Israel-based Belkin Vision announced that it has received CE Mark for its Eagle device, making it the first automated, non-contact glaucoma laser treatment available within Europe. The CE Mark was granted under Medical Device Regulation (MDR) from its notified body DEKRA.
Belkin will begin controlled roll-out of the Eagle laser in Europe in the second half of 2022.
"The health economic impact of DSLT (Direct SLT) technology is potentially significant and is anticipated to allow for greater access to high-quality, contactless glaucoma treatment across Europe," Professor Sir Peng Tee Khaw, of Moorfields Eye Hospital and UCL, London, and member of the Belkin Scientific Advisory Board, said in a company news release.
"Current treatment options are more complex and DSLT can change the first-line glaucoma treatment paradigm improving patient quality of life, while at the same time improving access and allowing us to contribute to lower health care costs for both patients and health systems,” he added.
Historically, conventional laser treatment is manual, involving contact with the eye and is accessible mainly to a limited number of glaucoma specialists trained in laser technology who generally see advanced stage patients. Belkin says its DSLT technology is automated and therefore reduces the need for specialized training, thus allowing access to all ophthalmologists.
"The timing for the introduction of this technology is ideal as the UK National Institute for Healthcare Excellence (NICE) has recently recommended laser treatment as a first-line treatment for newly diagnosed glaucoma patients, following similar guidelines by the European Glaucoma Society (EGS)," according to Belkin.
Belkin Vision was recently selected to receive $20 million (€17.5M) of blended financing in grants and equity from the European Innovation Council Accelerator (EIC). This financing will support the company in the execution of its European commercialization.
CEO, Daria Lemann Blumenthal added, "We anticipate that our unique DSLT technology will become the new standard of first-line glaucoma care. Receiving CE mark under MDR is a pivotal moment for our company, as being able to offer Belkin Vision's Eagle in Europe, will transform the way glaucoma is treated. We look forward to accelerating our collaboration with doctors and health systems across Europe."