Canada OKs ophthalmic SD-OCT imaging system for patient use

Bioptigen (Research Triangle Park, NC) has received a medical device license from Health Canada to begin marketing its handheld Envisu C2200 and C2300 spectral-domain optical coherence tomography (SD-OCT) ophthalmic imaging systems for patient use.

With regulatory approval to bring the systems to market in Canada as well as the European Union, the systems use low-power, near-infrared light to generate real-time, high-resolution, depth-resolved images of eye structures in adults and children, enabling heightened understanding of eye disease progression, detection, and treatment.

Dr. Eric Buckland, Biotigen president and CEO, notes that the spectral-domain ophthalmic imaging system's (SDOIS) handheld scanner is particularly useful for pediatric and non-ambulatory patients. As such, the National Institutes of Health (NIH) recently awarded the company a grant to investigate a compact, handheld device for use with premature and neonatal infants.

System availability in the US for patient use is dependent upon review and market clearance by the FDA.

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