Ophthalmic imaging technology company Bioptigen now has regulatory clearance in Canada on a handheld medical device developed to give doctors better images of their patients’ eyes.
The medical license from Health Canada allows Bioptigen to begin marketing its Envisu devices in Canada. The clearance follows a CE Mark awarded in Europe in December, which clears the systems for marketing in the European Union. A U.S. Food and Drug Administration decision on marketing clearance for the devices is still pending. Right now, the only U.S. use for the handheld devices is for research; Envisu systems are currently in use at 10 U.S. ophthalmic research institutions.
Research Triangle Park, North Carolina-based Bioptigen was founded in 2004 based on technology developed at Duke University‘s Pratt School of Engineering. The company initially developed the technology into a tabletop scanner that offered noninvasive imaging of the eye. That device received FDA 510(k) clearance in 2006. Bioptigen then developed a handheld scanner as an alternative that is easier to use with pediatric and nonambulatory patients.
When Investment Rhymes with Canada
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
Bioptigen is further developing its technology into a more compact handheld medical device that can be used with premature and neonatal infants, an effort supported by a $2.7 million grant awarded late last year by the National Institutes of Health.
[Photo from Flickr user orangeacid]
