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Bioptigen receives FDA premarket approval for new OCT system
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RESEARCH TRIANGLE PARK, N.C. — Bioptigen has received clearance from the U.S. Food and Drug Administration to market its spectral domain optical coherence tomography system for imaging ocular microstructures, the company announced in a press release.
Bioptigen is a spinoff company from Duke University's biomedical engineering department. The new OCT system allows three-dimensional imaging of the retina and anterior ocular surfaces 50 times faster than previous generation devices, according to the press release. It also allows multiple scanning interfaces for in vivo imagining in humans and animals, the release said.
Bioptigen also received two phase 2 Small Business Innovation Research grants from the U.S. Small Business Administration. The awards will support the development of imaging systems for tracking ophthalmic diseases and high-throughput screening technologies for genetic phenotyping in animal models, according to the release.