A cellular-level adaptive optics retinal camera (rtx1, Imagine Eyes) has received CE mark approval in the European Union.
Orsay, France, and Milan, Italy-Imagine Eyes has received regulatory approval to market its cellular-level adaptive optics retinal camera (rtx1) with the CE mark in the European Union (EU).
The announcement was made at the European Society of Retina Specialists Congress.
“This is an important event, as it marks the first time that an instrument specifically designed to image the retina at the cellular scale has received the CE mark for use by clinical ophthalmologists,” said Nicolas Chateau, Imagine Eyes chief executive officer. “The [camera] can allow doctors to visualize their patients’ retinas with a level of detail heretofore unachievable in the clinic. They will be able to observe many of the cellular and microvascular structures that can be affected by the diseases that threaten the vision of millions of people every year.”
The camera is available outside of the EU for use as a research-use-only device.
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