Bioptigen ophthalmic SD-OCT system earns CE Mark

Medical device developer Bioptigen (Research Triangle Park, NC) has received regulatory approval to market its handheld Envisu C2000-series ophthalmic spectral-domain optical coherence tomography (SD-OCT) systems for clinical use within the EU. The systems use low-power, near-infrared (IR) light to generate real-time, high-resolution, depth-resolved images of eye structures, enabling further understanding in disease progression, detection, and treatment.

The Envisu C2000-series should prove especially useful for physicians treating non-ambulatory patients, as well as those suffering from conditions such as nystagmus, which causes involuntary eye movement, says Dr. Eric Buckland, Bioptigen's president and CEO.

Availability of Envisu C-series handheld clinical ophthalmic imaging systems in the U.S. is dependent upon review and market clearance by the U.S. FDA.

The National Institutes of Health recently awarded Bioptigen a grant to investigate a compact, handheld device for use with premature and neonatal infants.

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