Bioptigen ophthalmic OCT system garners FDA approval

Bioptigen has received FDA 510(k) clearance to begin commercializing its handheld Envisu spectral-domain optical coherence tomography (SD-OCT) devices for patient use.

Bioptigen (Research Triangle Park, NC) has received FDA 510(k) clearance to begin commercializing its handheld Envisu spectral-domain optical coherence tomography (SD-OCT) devices for patient use. This falls on the heels of a grant awarded by the National Institutes of Health (NIH) to further investigate ophthalmic imaging solutions for premature and neonatal infants, as well as regulatory approval from Canadian, European, and Australian authorities.

The system aids in the diagnosis of physiological and pathological conditions of the eye through non-contact optical imaging. In receiving this regulatory clearance, the OCT system is the first of its kind commercially available in the U.S. for handheld and pediatric imaging.

The system's ergonomic, handheld scanner enables imaging of patients of all ages and conditions, while interchangeable lenses allow clinicians to image various structures of the eye.

For more information, please visit http://bioptigen.com/oct_news_jan12.html.

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