miraDry® Secures EU MDR Certification
MiraDry®, a leading company in the treatment of underarm sweat and odor, is proud to announce that it has successfully obtained CE marking for its miraDry system under the European Union's Medical Device Regulation (EU MDR 2017/745). This significant achievement also comes with heightened clearance for addressing sweat reduction, odor control, and hair removal services across Europe.
Improvements in Treatment Efficiency
In addition to the CE marking, miraDry has introduced new software to its treatment system, promising a reduction of total treatment times by up to 30%. This enhancement not only improves patient comfort but also boosts clinic efficiency, providing a better overall experience for both patients and practitioners.
Expanding Reach in Europe
Now, miraDry is available through hundreds of providers in over 14 European countries, with the company having treated more than 500,000 patients globally. This certification reflects the company’s ongoing commitment to deliver high-quality, innovative solutions that cater to the increasing demand for effective underarm treatments in the region.
Insights from Leadership
Robert Catlin, the Chief Executive Officer of miraDry, expressed, "Securing CE mark under the new MDR process, with expanded indications for the miraDry system reflects our commitment to high-quality innovation. We are proud to deliver a long-term, proven solution to address the growing demand for underarm sweat, odor, and hair reduction in Europe—while driving value for providers."
The Growing Market
The demand for effective underarm solutions is rising significantly. According to market projections, Europe's deodorant market is expected to reach a staggering $16.15 billion by 2031, with more than 50 million consumers in the UK using deodorants regularly. Additionally, the laser hair removal market in Europe is forecasted to grow to $1.22 billion by 2032, with underarms being one of the most commonly treated areas.
Irene Mo, Vice President of Quality and Regulatory at miraDry, noted, "This certification underscores miraDry's clinical performance and regulatory strength. We have built a technology that meets rigorous international standards and safely delivers long-lasting relief from sweat, odor, and hair."
Unique Benefits of miraDry
MiraDry stands out as the only FDA-cleared and CE-marked system specifically designed for the permanent reduction of sweat, odor, and hair follicles. The miraDry system continues to demonstrate its efficacy with studies showing that it can reduce odor in 97% of treated underarms, while 89% of patients reported no longer being bothered by underarm odor. Its patented technology is effective across different skin tones and types, achieving a 70% reduction in hair for various skin Fitzpatrick types.
Conclusion
As it expands across Europe, miraDry remains dedicated to providing innovative, non-surgical solutions for excessive underarm sweat, odor, and hair. With a commitment to patient satisfaction—currently at 90%—and a proven track record of more than 500,000 treatments, miraDry is solidifying its place as a leader in the medical aesthetics market. For more information, visit
miraDry.com.