Marginum Secures First-of-its-Kind Approval for HIVEN® Neurosurgery Device

Finnish medical technology company Marginum has reached a major milestone as its flagship device, HIVEN®, receives CE mark clearance. 

The certification under the Medical Device Regulation (MDR) marks an important step towards clinical use in Europe.

The company achieved rapid progress in validating its aspirate tissue monitoring (ATM) technology, completing the process in just over 4.5 years—a record speed for a class IIb medical device. 

HIVEN® is designed to address a critical unmet need in neurosurgery: accurately detecting tumour tissue during operations without disrupting standard surgical workflows.

HIVEN® is a novel device that assists surgeons with intraoperative margin assessment by providing near real-time feedback. 

It helps surgical teams identify tumour margins during resection, aiming to improve patient outcomes and reduce the need for repeat operations. 

The device detects fluorescent cancer tissue from aspirated samples, delivering critical information without interfering with normal procedures.

The ATM technology helps overcome challenges where healthy tissue may be damaged or tumour cells missed, which can lead to incomplete tumour removal and long-term complications. 

By analysing aspirated tissue for fluorescence, HIVEN® provides a more complete view of the surgical site, including areas that are difficult to see due to blood, tissue ridges, or anatomical constraints.

The device enhances surgical precision, simplifies workflow, and allows objective tissue identification in hard-to-reach regions, supporting safer and more effective tumour removal.