DERMUS crowns a remarkable series of success with MDR (CE) Certification

Reflecting back on 2024, BHH member Dermus has reached significant regulatory and commercial milestones and closed a prosperous year.

The company’s flagship product, Dermus SkinScanner-M v.1.0 (“SSM”), is now an MDR Class IIa medical device. SSM stands out as the first ultrasound device in the world to integrate simultaneous optical imaging, allowing doctors to see both the depth and the surface of the skin in real-time (e.g. centre of melanoma). Additionally, it is the highest frequency handheld ultrasound device in the market, allowing high resolution skin imaging in a point of care setting. Preparing for a US presence, the company has submitted documentation for the FDA clearance too.

Furthermore, Dermus completed the UCB’s Digital Care Transformation Startup Program (DCTx), where UCB provided tailored mentorship sessions with industry experts to help create a solution that enables faster and more accurate hidradenitis suppurativa diagnoses. Over 300 companies were mapped and 4 were chosen to participate in the program. At the closing pitch competition, CEO Miklós Gyöngy received the Best Pitch Award.

In addition, Dermus announced a new collaboration with the esteemed Mayo Clinic, a globally recognized leader in healthcare and research, to develop advanced cancer imaging solutions combining Dermus' technology with Mayo Clinic’s clinical expertise.

The company is currently raising €5 million to support global sales. Part of this eort Dermus has already expanded product availability to North America (the United States and Canada), Europe (Poland and France), and the Middle East (Kuwait, Egypt, the United Arab Emirates and Saudi Arabia) through newly formed distribution partnerships. Dermus will begin 2025 by attending the IMCAS World Congress in Paris, one of the world’s leading event for aesthetics medicine.

These achievements highlight years of dedicated commitment to advancing medical imaging technology and improving patient care worldwide. Dermus extends its gratitude to its team, partners, and collaborators for their contributions to this remarkable series of progress.

Discover more about Dermus at their website HERE.