The Swedish MedTech company Multi4 Medical has received CE mark approval for the Multi4 System – a groundbreaking all-in-one technology that enables bladder cancer treatment during the same outpatient visit when cancer is detected, without operating room, anesthesia, or hospitalization.
GOTHENBURG, Sweden, May 5, 2026 /PRNewswire/ — The CE mark means the Multi4 System can now be deployed throughout Europe and marks a paradigm shift in urologic cancer care. With the world’s first all-in-one instrument, urologists can perform the entire treatment endoscopically on an awake patient – what typically requires a scheduled operation with anesthesia can now be completed in minutes during a routine office visit.
“The CE mark is a historic milestone for Multi4 Medical and for cancer care in Europe. The Multi4 instrument integrates all necessary functions into a single compact device and is the first system where cancer tissue is automatically transported out through the instrument itself and captured in a container. This makes treatment streamlined, safe, and feasible in an outpatient setting,” says Miden Melle-Hannah, urologist and CEO of Multi4 Medical.
All-in-one – From Detection to Treatment in Minutes
The Multi4 instrument’s unique design integrates multiple functions: local anesthesia is applied directly to the tumor, cancer tissue is precisely resected, tissue samples are automatically transported out through the instrument and collected in a container for pathology analysis. When needed, bleeding can be stopped and cancer tissue cauterized. The entire procedure is performed while the patient is awake and can go home immediately afterward – without general anesthesia, catheterization, or hospital admission.
Unlike today’s standard TURBT procedure, which requires an operating room and anesthesia with associated waiting times, Multi4 treatment can be performed immediately upon detection. This means shorter wait times for patients, reduced strain on operating departments, and lower cost per patient for healthcare systems. The system is supported by an established reimbursement code, facilitating adoption and implementation.
Clinical Validation at Sahlgrenska University Hospital
The CE mark is based in part on a clinical study conducted at Sahlgrenska University Hospital where 18 patients were successfully treated with the Multi4 System with excellent results.
“With the Multi4 System, we can transform the entire care pathway for bladder cancer patients – from scheduled hospital surgery to immediate outpatient treatment. We now look forward to offering Swedish patients treatment with the Multi4 System,” says Miden Melle-Hannah.
Global Expansion with FDA Clearance and CE Mark
Multi4 Medical has completed an exceptional regulatory journey over the past year. Following FDA clearance for the U.S. market earlier this year, the CE mark now opens the door for commercialization in Europe.
“Multi4 Medical is an excellent example of world-class Swedish medtech innovation. That the company now has both FDA clearance and CE mark demonstrates impressive execution capability. The Multi4 System has the potential to fundamentally transform cancer care by moving treatment from the operating room to outpatient care – creating value for patients, physicians, and healthcare systems simultaneously,” says Erik Selin, Chairman of the Board of Multi4 Medical.
Multi4 Medical has received numerous prestigious awards and recognitions, including winning Startup Company of the Year at Techarenan, receiving €2.5 million in support from the European Commission’s Innovation Council, and participating in the renowned global MedTech Innovator accelerator program.
For more information, contact:
Dr. Miden Melle-Hannah
Urologist, Surgeon, CEO, Multi4 Medical
+46 736 929 000
miden@multi4.se
About Multi4 Medical
Multi4 Medical is a Swedish medical technology company with a patented, automated technology for cancer diagnostics and treatment. The company’s first product, the Multi4 System, enables treatment of bladder cancer in an outpatient setting, without anesthesia or operating room. Multi4 Medical has received both FDA clearance and CE mark approval, and is a portfolio company of Erik Selin with headquarters in Gothenburg, Sweden. The technology can be applied to several other cancer types, and development of additional products is underway.
CONTACT:
Contact:
Miden Melle-Hannah
Urologist. Surgeon
CEO Multi4 Medical
+46736929000
https://www.multi4medical.com
linkedin.com/in/dr-miden-melle-hannah-8b7b7188
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Multi4 -first All-in-one device for cancer treatment |
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SOURCE Multi4 Medical
