FDA Breakthrough Device Designation for eyeWatch

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19.05.2021
Rheon Medical eyeWatch

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Rheon Medical’s eyeWatch technology, the world’s first adjustable glaucoma shunt for the treatment of refractory glaucoma. Currently marketing the device in European and Asian markets, the company expects to initiate US-based clinical trials evaluating the therapy early 2022.

Breakthrough Device Designation is granted by the FDA to specific medical devices that have the potential to provide a more effective treatment for life-threatening or irreversibly debilitating diseases. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review while preserving the statutory standards for marketing authorization.

“This marks an important step in our strategy to bring our most innovative glaucoma drainage device to American people suffering from refractory glaucoma", says Nikos Stergiopulos, CEO and founder of Rheon Medical. "We thank the FDA for the thorough review and the great recognition of the potential of the eyeWatch technology to provide a more effective treatment to such a debilitating disease."

The eyeWatch has already received the CE-mark in 2019 and is currently marketed in European and Asian markets. As far as commercialization goes, the Lausanne-based medtech started in February 2020 in Europe, but soon after, Covid-19 came along and basically put all elective surgeries like glaucoma on hold. A year later, things are gradually starting to pick up.

As Nikos Stergiopulous further explains, Rheon sells already in Switzerland, Spain and the United Kingdom and plans to expand in May and June on European markets such as Italy, Germany, France and Greece. In Asia the medtech active in the surgical treatment of glaucoma has just signed distribution agreements in Singapore, Hong Kong, the United Arab Emirates and Turkey. The goal is to have at least 15 to 20 reference medical centers implementing the eyeWatch by the end of 2021.

(Press release - ES)

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