2015-12-16
The U.S. Food and Drug Administration has granted Morrisville-based Bioptigen clearance to market its next-generation medical device that the company says improves ophthalmic surgical microscopes.
Bioptigen, which spun out of Duke University, was acquired by German imaging company Leica Microsystems in June. It received the FDA’s 510(k) clearance – the approval that relates to medical devices – for its EnFocus intrasurgical OCT system.
According to Leica, EnFocus allows ophthalmic more high-resolution…