miraDry® Secures EU MDR Certification and Expands Indications for Sweat, Odor, and Hair Reduction Across Europe
NEWPORT BEACH, Calif., July 10, 2025 /PRNewswire/ -- miraDry®, Inc., a global leader in underarm sweat and odor treatment, announced today it has now obtained CE marking for the miraDry system, under the European Union's Medical Device Regulation (EU MDR 2017/745), along with expanded clearance for the reduction of underarm sweat, odor, and hair. The company also gained approval for software that reduces total treatment time by up to 30%, enhancing both patient comfort and clinic efficiency.
miraDry is now offered by hundreds of providers in 14+ European countries and has helped over 500,000 patients globally. With this clearance, miraDry provides a faster, more complete solution to three of the most common underarm concerns, in one non-surgical treatment.
"Securing CE mark under the new MDR process, with expanded indications for the miraDry system reflects our commitment to high-quality innovation," said Robert Catlin, Chief Executive Officer, miraDry. "We're proud to deliver a long-term, proven solution to address growing demand for underarm sweat, odor and hair reduction in Europe —while driving value for providers."
Demand for lasting underarm solutions is surging. Europe's deodorant market is projected to reach $16.15 billion by 20311, with 50+ million consumers in the UK alone buying deodorants regularly2. Meanwhile, laser hair removal in the region is expected to grow to $1.22 billion by 2032, with underarms among the top areas treated3.
"This certification underscores miraDry's clinical performance and regulatory strength," said Irene Mo, Vice President of Quality and Regulatory at miraDry. "We've built a technology that meets the rigorous international standards, and safely delivers long-lasting relief from sweat, odor, and hair."
miraDry remains the only FDA-cleared and CE-marked system for permanent reduction of sweat, odor and hair follicles, now backed by EU MDR certification and improved treatment delivery. miraDry has proven to reduce odor in 97% of treated underarms4, with 89% of patients no longer bothered by underarm odor5. miraDry's unique mode of action is skin and hair color agnostic, unlike laser hair removal devices, and has proven to reduce hair by 70% in skin Fitzpatrick types I-V6.
About miraDry®
miraDry is an innovative, FDA-cleared treatment that provides a long-lasting solution for excessive underarm sweat, odor and hair. Safe, immediate and non-surgical, miraDry effectively reduces sweat glands and hair follicles in the underarms, offering lasting results and 90% patient satisfaction. miraDry remains the first and only of its kind and is available globally, with more than 500,000 patients treated to date and growing. Learn more at miraDry.com.
1 Verified Market Research, Europe Deodorants Market Report, 2023
2 LinkedIn Pulse, European Deodorant Usage Trends, 2023
3 Market Data Forecast, Europe Laser Hair Removal Market Outlook, 2023
4 Efficacy And Safety Of A Dermal Microwave Energy Device For Axillary Odor Reduction, Jordan V Wang, MD, MBE, MBA; Roy G Geronemus, MD; American Society for Dermatologic Surgery, Inc. 2024
5 Retrospective Multistudy Analysis of Axillary Odor Reduction After Microwave Treatment, Sarah Yagerman, MD et al; American Society for Dermatologic Surgery, Inc.; 2018
6A Prospective Study of Axillary Hair Reduction in Patients Treated With Microwave Technology. Jeremy A. Brauer, MD et al; American Society for Dermatologic Surgery, Inc. 2016
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