Hand-Held Eye Imaging Device From Bioptigen Gets FDA 510(K) Clearance

Published: May 18, 2012

A non-invasive eye imaging system developed by medical device company Bioptigen now has regulatory clearance for use on patients in the United States. Bioptigen received 510(k) clearance from the U.S. Food and Drug Administration for its hand-held Envisu Spectral Domain Ophthalmic Imaging System. Bioptigen’s devices use a technology called optical coherence tomography. The company’s non-invasive device scans the eye without touching it. Bioptigen was founded in 2004 based on work from Duke University‘s Pratt School of Engineering. The Research Triangle Park, North Carolina company initially received 510(k) clearance on a tabletop scanner in 2006.

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