Bioptigen, a spin-out from Duke University’s Biomedical Engineering Department, has been cleared to begin commercialization of its unique, non-invasive eye scanner.
The RTP-based startup said Friday that the Food and Drug Administration had granted marketing approval for its imaging system.
Bioptigen also said it has received two additional federal research grants.
“These events are a testament to our team and to our progress in developing the highest performance and most versatile research grade SDOCT imaging systems,” said Eric Buckland, Bioptigen’s chief executive officer.
The FDA-approved imaging system is designed to deliver micro-scale, 3D images of the retina and other eye surfaces 50 times faster than other scanners. The company believes the scanners, called spectral domain optical coherence tomography imaging systems, or SDOCT, will be useful in exams for eye diseases such as glaucoma.
Bioptigen is developing other imaging systems for use inside or outside of the body as well as image-processing software.
One of the grants is for use in further development of SDOCT technology. The other is for a system that can be used at the genetic level.
The amounts of the grants were not disclosed.
Last year, Bioptigen closed on $1.3 million in venture financing.