Canada OKs ophthalmic SD-OCT imaging system for patient use

Bioptigen 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.

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.

For more information, please visit http://www.bioptigen.com/products.html.

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