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Bioptigen imaging system receives CE mark approval

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RESEARCH TRIANGLE PARK, N.C. — The Envisu C2000 spectral domain optical coherence tomography imaging system from Bioptigen has earned CE mark approval for clinical use in the European Union, according to a company press release.

The hand-held system uses low-power, near-infrared light to create real-time, high-resolution, depth-resolved images of eye structures, according to the release.

Because it is hand-held, the system could be helpful in treating non-ambulatory patients, as well as those suffering from conditions that cause involuntary eye movements, such as nystagmus, Eric Buckland, PhD, Bioptigen president and CEO, said in the release.

"Physicians in Europe play a critical role when it comes to advancing non-invasive medical technologies," Dr. Buckland said. "Bioptigen looks forward to collaborating with these professionals as they develop new best practices based on standards that benefit patients worldwide."

The system has not yet been reviewed by the U.S. Food and Drug Administration for use in the United States.