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.