Ultrasound tech manufacturer TOOsonix A/S announced that it has received EU Medical Device Regulation (MDR) CE certification for its image-guided dermatologic therapy system, System ONE-M™, according to a news release from the company.

The device facilitates the treatment of common skin cancers and a wide range of skin diseases in less than 90 seconds, offering a more patient-friendly alternative to traditional procedures. System ONE-M™ combines high-precision image-guided therapy with HIFU, allowing clinicians to assess and treat target lesions with extreme accuracy in a single session. This approach eliminates the need for multiple specialized tools, such as lasers and RF-devices. The new certification enables TOOsonix to market and sell System ONE-M™ across the European Economic Area.

“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, said Torsten Bove (pictured, left), managing director at TOOsonix, said in a press release. "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 integrated imaging capability of System ONE-M™ enables clinicians to view target areas in microscopic resolution before treatment, ensuring precise and effective therapy. Tomasz Zawada, co-managing director at TOOsonix (pictured, right), emphasized the patient-friendly nature of the treatment, noting that it requires no downtime and leaves patients virtually unaffected post-procedure.

“The treatment allows patients to depart virtually unaffected and without requiring downtime," he said. "Our objective has been to provide the most patient friendly treatment. TOOsonix System ONE-M is the next-level device for treatment of the skin"

The approved treatments include interventions for basal cell carcinoma and actinic keratosis, non-invasive treatment of cutaneous neurofibromas in Neurofibromatosis Type 1, and a variety of benign skin tumors and neoplasms. These conditions are commonly treated with lasers, light therapies, RF-therapy, cryotherapy, and various pharmaceutical products.

Lone Schøtt Kunøe, CEO of Consolidated Holdings A/S and Chairman of TOOsonix, expressed optimism about the device's potential.

"The CE mark signifies the initial breakthrough for TOOsonix in the market, heralding a promising future for both medical and aesthetic dermatological therapy," he said in a press release. 

Source: TOOsonix A/S news release. May 28, 2024.