We are thrilled to announce that our revolutionary System ONE-M™ has been awarded CE certification according to the European Medical Device Regulation.

This innovative device utilizes high-intensity focused ultrasound (HIFU) technology to treat common skin cancers and a wide range of dermatological diseases and conditions, typically in a single session taking under 90 seconds.

Key Benefits:

    • Versatile – Replaces multiple specialized tools for comprehensive skin treatments.
    • Efficient – Sessions last less than 90 seconds with high efficacy, low pain, and no downtime.
    • Precise – Integrated imaging ensures high-precision, real-time, image-guided therapy.

This approval facilitates regular treatment of almost any non-metastasizing skin disease, ranging from basal cell carcinoma (the most common cancer worldwide), actinic keratosis (the most common pre-cancer worldwide), cutaneous neurofibromas (a tumor developing in patients with the most common genetic disorder worldwide), and an almost endless number of other skin diseases and conditions that affects hundreds of million people around the world.

This is a game-changer for dermatologists and oncologists, enhancing patient care significantly.

Discover more about this breakthrough in our Press Release.

Read more about the System ONE-M device and its approved use here.