receives Breakthrough Status from FDA

The FDA has awarded Breakthrough Device Designation to Elucent Medical’s EnVisio X1 In-Body Spatial Intelligence System, which is still in development and not yet approved for clinical use in the US. Designed for real-time localization and surgical guidance, the platform aids in soft tissue excision for cancer and other conditions. It includes SmartClip, a permanently implantable marker placed percutaneously or bronchoscopically, offering flexible surgical planning. The SmartSensor X, wirelessly attached to a surgical stapler, provides 3D intraoperative guidance to enhance precision and margin control. EnVisio X1 supports video and robotic-assisted surgeries, helping reduce re-excisions and improve outcomes in thoracic and abdominal procedures. The system will also facilitate non-imaging detection and navigation of SmartClip and compatible surgical instruments.

24-05-2025