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 company initially received 510(k) clearance on a tabletop scanner in 2006.

The newer handheld scanner is intended for patients of all ages, including babies and children who may not be as comfortable with the tabletop device. The hand-held Envisu can scan patients whether they are upright or lying down.


Canada awarded Bioptigen regulatory clearance earlier this year. A CE Mark in Europe was awarded last December, clearing the way for Bioptigen to market the medical device in the European Union. The device also has marketing approval in Australia.

Bioptigen is also developing its ophthalmic imaging technology for devices that can be used with premature and neonatal infants. That research is being supported by a $2.7 million National Institutes of Health grant awarded last year.