Marginum, a Finnish medical technology company, has received CE mark clearance for its flagship HIVEN device for neurosurgery.

HIVEN is a novel device to assist in intraoperative margin assessment that offers near real-time feedback to support a safer and more complete tumor resection. The company made quick strides in the aspirate tissue monitoring (ATM) technique and achieved MDR certification in just over four and a half years.

The device offers immediate insight into tumor margins while resecting, aiming to improve outcomes and reduce the likelihood of reoperations. It detects fluorescent cancer tissue from aspirated tissue during surgery without disrupting workflow.

The aspirate tissue monitoring tech hopes to overcome surgical challenges that can damage healthy tissues and leave tumor cells undetected. Structures like blood vessels can create blind spots behind corners and tissue ridges where cancerous tissue can be tough to spot. HIVEN addresses this by letting resected tissue be transported directly for fluorescence analysis.

The HIVEN is approved for fluorescence-guided neurosurgery of high-grade gliomas, where precise identification of margins is crucial.

“Achieving clearance for the CE mark is a pivotal step in bringing the HIVEN into clinical practice and improving outcomes for patients in Europe,” said Marginum CTO and co-founder Juho Leskinen. “This certificate reflects the hard work of our team and the strength of our scientific and clinical foundations.”

“In glioma surgery, our ability to distinguish tumor from healthier tissues is limited by anatomical constraints, blood and compromised visibility, particularly in deep-seated areas,” added docent Antti-Pekka Elomaa MD, Ph.D., a consultant neurosurgeon and one of Marginum’s co-founders. “We wanted HIVEN to provide critical feedback beyond sensory limitations; you can consider it a sixth sense for tumor detection.”