Free Design Audit Available - Click Here for Details

TOOsonix receives MDR CE Mark for its new oncology and dermatology device

The EU Medical Device Regulation CE certification approves that the most common types of skin cancer and a wide range of skin diseases and conditions can be treated in less than 90 seconds.

COPENHAGEN, Denmark, May 30, 2024 /PRNewswire/ — TOOsonix A/S, a pioneer in high-intensity focused ultrasound (HIFU) technology for dermatology, has received EU Medical Device Regulation (MDR) CE certification for its system for image-guided dermatologic therapy.

The certification allows TOOsonix to sell its flagship product, System ONE-M™, across the European Economic Area. Treatment of skin cancer and skin diseases can now be conducted in ways never before possible, providing more patient-friendly treatment than traditional procedures.

“Our device presents oncologists and dermatologists with a new and versatile tool that can remove the need for an array of lasers, RF-devices, and other expensive specialized tools. With System ONE-M, a typical session may encompass the primary treatment of e.g. cancerous basal cell carcinoma, pre-cancerous actinic keratosis, as well as the removal of various more benign skin conditions that may have emerged since the patient’s last visit”, said Managing Director at TOOsonix, Torsten Bove.

Sign up for Blog Updates