Breakthrough in Cancer Care: Multi4 Medical’s New Technology Cleared by FDA

Swedish MedTech company Multi4 Medical, chaired by renowned investor Erik Selin, has received FDA clearance for its patended technology for automated cancer treatment. The decision means that Multi4 is now approved for commercial sale in the U.S., the world’s largest and most competitive healthcare market.

This regulatory milestone validates Multi4’s innovative approach to cancer care, offering treatments that can be completed in just minutes – without the need for general anesthesia, hospital admission, or long waiting times. Patients can now receive treatment during a regular outpatient visit, significantly reducing both healthcare costs and patient burden.

“This is a historic day for Multi4 Medical. FDA clearance confirms both the clinical strength and regulatory robustness of our technology. We are now ready to scale and deliver our solution to patients across the U.S. – with the goal of transforming cancer care through faster treatments, fewer hospital stays, and lower costs,” says Miden Melle-Hannah, CEO of Multi4 Medical.

Unlike conventional cancer treatments, which often require surgery under general anesthesia and inpatient care, Multi4 Medical has developed the world’s first automated technology that removes cancerous tissue directly through a multifunctional instrument. The system combines several functions in one device, enabling the entire procedure to be performed on an awake patient – who can return home immediately after the treatment. The initial focus is on bladder cancer.

“Receiving FDA clearance is a huge and important milestone, it shows that Multi4 Medical has both innovation and execution power. Our solution can save time and money for healthcare systems – while providing patients with immediate access to safe, non-invasive cancer treatment. This is just the beginning of a global commercialization journey,” says Erik Selin, Chairman of the Board at Multi4 Medical.

The FDA clearance opens the door to commercial partnerships and sales in the U.S., widely regarded as the most demanding regulatory environment for medical devices. The approved product is the result of years of development, supported by strong preclinical and clinical results.

Multi4 Medical was recently selected for MedTech Innovator 2025, the world’s leading accelerator for medtech startups, placing the company among the top 4% globally. Multi4 has also secured €2.5 million in funding from the European Innovation Council (EIC Accelerator).

In addition to its bladder cancer treatment platform, the company has initiated development of new diagnostic instruments for detecting early-stage cancers in the esophagus and colon, in collaboration with Karolinska University Hospital. Since its founding, Multi4 Medical has maintained strong strategic partnerships with Sahlgrenska University Hospital and RISE Research Institutes of Sweden, which have been critical to the development and validation of its technology.

About Multi4 Medical

Multi4 Medical is a Swedish MedTech company with a patented, automated solution for cancer diagnosis and treatment. The company is initially focusing on bladder cancer, with potential applications across multiple cancer types in the future. Multi4 Medical is backed by Erik Selin and headquartered in Gothenburg, Sweden.