Marginum, a Finnish medical technology company, has reached a major milestone with the announcement that its flagship device, HIVEN®, has been cleared for the CE mark under the European Union’s Medical Device Regulation (MDR). This certification, achieved in just over 4.5 years, marks one of the fastest paths to clearance for a breakthrough medical device of its kind. It positions HIVEN® as a pioneering solution in intraoperative tumour detection, with the potential to transform neurosurgical cancer care.
Accelerating Innovation in Neurosurgery
HIVEN® is a Class IIb medical device that introduces aspirate tissue monitoring (ATM) technology into neurosurgery. Its purpose is to provide near real-time feedback during operations, giving surgeons the ability to detect fluorescent tumour tissue directly from aspirated material without altering or complicating existing surgical workflows.
“Intraoperative tumour margin assessment has long been a significant challenge in neurosurgery,” explained Juho Leskinen, CTO and co-founder of Marginum. “Achieving clearance for the CE mark is a pivotal step in bringing HIVEN® into clinical practice and improving outcomes for patients in Europe. This certificate reflects the hard work of our team and the strength of our scientific and clinical foundations.”
The device has been designed to seamlessly integrate into established neurosurgical procedures, ensuring that its benefits do not come at the cost of longer operating times or additional complexity. By combining advanced fluorescence detection with aspirate tissue monitoring, HIVEN® provides what many experts believe could be a new standard for intraoperative precision.
Why It Matters: The Clinical Impact
Cancer surgery, particularly for aggressive brain tumours such as high-grade gliomas, is notoriously difficult. Surgeons face the constant challenge of removing as much cancerous tissue as possible while protecting surrounding healthy brain structures. Even with modern imaging and fluorescence-guided tools, complete tumour resection can be hindered by factors such as poor visibility, bleeding, or the presence of critical structures like blood vessels that obscure tumour margins.
This is where HIVEN® brings a unique advantage. By collecting and analysing aspirated tissue for fluorescence, it provides an additional stream of diagnostic feedback. This process helps surgeons identify cancerous cells hidden in blind spots or behind tissue ridges—areas where traditional visual inspection may fall short.
“In glioma surgery, our ability to distinguish tumour from healthier tissues is limited by anatomical constraints, blood, and compromised visibility, particularly in deep-seated areas,” said docent Antti-Pekka Elomaa, MD, PhD, consultant neurosurgeon and co-founder of Marginum. “We wanted HIVEN® to provide critical feedback beyond sensory limitations; you can consider it a sixth sense for tumour detection.”
Reducing Reoperations, Improving Outcomes
One of the most pressing issues in neurosurgical oncology is the high rate of reoperations. Patients often require additional surgeries due to incomplete removal of tumours, which increases risks, worsens long-term outcomes, and drives up healthcare costs. By offering surgeons more complete and objective data during the initial procedure, HIVEN® has the potential to reduce reoperation rates significantly.
The ability to more accurately define tumour margins also translates into greater preservation of healthy tissue. Sparing non-cancerous areas of the brain not only reduces immediate surgical risks but also improves recovery prospects and quality of life for patients. In this sense, HIVEN® represents a major step toward safer, more effective, and more personalized neurosurgical care.
Regulatory Success and Future Prospects
Marginum’s rapid achievement of MDR certification is itself noteworthy. Under the EU’s rigorous new regulatory framework, many companies have faced delays bringing medical devices to market. That HIVEN® cleared this process in just 4.5 years underscores both the robustness of its clinical validation and the urgency of addressing unmet needs in neurosurgery.
The approval covers the use of HIVEN® in fluorescence-guided neurosurgery for high-grade gliomas, a domain where precise margin identification is critical to improving survival rates. As adoption grows, the technology may also find applications in other types of cancer surgery, where intraoperative tissue assessment remains a challenge.
For Marginum, this milestone is not the end but the beginning of a broader journey. With CE mark clearance, the company can now begin introducing HIVEN® into clinical practice across Europe, working with hospitals and neurosurgical teams to integrate the device into daily operations. The long-term vision is to establish HIVEN® as a cornerstone technology in oncological surgery worldwide.
A New Era in Surgical Precision
The clearance of HIVEN® marks more than just a regulatory achievement—it represents a paradigm shift in how surgeons can approach tumour resection. By giving surgical teams a tool that effectively acts as an extra sense for detecting cancerous tissue, Marginum is opening the door to more complete resections, fewer complications, and better long-term outcomes for patients.
As healthcare systems continue to seek solutions that improve care while reducing costs, innovations like HIVEN® exemplify the role of medical technology in shaping the future of precision surgery. For patients facing the daunting diagnosis of high-grade gliomas, the arrival of this device offers new hope for safer, more effective treatment.
About Marginum:
Marginum, a leading innovator in fluorescence-guided oncological surgery, is a medical technology company developing fluorescence-based tissue detection systems. HIVEN® by Marginum enables safe and efficient monitoring of tumour tissues during cancer surgery. www.marginum.com
