What's Happening?
Marginum, a Finnish medical technology company, has announced that its flagship device, HIVEN®, has been cleared for the CE mark. This clearance marks a significant regulatory milestone for the company. The HIVEN® device is designed to assist in intraoperative margin assessment during cancer surgeries, providing near real-time feedback to surgeons. This innovation aims to improve patient outcomes by enabling more precise tumor resections and reducing the likelihood of reoperations. The device uses fluorescence-guided technology to detect cancerous tissue during surgery without disrupting standard workflows.
Why It's Important?
The clearance of the HIVEN® device for the CE mark is a pivotal step in advancing cancer surgery techniques. By providing surgeons with immediate insights into tumor margins, the device enhances surgical accuracy and patient safety. This development is particularly significant for neurosurgery, where precise margin identification is critical. The device's ability to detect cancerous tissue in hard-to-reach areas could lead to fewer reoperations and better long-term outcomes for patients. The innovation reflects Marginum's commitment to addressing unmet clinical needs in oncological surgery.