Ultrasound technology developer TOOsonix has obtained the European Union (EU) Medical Device Regulation (MDR) CE certification for its System ONE-M.
System ONE-M is an image-guided oncology and dermatology device.
The certification authorises TOOsonix to distribute its lead product throughout the European Economic Area.
The device has been designed to treat the most common types of skin cancer and a vast range of skin diseases in less than 90 seconds. It is said to offer patients more comfortable treatment options compared to conventional dermatological procedures.
TOOsonix said that the image-guided therapy can treat all procedures in a single, streamlined session using a single device.
In addition, System ONE-M has integrated imaging capability to examine the target lesion area in microscopic detail before treatment, ensuring precise, image-guided treatment.
TOOsonix managing director Torsten Bove said: “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 specialised 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.”
The device is approved for various subcategories within dermatology. In oncology, it is cleared to treat basal cell carcinoma and actinic keratosis, a pre-cancerous condition.
Additionally, System ONE-M delivers a non-invasive treatment for cutaneous neurofibromas in patients with Neurofibromatosis Type 1, a rare genetic disorder.
Furthermore, it can treat a broad spectrum of benign skin tumours and neoplasms within general dermatology, said TOOsonix.
The ultrasound technology developer claimed that the clinical data for all treatments demonstrate safe, rapid, and effective therapies.
Patients now have access to non-invasive options with minimal discomfort and no downtime post-treatment, as well as no side effects from pharmaceutical agents or harmful radiation.
